Clinical Trials
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Urological and Kidney Diseases
The Pharmacokinetics of MK-7145 Following Single Dose Administration in Participants With Moderate Renal Insufficiency (MK-7145-018)
Apr 2013The primary purpose of this study is to obtain a preliminary pharmacokinetic profile of MK-7145 2 mg immediate release (IR) following single-dose administration in male participants with moderate renal insufficiency. In addition, the study will evaluate the pharmacodynamic effect of a single dose of MK-7145 2 mg IR on 24-hour net natriuresis in male participants with moderate renal insufficiency.
Multi-Center Randomized Clinical Trial Irreversible Electroporation for the Ablation of Localized Prostate Cancer
Apr 2013Multi-centre Randomized Clinical Trial: 200 patients with confirmed unilateral high-volume low risk (Gleason score 3 + 3) or intermediate risk prostate cancer (Gleason score 3 + 4) will undergo an IRE treatment. These patients will be randomized into one of the two groups of the study. Group 1: Hemi-ablation of the prostate at the side of the positive biopsies (hemi-ablation) Group 2: Total ablation of the prostate (total ablation) Patients will have an ultrasound of the prostate and the imaging data will be entered into the Planning Software system of the IRE-device. The volume of the prostate is measured and a specified ablation zone will be determined. The patients will be admitted for overnight stay in the hospital on the morning of the scheduled IRE procedure. The IRE will be performed under general anaesthetic and the specified zone identified in the planning stage will be ablated. Two to four IRE electrode needles will be placed into the prostate under ultrasound image guidance with a perineal approach using a brachytherapy grid. When the needles are in place, electric pulses of one to two minutes duration are used to ablate the specified zone. The total procedure time will be approximately 1 hour. Safety data will be collected and patients will be followed up at 1 day post-operatively, 1 month, 3 months, 6 months and 1, 2 and 3 year(s) post IRE.
Sutent Rechallenge In mRCC Patients (RESUME)
Mar 2013Retrospective and prospective study in mRCC patients treated with sutent in first line and rechallenged by Sutent in 3rd and 4th line.
Sutent Rechallenge In mRCC Patients (RESUME)
Mar 2013Retrospective and prospective study in mRCC patients treated with sutent in first line and rechallenged by Sutent in 3rd and 4th line.
Atorvastatin and Prostate Cancer (ESTO1)
Mar 2013This single-center, randomized, double-blind trial assesses the impact of short-term atorvastatin administration on proliferation activity, apoptotic rate and histological inflammation in prostate tissue.
Paricalcitol Over Inflammatory Parameters on Chronical Kidney Disease Patients (SENPARIC)
Mar 2013Use of Paricalcitol in stage Vd Chronic Kidney Disease patients, over the effect of inflammatory and oxidative stress parameters.
A Study in Maintenance Kidney Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based
Mar 2013The primary purpose is to assess the benefits and risks of changing from Cyclosporine or Tacrolimus to Belatacept between 6-36 months after kidney transplant.
Does Posterior Reconstruction of the Rhabdosphincter Improve Early Recovery of Continence After Robotic-Assisted Radical Prostatectomy? (PRR)
Mar 2013The present study is a multicenter randomized, controlled trial, whose aim is to verify the effect of the posterior reconstruction of the rhabdosphincter after robot-assisted radical prostatectomy on early recovery of urinary continence.
Systematic Transplantectomy Versus Conventional Care After Kidney Graft Failure (DESYRE)
Mar 2013This study is designed to assess the following hypothesis: "early and systematic transplantectomy under a well-conducted immunosuppression is associated with a decreased risk of anti-HLA immunization against a conservative attitude including a gradual reduction of immunosuppression, with or without a transplantectomy performed for cause (clinical event)".
Study of Weekly Radiotherapy for Bladder Cancer (HYBRID)
Mar 2013In patients with muscle invasive bladder cancer not suitable for cystectomy or daily radiotherapy we aim to assess: - whether treatment using adaptive planning can be successfully delivered at multiple sites across the UK and results in acceptable levels of toxicity - the local tumour control rate achieved by hypofractionated weekly radiotherapy - the requirement to treat with adaptive planning.
Study of Safety and Tolerability of BPS804 in Patients With Late-stage Chronic Kidney Disease
Mar 2013The purpose of the study is to evaluate the safety, tolerability, and PK following a single administration of BPS804 in patients with chronic kidney disease stage 5D (CKD-5D) on hemodialysis.
RAS Blockade at Bedtime Versus on Awakening for Aldosterone Breakthrough (IRAB2)
Feb 2013The objective is to show that the frequency of aldosterone breakthrough is lower when RAS blockers are given at bedtime compared to on awaking, and to analyze the determinants and consequences of aldosterone breakthrough.
RAS Blockade at Bedtime Versus on Awakening for Aldosterone Breakthrough (IRAB2)
Feb 2013To show that the frequency of aldosterone breakthrough is lower when RAS blockers are given at bedtime compared to on awaking, and to analyze the determinants and consequences of aldosterone breakthrough.
Efficacy Study of Antimicrobial Catheters to Avoid Urinary Infections in Spinal Cord Injured Patients (ESCALE)
Feb 2013The purpose of this trial is to make a comparison between the use of antiseptic silver alloy-coated silicone urinary catheters and the use of conventional silicone urinary catheters in spinal cord injured patients to prevent urinary infections.
CE-US in Renal Transplantation
Feb 2013Acute allograft dysfunction is often observed in the first weeks after kidney transplantation. Renal biopsy is universally considered the gold standard procedure for differential diagnosis of acute allograft dysfunction secondary to intraparenchymal causes. Kidney biopsy, however, is an invasive procedure that is time and cost consuming. Moreover, it may but not contribute to clinical diagnosis in about 10% of cases because of the impossibility to perform the analysis or of inadequacy of the biopsy sample. Availability or readily applicable non-invasive procedures might therefore allow increasing the performance of differential diagnosis of allograft dysfunction. In the recent years, a novel US imaging technique, namely contrast-enhanced ultrasound (CE-US),has been developed. The agent used in this study, Sonovue microbubbles consist of a central sulphur hexafluoride core with a surrounding phospholipid monolayer and last for several minutes in the systemic circulation before spontaneous degradation with absorption of the gaseous component by the lungs and the phospholipid shell by the liver. With the use of gasfilled microbubbles that act as scatterers within the blood stream and the development of low-MI ultrasound techniques that allow the visualization of the bubbles without destroying them, it is possible to improve the depiction of vessels and have access to structural and functional information on the microcirculation. Moreover SonoVue microbubbles are not nephrotoxic and can be safely used to evaluate kidney disfunction. Thus, whether a. different patterns of parenchymal perfusion detected by CE-US can be associated with different patterns of renal graft involvement during acute renal function deterioration and b. whether, conversely, different patterns of parenchymal perfusion detected by CE-US may help predicting different patterns of renal involvement will be investigated in 20 deceased or living donor kidney graft recipients.
Evaluating the Effect of Pre-TURBT Intravesical Instillation of Mitomycin C (MMC) Mixed With TC-3 Gel in Patients With Non Muscle Invasive Bladder Cancer (NMIBC) (NMIBC TURBT HG)
Feb 2013In the proposed study the investigators aim to evaluate the effect of the standard of care dose (40mg) of MMC mixed with TC-3 gel (with sustained release mechanism on the drug) on low risk recurrent NMIBC lesions and to compare our findings to instillation with the standard mode of instillation- 40mg MMC in water in order to examine our hypothesis that MMC mixed with TC-3 gel will have at least non-inferior and even superior results over the standard instillation mode
A Study Comparing AZD2014 vs Everolimus in Patients With Metastatic Renal Cancer (ZEBRA)
Feb 2013When kidney cancer spreads beyond the kidney, it is known as metastatic kidney cancer. This is very difficult to treat and almost all patients will die of their disease within 2 years of the dignosis. Sunitinib and other related drugs (e.g. pazopanib) have become standard therapy for untreated patients with metastatic kidney cancer. They target a growth factor known as VEGF which is important in treating kidney cancer. Although the results with this drug are impressive, patients develop resistance to the drug and stop therapy. It is currently standard practice is to give everolimus when resistance to sunitinib occurs; this is associated with clear clinical benefit. However the average time to cancer regrowth with everolimus is only 5 months. It is thought this might be because, everolimus only partially inhibits its target (TORC 1 and TORC 2). Therefore further improvement in treating patients is required. AZD2014 is a promising new drug which does inhibit both TORC 1 and TORC 2 and is therefore worthy of investigation in renal cancer as it theoretically could may have advantages over everolimus. Therefore study compares AZD2014 to everolimus in the setting where everolimus is used as standard of care. (e.g. in patients who have failed drug like sunitinib). The study is a randomised trial allowing us to quantify the benefit and potential for further development of AZD2014. Repeat Xrays (CT scans) will be used to assess if the new drug delays tumour growth. Patients will be closely followed up in clinic to ensure safety. A maximum of 122 patients will be recruited into this multi centre national trial. The primary goal of the study is to investigate if AZ2014 delays the time for cancer regrowth (time to progression) compared to everolimus.
Observational, Non-interventional, Non Comparative Real Life Data Collection of Depo-Eligard® 7.5 mg, 22.5 mg and 45 mg in Male Prostate Cancer Patients (TREMODI)
Feb 2013Observational, Non-interventional, Non Comparative Real Life Data Collection of Depo-Eligard® 7.5 mg, 22.5 mg and 45 mg in Male Prostate Cancer Patients (TREMODI)
Changes of cytokines and regulatory T cells in renal transplant recipients after switch to the mTOR inhibitor Everolimus. A Single center trial, non-blinded, non-randomized.
Feb 2013Changes of cytokines in renal transplant recipients after switch of immunosuppression from CNI (calcineurin inhibitor) to the mTORi (mTOR inhibitor) Certican.
A Phase I Trial of AZD3965 in Patients With Advanced Cancer
Feb 2013The main aims of this clinical study are to find out the maximum dose that can be given safely to patients, the potential side effects of the drug and how they can be managed and what happens to AZD3965 inside the body.
Safety and Efficacy of Irreversible Electroporation in Ablation of Prostate Cancer in Humans
Feb 2013Up to 16 patients with confirmed low- or intermediate risk prostate cancer scheduled for a radical prostatectomy will be asked to have the Irreversible Electroporation (IRE) procedure approximately 30 days prior to the prostatectomy. Ablation with IRE will be performed using similar planning criteria, procedure protocol, instruments and software used for brachytherapy, a conventional targeted radiation therapy where radioactive seeds are implanted into prostate tumours. Patients will have an ultrasound of the prostate and the imaging data will be entered into the Planning Software system. The volume of the prostate is measured and a specified ablation zone will be determined. The IRE will be performed under general anaesthetic and the specified zone identified in the planning stage will be ablated. Four IRE electrode needles will be placed into the prostate under ultrasound image guidance. When the needles are in place, electric pulses of one to two minutes duration are used to ablate the specified zone. The total procedure time will be approximately 1 hour. Safety data will be collected and patients will be followed up at 1 week, 2 weeks post IRE, pre- prostatectomy, post prostatectomy and 1 week post prostatectomy. The safety data collection is at 2 weeks post IRE. Before the IRE procedure, patients will have a Magnetic Resonance Imaging (MRI) and Contrast Enhanced Ultrasound (CEUS) of the prostate. The patients will have their scheduled prostatectomy at approximately 30 days after the IRE procedure. Pre-prostatectomy, the ablation zone will be radiologically assessed by a control MRI/CEUS. Post prostatectomy, efficacy of ablation will be determined by histological examination of the prostate by the Pathology Department and measured as complete or incomplete ablation. The primary outcome is safety as measured by the composite of procedural device and post procedural adverse events, measured with the Common Terminology Criteria for Adverse Events v 4 (CTCAE), Expanded Prostate Cancer Index Composite (EPIC) score, International Prostate Symptom Score (IPSS) or required catheterization time and International Index of Erectile Function (IIEF) and efficacy of ablation determined by histological examination post prostatectomy. Secondary outcomes will be patients procedure satisfaction measured by patient satisfaction questionnaire, post procedural pain management and Visual Analogue Scale (VAS) pain score, time to ambulation, length of hospital stay.
Trial of RNActive®-Derived Prostate Cancer Vaccine in Metastatic Castrate-refractory Prostate Cancer
Feb 2013The purpose of this study is to determine whether the new RNActive-derived prostate cancer vaccine CV9104 prolongs survival in patients with asymptomatic or minimally symptomatic metastatic prostate cancer that is castrate resistant.
TrAnsCatHeter Intravascular Ultrasound Energy deliVery for rEnal Denervation (ACHIEVE)
Feb 2013The ACHIEVE study is a single-arm, open-label, prospective, post-market follow-up study to be conducted on fifty (50) eligible patients with a twelve month follow-up period.
To Evaluate the Technique and Effects of Separating the Prostate and Rectum With Hyaluronic Acid During Radiotherapy (NoHarm)
Feb 2013The dominating problem after local radiotherapy of prostate cancer is rectal toxicity. If the rectum could be completely moved out of the treated volume, a substantial decrease of rectal toxicity seems reasonable. In this study we will develop and evaluate a new transrectal injection technique where hyaluronic acid (HA) is injected in the space between the prostate and the rectum prior to external beam radiotherapy to increase the physical distance between prostate and rectum.
The effects of n-3 polyunsaturated fatty acids on glomerular filtration rate, proteinuria, fibrosis and inflammation in the kidney transplant and cardiovascular risk markers in kidney transplant recipients: a randomized double blinded placebo controlled intervention study.
Feb 2013To study the glomerular filtration rate in kidney transplant recipients receiving supplementation of n-3 polyunsatturated fatty acids compared to placebo.
A Phase 3, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of FG-4592 for the Treatment of Anemia in Chronic Kidney Disease Patients not on Dialysis
Feb 2013To evaluate the efficacy of FG-4592 in the treatment of anemia in non-dialysis Chronic Kidney Disease (CKD) subjects.
NEPTUNE: A Randomised Phase II Study of Neoadjuvant TAK-700 and Leuprorelin Acetate versus Surgery Alone in Intermediate and High Risk Clinically Localized Prostate Cancer
Feb 2013To investigate if neoadjuvant TAK-700 with LHRH agonists and prostatectomy is associated with a delay in progression- free survival compared to prostatectomy alone. The primary endpoint will assess the 3 year biochemical progression free survival (PSA)
Bioavailability Study of ODM-201 in Subjects With Metastatic Chemotherapy-naive Castration-resistant Prostate Cancer (ARAFOR)
Feb 2013A study to investigate which of two different tablet formulations of ODM-201 is best suited for use in the further development of the compound in the treatment of metastatic chemotherapy-naive castration-resistant prostate cancer. Patients successfully completing the bioavailability study will be able to receive further treatment with the current capsule formulation of ODM-201 until progression of their disease with the safety and tolerability of ODM-201 being assessed throughout.
Phase II Pharmacokinetics, Efficacy, and Safety of Belatacept in Pediatric Renal Transplant Recipients
Jan 2013The purpose of this study is to assess the pharmacokinetics (PK) efficacy and safety of Belatacept in stable pediatric renal transplant recipients.
Safety and Efficacy of Radiotherapy Combined With a 6-month LH-RH Agonist and Abiraterone Hormone Therapy Treatment in Biochemically-relapsing Prostate Cancer Following Surgery (CARLHA)
Jan 2013As there is no prospective data on the combination of abiraterone and salvage radiotherapy, the aim of this study is to further evaluate the safety profile of abiraterone acetate plus prednisone in patients with prostate cancer who are biochemically relapsing after surgery and undergo salvage radiotherapy with 6-months LH-RH agonist. The investigators hypothesize that the toxicity profile of both treatments should not potentiate each other. This study will also provide preliminary data on the efficacy of this combination.
The Impact Of Periodontal Disease Treatment On The General Health Status In Chronic Haemodialyzed Patients (PAROHEM)
Jan 2013Several studies revealed a direct relationship between the severity of periodontal inflammation and CRP (NHANES III, Dumitriu HT et al, 1998). In patients without any other source of inflammation but PDD, proper dental treatment of the disease decreased CRP to normal levels (Dumitriu H.T. et al., 1998; D'Aiuto F. et al, 2004; Borawski J. et al., 2007) Moreover, a direct link between high levels of CRP and atherosclerotic complications has been found in studies conducted both in general population (Ridker PM, et al., 1998; Koenig W, et al., 1999) and in HD subjects (Westhuyzen J, et al., 2000; Iseki K., et al., 1999; Zimmermann J, et al. 1998).
Evaluation of Evodial Hemodialyzer Selectivity Modifications (Evodial +)
Jan 2013Evodial +hemodialyzer consists of an evolution of the existing CE marked Evodial device, with respect to the hemodialyzer membrane removal characteristics. Different membrane prototypes configurations are proposed (3 versions in total), with the objective to modulate the hemodialyzer removal capacities (convective and adsorptive capacities). Materials(including heparin grafted specifications) as well as the sterilization process are identical to the Evodial hemodialyzer. Based on available preclinical data , a clinical study is requested to document in vivo the different prototypes removal capacities with respect to middle Molecular Weight (MW) reference toxins such as b2 Microglobulin and collect data with regards to protein loss.
Shared Care Follow-up After Chemotherapy for Testicular Cancer (SCFU-TC)
Jan 2013The aim of this study is to develop and evaluate a shared care survivorship care plan (SCP) to follow-up patients with metastatic testicular cancer after completion of chemotherapy that resulted in complete remission.
A Phase I/IIa Study of UV1 Vaccine in Patients With Prostate Cancer (UV1/hTERT2012P)
Jan 2013In this study, up to 21 patients with metastatic prostate cancer will receive UV1 (a therapeutic synthetic peptide vaccine) at different dose levels. The safety and tolerability of UV1 as well as immunological response will be assessed. The purpose of this study is to select a biological dose of peptides for further clinical trials.
Perioperative Chemotherapy for Patients With Locally Advanced Bladder Cancer (VESPER)
Jan 2013Radical cystectomy remains the gold standard treatment for invasive non metastatic transitional cell cancer (TCC) of the bladder. In contemporary series, specific survival rates are about 60 to 65% at 5 years, decreasing for locally advanced disease to 45-50% in patients with nonorgan-confined lymph-node negative tumours and to 30-35% in patients with lymph node positive tumours. Perioperative chemotherapy (adjuvant ou neoadjuvant) has been developed in order to improve these results. Thanks to randomized trials and meta-analysis, it can be concluded that perioperative chemotherapy increases overall survival with an absolute benefit of 5%, equating to a survival rate of 50% at 5 years for nonorgan-confined tumours. However, the chemotherapy administration time and the optimal chemotherapy regimen to be delivered are not yet determined. Meta-analyses have shown that the benefit is only observed for chemotherapy regimens including cisplatin. In daily management 4 to 6 cycles of gemcitabine and cisplatin are delivered since this combination has been shown to yield a similar efficacy with a better tolerance as compared to the MVAC regimen (methotrexate, vinblastine, doxorubicin and cisplatin) in the metastatic setting. As HD-MVAC has been shown to be associated with higher response rates than MVAC in bladder metastatic disease, also a better efficacy of HD-MVAC can be suspected in the perioperative setting. Investigators therefore designed a randomized phase III study to compare the efficacy of GC and HD-MVAC in term of progression-free survival in patients for whom chemotherapy has been decided, before or after radical cystectomy. Secondary endpoints include overall survival, side effects, response rate in the neoadjuvant setting and ancillary studies focusing on gemcitabine and cisplatin sensitivity. The total number of patients projected is 500. The number of patients is based on the median progression-free survival rate of 50% at 3 years observed in patients treated with GC (standard arm A) in the perioperative setting. An absolute improvement of 10% (HR=0.74) is expected with HD-MVAC (experimental arm B) with a=0.05 and b=0.20. An interim analysis is planned after the occurrence of 174 events. With an estimated uniform accrual rate of 140 patients per year for 3.5 years and exponential survival, the final analysis is expected to occur 8 years after the start of the trial.
Study of LY3016859 in Participants With Diabetic Nephropathy
Jan 2013The purpose of this two-part study is to investigate the safety, tolerability and efficacy of LY3016859 after multiple intravenous (IV) dosing's in participants with diabetic nephropathy (DN). Part A will be dose escalation for safety and tolerability and Part B will evaluate Proteinuria.
Effect of chemotherapy on endothelial function in patients with testicular cancer
Jan 2013The aim is to study possible adverse effects of chemotherapy on endothelial function1
A Phase III, Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of MK-3102 Versus Placebo in Subjects with Type 2 Diabetes Mellitus with Moderate or Severe Chronic Kidney Disease or Kidney Failure on Dialysis Who Have Inadequate Glycemic Control
Jan 2013After 24 weeks, to assess the safety (incidence of adverse events) and tolerability (discontinuation rate) of MK-3102. After 54 weeks, to assess the safety (incidence of adverse events) and tolerability (discontinuation rate) of MK-3102.
Renal Denervation in Treatment Resistant Hypertension (ReSET-2)
Jan 2013The purpose of this double-blind, randomized and sham controlled study is to investigate the blood pressure lowering effect of renal denervation by catheter based ablation in the renal arteries in patients with milder forms of treatment resistant hypertension. The effect on blood pressure will be evaluated by 24-hour ambulatory blood pressure measurements at baseline and after 3 and 6 months of follow up. Secondary endpoint evaluation comprises hemodynamic assessment by applanation tonometry and the cold pressor response.
Effect of Macrodex versus lactated Ringer on coagulation in major surgery. A randomised clincal trial.
Jan 2013The objective is to assess the coagulation competence of the fluids
Adaptive Radiotherapy Using Plan Selection for Bladder Cancer (plan selection)
Jan 2013This protocol describes a Phase 2 clinical trial of online adaptive Radiotherapy, using a library of 3 dose plans corresponding to Small, Medium and Large size bladder. The procedure includes 'Common Toxicity Criteria for Adverse Effects'(CTCAE) for registration of adverse effects (baseline, every 2'nd week during RT, 2 weeks, 3, 6, 12 and 24 month after RT) as well as cineMR for intra-fractional motion (baseline and every week during RT). Patients receive standard non-adaptive RT in the first week. Delineations of the bladder on the Cone-Beam scans (CBCT) from first week of treatment are used for planning the Small and Medium size bladder plans. Large size plan are the standard non-adaptive treatment plan used for the first week of treatment. A margin of 5 mm for intra fractional movement is used.
BOTOX® for the Treatment of Urinary Incontinence due to Neurogenic Detrusor Overactivity in Patients with Multiple Sclerosis
Dec 2012Evaluate the safety and efficacy of 100 U BOTOX compared to placebo injected into the detrusor for the treatment of urinary incontinence due to NDO resulting from MS, in patients who are not catheterizing at baseline, and whose symptoms have not been adequately managed with an anticholinergic therapy.
Efficacy Study of Sunitinib and Everolimus (Rotational Versus Sequential Arm) in Patients With Metastatic Clear Cell Renal Cancer (SUNRISES)
Dec 2012The objective of this study is to assess the progression-free survival, of patients who receive rotations of sunitinib and everolimus versus patients who receive sunitinib as a first line treatment followed by everolimus when progression occurs.
A Randomized, Double-blind, Comparative Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Subjects With High-Risk, Metastatic Hormone-naive Prostate Cancer (mHNPC)
Dec 2012To determine whether abiraterone acetate in combination with low-dose prednisone and ADT is superior to ADT alone in improving survival in subjects with mHNPC with high risk prognostic factors.
A randomized controlled clinical trial to determine if a combined screening /treatment programme can prevent premature failure of renal transplants due to chronic rejection in patients with HLA antibodies.
Dec 2012Determine the 3-year graft failure rate in patients testing positive for HLA Ab at baseline or within 3 years of randomization who receive an optimized anti-rejection medication intervention with prednisone, Tac and MMF (‘treatment’), compared to a control group who test positive for HLA Ab at baseline or within 3 years post-randomization who remain on their established immunotherapy and whose clinicians are not aware of their Ab status.
Treat-To-Target Trial of Continuous Subcutaneous , sensor-augmented insulin-pump therapy in new-onset diabetes after transplantation (SAPT-NODAT): Efficacy and Safety of an Intensive Insulin Protocol in Renal Transplant Recipients Receiving a Tacrolimus-based Immunosuppression
Dec 2012To demonstrate superiority of continuous subcutaneous sensor-augmented insulin-pump therapy (SAPT) with an insulin pump from Medtronic (Paradigm® Velo) for a period of approximately 3 months post-transplantation, and aiming for a pre-supper target capillary blood glucose level of 110 mg/dL against post-transplant hyperglycemia, in comparison to conventional treatment, and as evaluated by HbA1c at 3 months post-transplantation (comparison will be made against the simultaneously monitored control group of the ITP-NODAT study [=arm B])
Treatment of Urge Urinary Incontinence in Women After Failure of Cesa or Vasa (URGE II)
Nov 2012Urge urinary incontinence can be a disorder caused by destroyed pelvic structures. We repaired the uteri-sacral ligaments (USL) by cesa or vasa. The study evaluates if solifenacin can lead to continence after surgery or if also the pubo-urethral ligaments (PUL) need to be repaired.
Insulin Therapy for the Prevention of New Onset Diabetes after Transplantation (ITP-NODAT) Prospective Study in Non-Diabetic De Novo Kidney Transplant Recipients
Nov 2012This study aims to assess the effects of early insulin therapy in previously non-diabetic de novo kidney transplant patients in reducing the incidence of new onset diabetes in particular and abnormal glucose metabolism in general during subsequent follow-up.
Surgical vs. Medical Treatment of Urge Urinary Incontinence in Women (URGE I)
Nov 2012The purpose of this study is to determine if pelvic surgery can improve urge urinary incontinence in women more than standard medical treatment.
A Double Blind Randomised Study of Lapatinib and Placebo in Metastatic TCC of the Urothelium
Nov 2012To compare progression-free survival in patients with HER1- and/or HER2-overexpressing stage IV bladder cancer who have been randomized to maintenance therapy with lapatinib ditosylate or placebo following first-line chemotherapy.
Thiazide diuretics versus calcium channel blockers for the treatment of tacrolimus-induced hypertension after kidney transplantation: a single-center randomized cross-over trial.
Nov 2012To compare the blood pressure lowering effect of thiazides against calcium channel blockers in stable kidney transplant recipients with hypertension who are treated with CNIs.
Trial of 1 Cycle of Adjuvant BEP Chemotherapy in High Risk, Stage 1 Non-seminomatous Germ Cell Testis Tumours
Nov 2012High-risk stage 1 NSGCTTs are curable with careful surveillance followed by 3 cycles of BEP (bleomycin, etoposide, cisplatin with 500mg/m2 of etoposide per cycle) chemotherapy for the 40-50% of cases experiencing recurrence. Alternatively, adjuvant chemotherapy with 2 cycles of BEP(at a lower dose than that used for advanced disease - etoposide 360mg/m2) for these patients achieves the same outcome and avoids intensive surveillance, but delivers 33% more chemotherapy cycles on a population basis. If a single cycle of BEP at the dose used in advanced disease had a similar high rate of relapse-free survival (cure) to that seen with two lower dose cycles, this would reduce the overall burden of chemotherapy and healthcare resource usage and would be likely to lead to a change in practice globally.
A four-week, Phase IIa, randomized, active-controlled, parallel-group, multi-center study to evaluate the safety, efficacy and pharmacokinetics of switching subjects from a stable dose of recombinant human erythropoietin to GSK1278863 in hemodialysis-dependent subjects with anaemia associated with chronic kidney disease
Oct 2012Estimate the relationship between dose of GSK1278863 and hemoglobin (Hgb) response following switching from a stable dose of rhEPO in subjects undergoing HDD.
A four-week, Phase IIa, randomized, active-controlled, parallel-group, multi-center study to evaluate the safety, efficacy and pharmacokinetics of switching subjects from a stable dose of recombinant human erythropoietin to GSK1278863 in hemodialysis-dependent subjects with anaemia associated with chronic kidney disease
Oct 2012Estimate the relationship between dose of GSK1278863 and hemoglobin (Hgb) response following switching from a stable dose of rhEPO in subjects undergoing HDD.
Does oral sodium bicarbonate therapy improve function and quality of life in older patients with chronic kidney disease and low-grade acidosis? A multicentre randomized placebo controlled trial
Oct 2012To determine whether oral bicarbonate therapy improves physical function and health-related quality of life compared to placebo in older people with Chronic Kidney Disease (CKD) and mild acidosis
A phase III single arm study to evaluate the efficacy, safety and local tolerability of a subcutaneous 3‑month formulation of triptorelin pamoate (11.25 mg) in patients with locally advanced or metastatic prostate cancer.
Oct 2012To confirm the efficacy of triptorelin pamoate (11.25 mg)prolonged release (PR) formulation by inducing castration (defined as serum testosterone level of <50 ng/dL or <1.735 nmol/L) at Day 29 and maintaining castration at Day 183 (after receiving two subcutaneous (s.c.) administrations of triptorelin pamoate, 3 months apart).
A Randomized, Double-blind, Comparative Study of ZYTIGA (Abiraterone Acetate) Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Subjects With High-Risk, Metastatic Hormone-naive Prostate Cancer (mHNPC)
Oct 2012To determine whether ZYTIGA in combination with low-dose prednisone and ADT is superior to ADT alone in improving survival in subjects with mHNPC with high risk prognostic factors.
Multicentric Comparative Randomized Study of the Single-incision Sling Ajust® Versus Suburethral Transobturator Slings.
Sep 2012The objective of this study is to establish if the effectiveness of the SIMS Ajust® is non-inferior to that of a standard TOT, as well as to compare the comorbidity of both procedures. Owing to the new appearance and fast evolution of these procedures, randomized comparative studies with SIMS are required in order to determine its place in the treatment of SUI.
Biomarkers Before and After Nephrectomy of Locally Advanced or Metastatic Renal Cell Carcinoma Treated With Everolimus (NEORAD)
Sep 2012A Comparison of Blood and Tissue Biomarkers Before and After Nephrectomy in the First-line Setting With Everolimus in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma
Stem Cells Treatment for the Local Feminine Stress Urinary Incontinence Treatment (HULPURO)
Sep 2012Evaluate the feasability and security of the autologous ASC for the femenine stress urinary incontinence
An Open-label, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Darbepoetin alfa in Paediatric Subjects From Birth to Less than 1 Year of Age With Anemia due to Chronic Kidney Disease
Sep 2012To evaluate the safety and tolerability of darbepoetin alfa following single 1.5 microgram/kg subcutaneous (SC) dose administration in paediatric subjects < 1 year of age with anaemia due to chronic kidney disease
An Open-label, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Darbepoetin alfa in Paediatric Subjects From Birth to Less than 1 Year of Age With Anemia due to Chronic Kidney Disease
Sep 2012To evaluate the safety and tolerability of darbepoetin alfa following single 1.5 microgram/kg subcutaneous (SC) dose administration in paediatric subjects < 1 year of age with anaemia due to chronic kidney disease
A multicenter, randomized, doubleblinded, parallel-group, placebocontrolled study to assess the efficacy and safety of skeletal muscle-derived cell implantation in female patients with stress urinary incontinence
Sep 2012The aim of this clinical study is to show clinical efficacy and safety of SMDCs in patients suffering from SUI and to show superiority of SMDCs in female patients with moderately severe SUI over placebo.
A phase III, randomized, assessor-blinded, active-controlled, multicenter study of the efficacy and safety of APO-EPO as compared to Procrit® when given intravenously to patients with anemia and chronic kidney disease stage 5 on hemodialysis, currently not on epoetin replacement therapy
Aug 2012To assess the therapeutic equivalence of Apotex’s epoetin alfa (APO-EPO) versus US licensed epoetin alfa (Procrit®) for correction of the hemoglobin (Hb) concentration in patients with anemia and chronic kidney disease (CKD) stage 5 maintained on stable hemodialysis.
Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices (CAPTURE)
Aug 2012To monitor post-market performance through evaluation of short and long-term performance via: Efficacy / Safety / Patient reported outcomes
Treatment of TA Bladder cancer with high risk of recurrence – fluorescence cystoscopy with optimized adjuvant mitomycin-c
Aug 20121) To evaluate whether the adjuvant 6-weekly optimized MMC instillation therapy is better than single immediate postoperative instillation therapy in reducing recurrences. 2) To evaluate whether the PDD-guided TUR-BT is better than the conventional white light TUR-BT in reducing recurrence, which implies evaluation of whether the effect of PDD-guided TUR-BT is additive to MMC instillation therapy
A Phase 3, Randomized, Double-blind, Controlled Study of Cabozantinib (XL184) vs. Prednisone in Metastatic Castration-resistant Prostate Cancer Patients who have Received Prior Docetaxel and Prior Abiraterone or MDV3100
Aug 2012The objective of this study is to evaluate the effect of cabozantinib compared to prednisone on overall survival in men with previously treated metastatic castration-resistant prostate cancer with bone-dominant disease who have experienced disease progression on docetaxel-containing chemotherapy and abiraterone or MDV3100.
Safety, Tolerability and Effectiveness of Glocophage®SR in patients with type-2 Diabetes and Chronic Kidney Disease (eGFR 30 to 45mL/minute/1.73m2)
Aug 20121% Change in HbA1c at the end of study from baseline in the Glucophage® SR group of the study, compared to placebo.
A randomized phase II study to explore the efficacy and feasibility of upfront rotations between sunitinib and everolimus versus sequential treatment of first line sunitinib and second line everolimus until progression in patients with metastatic clear cell renal cancer.
Aug 2012Progression-free survival (PFS)
Urethral Length Measurement in Women Undergoing Suburethral Sling Operative Procedure
Aug 2012This is a prospective, non-randomized, observational, multicenter study in which urethral length is measured in women with surgically-correctable stress urinary incontinence who undergo a suburethral sling operative procedure.
Safety and Efficacy of tablets containing extract of Hibiscus Sabdariffa (HS) and Propoli versus placebo in the treatment of the cystitis with Ciproxin
Aug 2012To observe the safety of tablets containing an extract of Hibiscus Sabdariffa (HS) and Propoli versus placebo as co adjuvant for the treatment of cystitis in patients > o =18 years
A phase I/II trial of Cabazitaxel +/- Rhenium-188 HEDP in patients with metastatic castration resistant prostate cancer who progressed on or after a docetaxel containing treatment. The ReCab trial
Aug 2012To establish a safe and effective dosing schedule for repeated administration of Rhenium-188 HEDP combined with cabazitaxel in order to proceed with a Randomized Phase 2 trial designed to determine the clinical value of Rhenium-188 HEDP/cabazitaxel using overall survival as the primary endpoint. Patients included in the phase1 part with the dose schedule selected for the phase 2 part will be integrated in the final phase 2 analysis.
A randomised Phase II/III study of cabazitaxel versus vinflunine in metastatic or locally advanced transitional cell carcinoma of the urothelium
Jul 2012Phase II part: -efficacy of cabazitaxel compared to vinflunine in terms of improved objective response rate (ORR) of subjects with metastatic or locally advanced previously treated TCCU. Phase III part: -efficacy of cabazitaxel compared to vinflunine in terms of improved OS of subjects with metastatic or locally advanced, previously treated TCCU.
Phase Ib dose finding study of abiraterone acetate plus BEZ235 or BKM120 in patients with castration-resistant prostate cancer
Jul 2012Dose escalation part: Define maximum tolerated dose (MTD) and /or recommended dose for expansion (RDE) of the combinations abiraterone acetate + BEZ235 and abiraterone acetate + BKM120 by assessing the incidence of dose limiting toxicities (DLTs) in cycle 1. Dose expansion part: Assess anti-tumor activity of the combinations (abiraterone acetate + BEZ235 and abiraterone acetate + BKM120) in castration-resistant prostate cancer patients with abiraterone acetate failure as on treatment Prostate specific antigen (PSA) progression according to prostate cancer working group 2 criteria (PCWG2) by assessing PSA decline ? 30% at Week 12 or later.
A Randomized, Open-Label, Phase 3 Study of BMS-936558 vs. Everolimus in Subjects with Advanced or Metastatic Clear-Cell Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy Pharmacogenetics Blood Sample Amendment 01- dated 18-jun-12, version 1.0
Jul 2012The purpose of the study is to compare the clinical benefit, as measured by duration of overall survival, of BMS-936558 vs. Everolimus in subjects with advanced or metastatic clear-cell renal cell carcinoma who have received prior anti-angiogenic therapy.
Radiotherapy as an immunological booster in patients with metastatic melanoma or renal cell carcinoma treated with High-dose Interleukin-2: evaluation of biomarkers of immunologic and therapeutic response
Jul 2012To determine the tumor antigen-specific immune response induced by the treatment and to prospectively determine the predictive/prognostic value of pretreatment biological features in identifying patients who will benefit from HDIL-2-based therapy
A single arm Pharmacokinetic/Pharmacodynamic Study of Sunitinib in Patients with Metastasized Renal Cell Carcinoma
Jul 2012Develop PK/PD models for sunitinib including biomarker response (blood pressure, sVEGFR-2, sVEGFR-3) as PD marker
A Three-Part, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Sequential Adaptive, Phase II Study to Evaluate the Safety, Tolerability and Efficacy of OPN305, a Humanised Monoclonal Antibody that Blocks Toll-Like Receptor 2, in Renal Transplant Patients at High Risk of Delayed Graft Function
Jul 2012Primary Objective: • Phase 0: To determine the receptor occupancy of OPN305 1.5mg/kg in patients receiving an ECD, DCD or SCD(CIT>18h) kidney transplantation and to verify the doses of OPN305 to be used in Part A of the study. • Part A: to select the optimal single IV dose of OPN305 for Part B of the study in ECD/DCD/SCD(CIT>18h) kidney transplantation patients. The primary endpoint for this objective is: o The incidence of DGF on Day 7 defined as the need for dialysis in the 7 days post-transplantation (dDGF) in patients receiving an ECD/DCD/SCD(CIT>18h) kidney transplantation • Part B: to extend the evaluation whether the optimal dose of OPN305 from Part A can reduce the incidence of DGF • Parts A and B: to evaluate whether OPN305 can reduce the incidence of DGF defined as the use of dialysis in the 7 days following transplantation (dDGF) o Note that all three active doses may contribute to this endpoint if similar in efficacy in Part A.
Effects of Linagliptin on Renal Endothelium Function in Patients with Type 2 Diabetes.
Jun 2012To determine the effect of linagliptin compared to placebo on basal production and release of nitric oxide (NO) from renal vasculature, as assessed by changes of renal plasma flow due to L-NMMA infusion.
A Phase 2 Assessment of the Diagnostic Accuracy of 99mTc-MIP-1404 Imaging in Men with High-Risk Prostate Cancer Scheduled for Radical Prostatectomy (RP) and Extended Pelvic Lymph Node Dissection (EPLND) Compared to Histopathology
Jun 2012. Assess the ability of 99mTc-MIP-1404 to detect prostate cancer within the prostate gland . Assess the clinical safety of 99mTc-MIP-1404
Study to Observe Safety and Efficacy of Nexavar in Treatment of Kidney Cancer
Jun 2012The objective of this Non-Interventional study is to evaluate the effectiveness & safety of Nexavar in advanced Renal Cell Carcinoma (RCC) patients under daily-life treatment conditions based on age of the patient (older (age >70 years) and younger patients (age <70 years). Specifically investigated are the tumor status, duration of Nexavar ® treatment (number of cycles) and incidence of Hand foot Skin Reaction.
Radium-223 Chloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients with Bone Metastasis
Jun 2012Provide radium-223 chloride to patients diagnosed with CRPC/HRPC with bone metastasis To assess acute and long-term safety of radium-223 chloride
Sympathetic renal denervation versus increment of pharmacological treatment in resistant arterial hypertension
Jun 2012To determine the effect of a percutaneous catheter-based renal sympathetic denervation (RSD) procedure to disrupt renal afferent and efferent nerves using radiofrequency ablation, on 24h ambulatory systolic blood pressure (SBP), in subjects with resistant hypertension (RH), as compared to the addition of spironolactone, an aldosterone receptor blocker, to the baseline pharmacological treatment, from baseline (Visit 0) to Final Examination (Week 24).
Renin-Angiotensin System Quantification in patients treated with Aliskiren or Candesartan (RASQAL)
Jun 2012To demonstrate the quantity of differences in the renin-angiotensin peptide profiles in patients receiving direct renin inhibition or angiotensin receptor blockade.
Oral sodium bicarbonate supplementation in patients with chronic metabolic acidosis and chronic kidney disease
Jun 2012Metabolic acidosis in chronic kidney disease is thought to be the result of an insufficient production of bicarbonate in the renal tubular system. Thus, the intervention of an oral exogenous bicarbonate supplementation to substitute the lacking endogenous bicarbonate seems to be rational. Patients with chronic kidney disease stage III and IV and chronic metabolic acidosis should be randomized to either receive a high dose of oral sodium bicarbonate with a serum target HCO3- level of 24±1 mmol/L or receive a rescue therapy of sodium bicarbonate with a serum target level of 20±1 mmol/L. After two years decline of renal function, as well as mortality rates and time of initiation of renal replacement therapy should be compared across study groups.
Trial of Gemcitabine, Cisplatin, and Ifosfamide in Patients With Relapsed Non-Seminomatous Germ-Cell Tumors
May 2012This is a prospective multicenter phase II trial of gemcitabine, cisplatin, and ifosfamide (GIP) in patients with relapsed non-seminomatous germ-cell tumors (NSGCT) and a predicted favorable prognosis.
A Phase 2 Study of Hsp90 Inhibitor AT13387 Alone or in Combination with Abiraterone Acetate in the Treatment of Castration-Resistant Prostate Cancer (CRPC) no Longer Responding to Abiraterone
May 2012Part A: • To assess the safety and tolerability (incidence and severity of adverse events [AEs]) of the combination of AT13387 and abiraterone acetate and to select the most promising treatment regimen for the combination in subjects with castration-resistant prostate cancer (CRPC) who are no longer responding to treatment with abiraterone acetate alone, based on the overall assessment of safety and antitumor activity. Part B: • To assess and compare the antitumor activity (response rate per the Prostate Cancer Working Group 2 [PCWG2] recommendations) between single-agent AT13387 and the combination of AT13387 plus abiraterone acetate in subjects who are no longer responding to treatment with abiraterone acetate alone.
A Randomized Phase 3 Study Comparing Cabazitaxel/Prednisone in Combination with Custirsen (OGX-011) to Cabazitaxel/Prednisone for Second-Line Chemotherapy in Men with Metastatic Castrate Resistant Prostate Cancer
May 2012To ascertain whether the survival time distribution for patients randomized to the investigational arm is consistent with longer survival as compared to patients randomized to the control arm
A Phase 3, randomized, double-blind, controlled trial of cabozantinib (XL184) vs. mitoxantrone plus prednisone in men with previously treated symptomatic castration-resistant prostate cancer
May 2012The objective of this study is to evaluate the safety and efficacy of cabozantinib compared with mitoxantrone plus prednisone.
A Phase III, Randomized, Multicenter, Double-Blind, Double Dummy, Parallel Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime-Avibactam (CAZ-AVI, formerly CAZ104) Versus Doripenem Followed by Appropriate Oral Therapy in the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis, With a Gram Negative Pathogen in Hospitalized Adults
May 2012To assess the noninferiority of ceftazidime-avibactam compared with doripenem with respect to symptomatic resolution of UTI-specific symptoms and resolution of, or improvement in, flank pain based on the patient-reported symptom assessment
FGFR Inhibition for Epithelial Solid Tumours: a Phase Ib trial of AZD4547 in combination with gemcitabine and cisplatin
May 2012Dose Escalation Cohort: To investigate the safety, tolerability and feasibility of the novel AGC (AZD4547 with gemcitabine and cisplatin) combination in advanced non-haematological malignancies. Randomised Expansion Cohort: To obtain a preliminary indication of the relative toxicities of AGC compared to GC in locally-advanced/metastatic TCC of the urinary bladder (and other urothelial) cancers.
Spironolactone to Prevent Cardiovascular Events in Early Stage Chronic Kidney Disease (CKD): A Pilot Trial
May 2012Patients with reduced kidney function (kidney disease) have high rates of hardening of the blood vessels, which leads to early heart disease and strokes. Previous research has shown that using low dosage of a 'water tablet', spironolactone in patients with early kidney disease in a hospital outpatient setting improved heart structure and function as well as reduced blood vessel stiffness. STOP-CKD study aims to determine if blood vessel stiffness can be safely reduced with the use of low dose spironolactine in people with early stage kidney disease managed at general practices.
A Phase II Study of Axitinib in Patients with Metastatic Renal Cell Cancer Unsuitable for Nephrectomy
May 2012Does treatment with axitinib stop previously untreated widespread kidney cancer that can't be surgically removed from getting worse for at least 6 months?
Efficacy Study of Recombinant Adenovirus for Non Muscle Invasive Bladder Cancer
May 2012The use of a designed viral vector that can destroy cancer cells while leaving normal cells largely unharmed. The virus also stimulates an immunological response by producing a special factor (GM-CSF) to attract and promote the development of dendritic and T effector cells. It forms the hypothesis that this regimen may be used for people who have failed current forms of treatment and are recommended for cystectomy. It is with hope that this novel therapy will be able to delay or potentially avoid cystectomy for this patient population. Bladder instillation of this agent causes little long lasting side effects and may drastically improve the stimulation of the immune system for local cancer cell death as well as destroying those tumor cells that may have travelled to regional lymph nodes or distant organs.
Effects of short-term atorvastatin treatment on prostate cancer - a pre-surgical pilot trial
May 2012Reduction of intraprostatic inflammation and inhibition of prostate cancer growth with short-term atorvastatin treatment.
Pilot Study of BB3 to Improve Renal Function in Patients with Signs and Symptoms of Significant Renal Injury after Kidney Transplantation from Donors after Cardiac Death
Apr 2012The primary objective of this study is to evaluate the safety and efficacy of BB3 compared to placebo in improving renal function in the immediate post-transplant period in patients who have received DCD (Donor after Cardiac Death) kidney transplantation.
Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)
Apr 2012The purpose of this study is to evaluate the effects of Ceftazidime Avibactam compared to Doripenem for treating hospitalized patients with complicated urinary tract infections, including acute pyelonephritis
A Phase III, Randomized, Multicenter, Double-Blind, Double Dummy, Parallel Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime-Avibactam (CAZ-AVI, formerly CAZ104) Versus Doripenem Followed by Appropriate Oral Therapy in the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis, With a Gram Negative Pathogen in Hospitalized Adults
Apr 2012To assess the noninferiority of ceftazidime-avibactam (CAZ-AVI, formerly CAZ104) compared with doripenem with respect to the following coprimary endpoints in the microbiological modified intent-to-treat (mMITT) analysis set: •Symptomatic resolution (or return to premorbid state) of UTI-specific symptoms except flank pain (frequency/urgency/dysuria/suprapubic pain) and resolution of, or improvement in, flank pain based on the patient-reported symptom assessment response at the Day 5 visit •Both per-patient microbiological eradication and symptomatic resolution (or return to premorbid state) of all UTI-specific symptoms (frequency/urgency/dysuria/suprapubic pain/flank pain) based on the patient-reported symptom assessment response at the Test of Cure (TOC) visit
A Phase II, Randomized, Active Comparator-Controlled Clinical Trial to Study the Safety, Tolerability, and Efficacy of MK-7655 + Imipenem/Cilastatin Versus Imipenem/Cilastatin Alone in Patients with Complicated Urinary Tract Infection
Apr 2012To evaluate the efficacy of 2 doses of MK-7655 + imipenem/cilastatin (250 mg and 125 mg) with respect to the microbiological response assessment profile in the treatment of adult patients with cUTI, as compared to imipenem/cilastatin at completion of IV study therapy (DCIV).
A Phase 3bMulticenter, Open-label Abiraterone Acetate Long-term Safety Study
Apr 2012To collect follow-up safety data from patients in completed abiraterone acetate studies. Consideration will be given to extending the duration of the study following review of the safety data at 3 years.
Radiation Induced Cystits treated with Hyperbaric Oxygen. A Randomized controlled Trial
Apr 2012The primary objective of this study is to assess the relief of symptoms after HBO therapy in patients with late radiation cystitis by having EPIC symptom estimation scale as primary variable
A Phase 2, Open-Label, Single-Arm, Multidose Study to Investigate the Effects of Orteronel on the QT/QTc Interval in Patients With Metastatic Castration-Resistant Prostate Cancer
Apr 2012To evaluate the effects of orteronel, when administered with prednisone, on the QT/QTc interval in patients with metastatic castration-resistant prostate cancer (mCRPC)
BEL114424: A Phase 2 Pilot, Single Centre, Randomised, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Belimumab plus Standard of Care versus Placebo plus Standard of Care in the Prevention of Allograft Rejection in Adult Subjects After Renal Transplantation.
Apr 2012The primary objective of this study is to assess the safety and tolerability of belimumab 10 mg/kg (or placebo) administered in addition to standard of care at transplantation (Day 0), Day 14, Day 28 and every 4 weeks through Week 20.
PlasmaKinetic (PK) Button Vaporization Electrode for Treatment of Bladder Tumors
Apr 2012The purpose of this study is to compare the uses of two types of equipment during transurethral resection of bladder tumors (TURBT). The two types of surgical devices are: the monopolar loop electrocautery and the PlasmaKinetic (PK) Button Vaporization Electrode. These two devices do the same task but differ in the way they create electric current when removing cancerous tissue. The investigators hope to examine and compare the uses of these two surgical devices to see if any advantages do exist or whether they actually are similar. The goal of the study will be to prove similarity in outcomes between the two techniques and analyze the outcomes resulting from each case.
An Open-label Study of Sipuleucel-T in European Men with Metastatic, Castrate Resistant Prostate Cancer
Mar 2012The purpose of the study is to demonstrate that sipuleucel-T can be successfully manufactured at a European manufacturing facility. Sipuleucel-T (Provenge®) is approved for use in the US by the Food and Drug Administration for the treatment of metastatic castrate resistant prostate cancer. The study sponsor, Dendreon Corporation is applying for Manufacturing Authorization in Europe. The intent of this study is to demonstrate that sipuleucel-T manufactured in Europe results in the same cellular activation as seen in sipuleucel-T produced in the US.
Pharmacokinetics of micafungin during continuous venovenous hemofiltration
Mar 2012Measuring pharmakokinetecs of micafungin during continuous renal replacement therapy
12 month, multi-center, open-label, prospective, randomized, parallel group study investigating a standard regimen in de novo kidney transplant patients versus a Certican® based regimen either in combination with Cyclosporin A or Tacrolimus
Mar 2012To demonstrate non-inferiority in renal function assessed by glomerular filtration rate (Nankivell formula) in at least one of the Certican® treatment regimens compared to the standard group at month 12 post-transplantation in renal transplant patients.
Study of the Safety and Efficacy of LY2623091 in Chronic Kidney Disease Patients
Mar 2012To investigate the effect of LY2623091 on change from baseline in proteinuria after 3 weeks of daily oral dosing in CKD patients.
Determination of the penetration of antibiotics into epithelial lining fluid during continuous infusion in mechanically ventilated ICU patients: example meropenem
Mar 2012Determination of penetration of IMPs into the epithelial lining fluid in intensive care unit patients
Development and Evaluation of a New Diagnostic Test in Female Urinary Stress Incontinence
Mar 2012The main objective of this study is to compare two prognostic tests in their ability to predict the success (or failure) of the implementation of a suburethral TVT (tension-free vaginal tape) or TOT (trans-obturator tape) treatment for stress urinary incontinence in women. The Q-tip test (test mentioned in the French and international recommendations) is compared to test a new test (clip strip).
TOPARP: Phase II Trial of Olaparib in Patients with Advanced Castration Resistant Prostate Cancer.
Mar 2012The primary objective of this study is to evaluate the activity of olaparib in patients with advanced prostate cancer who have progressed following one or two chemotherapy regimens including docetaxel.
Effects of morning vs evening dosing on the pharmacokinetics and pharmacodynamics of sunitinib.
Mar 2012To determine the influence of morning versus evening administration on the pharmacokinetics of sunitinib and its metabolite
A Phase II, Randomized, Active Comparator-Controlled Clinical Trial to Study the Safety, Tolerability, and Efficacy of MK-7655 + Imipenem/Cilastatin Versus Imipenem/Cilastatin Alone in Patients with Complicated Urinary Tract Infection
Mar 2012To evaluate the efficacy of 2 doses of MK-7655 + imipenem/cilastatin (250 mg and 125 mg) with respect to the microbiological response assessment profile in the treatment of adult patients with cUTI, as compared to imipenem/cilastatin at completion of IV study therapy (DCIV). To evaluate the safety and tolerability profile of 2 doses of MK-7655 + imipenem/cilastatin (250 mg and 125 mg).
A Double blind, Randomized, Placebo-Controlled Study Evaluating the Safety and Effectiveness of Cook MyoSite Incorporated AMDC in Female Patients with Stress Urinary Incontinence
Mar 2012Determine effectiveness and safety of AMDC compared to placebo
Prospective study of 18F-RGD PET-CT in assessment of response to antiangiogenic treatment in patients with renal cancer and comparison with perfusion CT
Feb 2012To evaluate whether changes of uptake on 18F-RGD PET-CT before, during and after anti-angiogenic therapy are associated with tumour response in patients with cancer.
DABIRENAL STUDY A study to investigate the pharmacokinetics and effects of Dabigatran in patients with stable severe chronic kidney disease
Feb 2012To analyze the pharmacokinetics and dynamics of Dabigatran 75 mg twice daily in patients with severe CKD (eGFR 15 - 30 ml/min) until steady state of the drug is established.
Mechanical Nerve Stimulation in the Treatment of Post Prostatectomy Incontinence
Feb 2012The present study aims to treat urinary incontinence in men who are still incontinent more than 1 year after a radical prostatectomy. A medical vibrator is used daily for a period of 6 weeks and the results of the treatment is then evaluated.
A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel group, Adaptive, combined Proof of Concept and Dose-Finding study to investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP3652 in the treatment of female subjects with Bladder Pain Syndrome / Interstitial Cystitis
Feb 2012To investigate efficacy of ASP3652 in female subjects with BPS/IC
Efficacy and safety of liraglutide versus placebo as add-on to existing diabetes medication in subjects with type 2 diabetes and moderate renal impairment
Feb 2012To confirm the superiority of liraglutide versus placebo as add-on to existing oral antidiabetic drug (OAD) and/or insulin therapy on glycaemic control after 26 weeks treatment in subjects with type 2 diabetes and moderate renal impairment
Renal Denervation in Patients With Advanced Heart Failure
Feb 2012Sympathetic system has important role occurrence of symptoms in heart failure. Renal denervation that is ablated some of sympathetic nerves is affected pathology of heart failure. This interventional therapy improves symptoms and life quality.
A Phase II Trial of Combination Cabazitaxel and Cisplatin Chemotherapy in the Neoadjuvant Treatment of Transitional Cell Carcinoma of the Urinary Bladder
Feb 2012To record the proportion of patients whose cancer responds to chemotherapy using the drugs cabazitaxel and cisplatin before surgery in the treatment of transitional cell carcinoma of the urinary bladder. This small study of about 30 patients will help to establish whether this treatment should be studied further in a larger group of patients in future.
Lean Body Mass as a determinant of docetaxel pharmacokinetics and toxicity (LEANDOC)
Feb 2012To determine which anthropometric parameters Lean body mass, total body mass or body surface area correlates best to docetaxel exposure (AUC) .
An open label, multiple dose Phase III clinical study in patients with prostate cancer to investigate the clinical efficacy and safety of a new GnRH implant (AMW Leuprorelin 10.72 mg implant) applied twice every 84 days
Feb 2012Overall objective: to investigate the clinical efficacy and safety of the new GnRH implant (AMW Leuprorelin 10.72 mg implant) applied twice in every 84 days. Primary objective: to demonstrate that AMW Leuprorelin 10.72 mg implant leads to a consistent suppression of testosterone levels below castrate level (0.5 ng/mL).
Single Immediate Instillation of EO9 After TURBT in Patients With Non-muscle-invasive Bladder Cancer (NMIBC)
Feb 2012The purpose of this study is to evaluate the efficacy and safety in patients with non-muscle invasive bladder cancer histologically diagnosed to be stage Ta and G1 or G2 and who were randomized into either an EO9 or placebo group after TURBT.
The effect of aldosterone on the development of chronic allograft nephropathy after kidney transplantation
Feb 2012To examine the possible renal graft protective effects of treatment with eplerenone in kidney transplanted patients in addition to a standard regimen, including studies in the progression of proteinuria and glomerular filtration.
Taste, Smell and Chemotherapy (TASTY)
Jan 2012Taste and smell abnormalities are common in cancer patients undergoing chemotherapy, with a prevalence ranging from 46% to 77% for taste changes, and 35% to 75% for smell changes. These chemosensory changes are distressing for patients and can lead to changes in appetite, food choice, and nutrient intake. These changes can result in malnutrition and weight loss. Possibly, also unhealthy eating patterns can be developed due to these taste and smell changes, given the high prevalence of obesity among survivors of certain cancer types. The primary objective is to investigate the nature, prevalence, and duration of taste and smell changes in patients with disseminated testicular cancer treated with cisplatin based chemotherapy.
Calcitonin stimulation: pentagastrin vs. calcium gluconate - potency, feasibility and tolerance in chronic kidney disease.
Jan 2012Comparison of the two calcitonin stimulation tests pentagastrin and calcium gluconate regarding potency, feasibility and tolerance.
Safety Study of Bipolar Versus Monopolar Transurethral Resection of Bladder Tumors
Jan 2012This is a single-center, prospective, randomized, controlled trial comparing two established transurethral electrical resection methods of urinary bladder tumors regarding their risk of stimulating the obturator nerve.
Efficacy and safety of selective vitamin D receptor activation with paricalcitol for reduction of proteinuria in kidney transplant recipients: a randomized controlled trial
Jan 2012Difference in urinary protein to creatinine ratio (UPCR) between paricalcitol and placebo study group patients.
Comparison of Urine Protein/Creatinine Ratio With 24-hour Urine Protein Excretion in Woman With Hypertensive Disorders
Jan 2012The presence of proteinuria (>300 mg/d) represents an important factor in the diagnosis and evaluation of the pregnant patient with an hypertensive disorder. The 24 hour collection of urine for proteinuria is the gold standard for the diagnosis of the condition and allows the physician to determine if an hypertensive disorder is related directly or not to the gestation. The problem is the time it takes and the technical difficulties related to the sample collection. An alternative is the quantification of protein and creatinine in a random sample of urine. We seek to evaluate if this method is as affective as the gold standard in the diagnosis of proteinuria (>300 mg/d).
A Phase I/II Study of Cabazitaxel Combined with Abiraterone Acetate and Prednisone in Patients with Metastatic Castrate-Resistant Prostate Cancer (CRPC) whose Disease has Progressed after Docetaxel Chemotherapy
Jan 2012To determine the maximum tolerated dose, and dose limiting toxicities of cabazitaxel administered as a 1-hour infusion every 3 weeks in combination with oral daily abiraterone acetate and prednisone in patients with metastatic CRPC To estimate the anti-tumor activity of cabazitaxel in combination with abiraterone acetate and prednisone in terms of PSA response rate
Potentially resectable metastatic colorectal cancer with wild-type KRAS and BRAF: alternating chemotherapy plus cetuximab - A randomised phase II trial - Nordic 7.6
Jan 2012Response rate (RR) estimate by the investigator
an open-label, single-arm, multicenter trial to determine safety and efficacy of eculizumab in the prevention of Antibody Mediated Rejection (AMR) in sensitized recipients of a kidney transplant from a deceased donor
Dec 2011To evaluate the safety and potential efficacy of eculizumab to prevent AMR in sensitized recipients of deceased donor kidney transplants.
A 3-month, multicenter, randomized, open label study to evaluate the impact of early vs delayed introductioN of EVERolimus on WOUND healing in de novo kidney transplant recipients (NEVERWOUND study)
Dec 2011The primary objective of the study is to compare the proportion of patients without wound complications related to initial transplant surgery (i.e. lymphorrea, fluid collections, wound dehiscence, wound infections, incisional hernia) between the delayed everolimus arm and the immediate everolimus arm, between randomization and 3 months after transplantation.
Role of PET/CT with 18F-choline in biochemical relapse in prostate cancer patients treated with radical intent. Pet Col study.
Dec 2011To assess the sensitivity of Pet Ct
A Randomized, Open Label, Multicenter, Phase II, 2-Arm Study comparing the conventional 3 weekly schedule of Jevtana (Cabazitaxel) with a weekly regimen in patients with Metastastic Castration Resistant Prostate Cancer ConWeCab
Dec 2011To determine if a weekly regime improves tolerability of cabazitaxel compared to the standard 3 week regimen
Biological, Pathological and Imagery Markers in the First-Line Treatment of Metastatic Clear-Cell Renal Cell Carcinoma
Dec 2011The aim of this study is to identify and/or validate biomarkers and imaging markers to predict and monitor the activity of a new class of therapeutic agents called antiangiogenics for the treatment of metastatic renal cell carcinoma (mRCC). Suntinib, approved for this indication, will be administred before and after nephrectomy and biomarkers sampling and imaging will be operated to monitor the activity and identify prognostic factors in mRCC.
Adjuvant Versus Progression-Triggered Gemcitabine Monotherapy for Locally Advanced Bladder Cancer
Dec 2011To analyse time to tumor progression in patients cystectomized for locally advanced transitional cell carcinoma (TCC) of the bladder, who are not suitable for cisplatin-based chemotherapy (i.e. postoperative reduced renal function, advanced age). Patients are randomized to receive either adjuvant gemcitabine immediately after radical operation (treatment arm A) or no treatment (control arm B). Patients in the control arm are to be treated with gemcitabine as soon as tumor progression becomes evident clinically and/or radiologically.
Endovascular renal sympathetic denervation versus spironolactone for treatment-resistant hypertension: a randomized, multicentric study
Dec 2011To compare the effect of renal sympathetic denervation with the spironolactone in treatment-resistant hypertension on blood pressure
Clinical trial phase II to determine the feasibility and safety of using autologous mesenchymal stem cells derived from autologous expanded adipose tissue (ASC) in the local treatment of female urinary incontinence due to strain
Dec 2011Evaluate the safety of ASC to treat urinary incontinence in women due to strain.
A Phase III randomised trial of Peri-Operative chemotherapy versus sUrveillance in upper Tract urothelial cancer
Dec 2011Does chemotherapy given around the time of surgery (peri-operative) extend the amount of time for which participants remain free of recurrent disease?
A Phase III randomised trial of Peri-Operative chemotherapy versus sUrveillance in upper Tract urothelial cancer
Dec 2011Does chemotherapy given around the time of surgery (peri-operative) extend the amount of time for which participants remain free of recurrent disease?
A phase IIa study to characterize the effects of CCL2 inhibition with the Spiegelmer® NOX-E36 in patients with type 2 diabetes mellitus and albuminuria.
Dec 2011To characterize the effects of 12 weeks treatment with study drug on albumin-creatinine ratio (ACR) in patients with type 2 diabetes and albuminuria
Open label, single arm, multicenter study to evaluate the safety and immunogenicity of HX575 epoetin alfa in the treatment of anemia associated with chronic kidney disease in pre-dialysis and dialysis patients
Nov 2011To demonstrate the lack of immunogenicity of HX575 administered s.c. in the treatment of anemia associated with CKD
Open label, single arm, multicenter study to evaluate the safety and immunogenicity of HX575 epoetin alfa in the treatment of anemia associated with chronic kidney disease in pre-dialysis and dialysis patients
Nov 2011To demonstrate the lack of immunogenicity of HX575 administered s.c. in the treatment of anemia associated with CKD
A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F ± GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic, Castrate-Resistant Prostate Cancer
Nov 2011To ascertain whether the survival of patients randomized to Arm V+G (PROSTVAC plus GM-CSF) or to Arm V (PROSTVAC) is superior to that from patients randomized to Arm P (placebo control).
Prospective Multicentre Randomized Double-Blind Placebo-Controlled Parallel Group Study on the Efficacy and Tolerability of StroVac® in Patients With Recurrent Symptomatic Bacterial Urinary Tract Infections
Nov 2011To demonstrate the clinical efficacy and tolerability of the inactivated germs of specified enterobacteria contained in StroVac® in recurrent acute uncomplicated symptomatic bacterial urinary tract infections as compared to placebo.
The effects of neoadjuvant hormonal therapy on the course of PSA and testosterone in patients with low and intermediate-risk prostate carcinoma (NEO-ONE); A randomized controlled trial
Nov 2011To assess the effects of 3-month NHT with Eligard 22.5 mg once and Bicalutamide 50 mg daily on the course of PSA in patients treated with BT for low-intermediate risk localized prostate carcinoma
Clinical Value of Homeopathic Prophylaxis of Recurrent Urinary Tract Infections in Persons With Spinal Cord Injury
Nov 2011Recurrent symptomatic urinary tracts infections (UTI) in persons with spinal cord injury are a frequent problem, leading to significant morbidity and to a decreased quality of life. - until today, there is no effective prophylaxis for UTI for patients with spinal cord injury. - homeopathy has been shown to be an effective treatment option in several chronic diseases - study hypothesis: the addition of homeopathic assessment and treatment to a standard prevention strategy for recurrent UTI will significantly reduce the number of symptomatic UTI per year in this group of patients compared to standard prevention alone
A randomised, placebo controlled trial to study the effect of heme-arginate on heme-oxygenase-1 induction and renal function in recipients of deceased donor renal transplants.
Nov 2011Does treating the recipients of deceased donor kidneys with heme-arginate (HA) increase the amount of HO-1 protein in the recipient’s white blood cells compared to placebo treatment?
A randomised, placebo controlled trial to study the effect of heme-arginate on heme-oxygenase-1 induction and renal function in recipients of deceased donor renal transplants.
Nov 2011Does treating the recipients of deceased donor kidneys with heme-arginate (HA) increase the amount of HO-1 protein in the recipient’s white blood cells compared to placebo treatment?
Everolimus in Refractory Testicular Germ Cell Cancer
Oct 2011Everolimus in refractory testicular germ cell cancer. Everolimus 10 mg /day/ is administered to the patient until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements. Feasibility of surgical resection will be assessed after every 2 cycles of the treatment in patients with partial response.
Phase II Study of Weekly Cabazitaxel for Advanced Prostate Cancer in "Unfit" Hormone-Refractory Patients Previously Treated with Docetaxel.
Oct 2011Evaluate the activity of the weekly administration of cabazitaxel as time to PSA progression according to the PCCTWG II criteria.
First Line Pazopanib in Poor Risk Patients with Metastatic Renal Cell Carcinoma
Sep 2011Primary analysis will focus on the rate of poor risk patients as defined by the MSKCC criteria who are free of disease progression at 6 months after start of first line treatment with pazopanib.
A Phase 1/2 Open-Label, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VT-464 in Chemotherapy-Naïve Patients with Castration-Refractory Prostate Cancer
Aug 2011The primary objective of the study is to determine the safety and tolerability of orally-administered VT-464 in chemotherapy-naïve patients with castration-refractory prostate cancer (CRPC).
A 12-week clinical double-blind, randomised study of cholecalciferol versus placebo in patients with chronic kidney disease stage 3-4 (CHICK).
Aug 2011To investigate whether there is a difference in the mean change from baseline of the blood levels of parathyroid hormone (PTH) between patients receiving cholecalciferol compared with patients receiving cholecalciferol placebo after 12 weeks’ treatment.
An Open-Label, Multi-Centre, Extension Study, Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Patients with Prostate Cancer Requiring Androgen Ablation Therapy
Aug 2011To evaluate safety and tolerability during long-term treatment with degarelix one-month dosing regimen in prostate cancer patients
Analysis of Foxp3 and Vimentin Expression in Renal Transplant Recipient (TUFEV)
Aug 2011This observational study is designed to analyse the urinary mRNA expression of Foxp3 and Vimentin, two genes involved in tolerance and early graft dysfunction in 500 renal transplant recipients from 17 renal transplant site in France and to determine the predictive value of these gene expression on the one year graft outcome including graft function, one-year graft histological analysis and incidence of acute rejection.
A phase II study in mCRPC on the pharmacodynamic effects of budesonide on cabazitaxel (Jevtana®): A randomised, open-label multicenter study: CABARESC
Aug 2011To study the effects of budesonide on the incidence of cabazitaxel induced diarrhea
An open label, one-arm, multiple dose study in patients with prostate cancer to demonstrate efficacy of a one month goserelin 3.6 mg implant in a two months treatment (2 application periods) and PK/PD analysis of Zoladex® 3.6 mg implant in additional 12 patients.
Aug 2011To demonstrate that Acino Goserelin 3.6 mg implant is effective in achieving and maintaining castration levels of testosterone.
Testosterone Replacement in Young Male cancer Survivors
Aug 2011The principal research question is to find out whether testosterone replacement therapy can reduce body fat and improve quality of life in young male cancer survivors who have a borderline low level of testosterone.
Association Between Hepatitis C Infection and Renal Cell Carcinoma
Jul 2011The purpose of this study is to determine if there is an association between hepatitis C infection and kidney cancer. All patients who are diagnosed with kidney cancer and who will either have a biopsy or surgery will be offered to be tested for hepatitis C. The control group will be colon cancer patients. Both groups would be of recent diagnosis (6 months).
Detection of non-muscle invasive bladder cancer using PVP-Hypericin (Vidon®) fluorescence cystoscopy (Hypericin PDD)
Jul 2011To collect preliminary data on the diagnostic performance of Hypericin-guided cystoscopy regarding the detection of non-muscle invasive bladder cancer . Standard, white light cystoscopy will be compared with Hypericin assisted cystoscopy (PVP-Hypericin instillation; white light followed by blue light (Hypericin PDD)) using a within-patient design by inspecting the bladder under white light first, followed by blue light.
An open, multicenter study to evaluate the urodynamic properties of a local implantation of autologous skeletal muscle-derived cells (SMDCs) in female patients with stress urinary incontinence
Jul 2011The objective of this study is to evaluate the functional status of the urethra and particularly the urethral rhabdosphincter by means of urodynamic measures after SMDCs implantation procedure in female patients with SUI.
A trial of Prostate Radiotherapy in Conjunction with Carbogen and Nicotinamide (PROCON)
Jun 2011We propose a study to test whether it is possible to improve the outcome of prostate radiotherapy using simple, cost-effective measures. Carbogen gas (98% oxygen and 2% carbon dioxide) and nicotinamide (vitamin B3) will be given in conjunction with standard prostate radiotherapy. Disease control, survival and toxicity will be measured. The study aims to determine the efficacy of carbogen gas breathing and nicotinamide tablets, given during a course of intensity-modulated radiotherapy to the prostate gland in previously untreated patients with prostate cancer.
MR Image Guided Therapy in Prostate Cancer
Jun 2011To test the safety and effectiveness of treating prostate tumors with laser therapy guided by magnetic resonance imaging.
A pilot, explorative study to identify contrast-enhanced ultrasound (CE-US) patterns that characterize acute allograft rejection and other causes of acute allograft dysfunction in renal transplant recipients
Jun 2011To identify the patterns of kidney graft perfusion that are associated with key patterns of renal involvement that may be detected in patients with acute allograft dysfunction.
Outcome Assessment of an Active Surveillance Program for Low Risk Prostate Cancer: An Observational Study
Jun 2011The purpose of this observational study is to prospectively monitor the outcome associated with men who meet the eligibility criteria for low risk prostate cancer and elected to participate in the active surveillance program at The Center for Cancer Prevention and Treatment at St. Joseph Hospital.
Prevalence of Aspirin Resistance in Chronic Kidney Disease Patients
May 2011The primary objective of the study is to determine the prevalence of aspirin resistance in chronic kidney disease patients. The secondary objectives are to determine possible risk factors contributing to aspirin resistance in this population.
Randomized, Open Label, Multi-Center Study comparing Cabazitaxel at 25 mg/m2 and at 20 mg/m² in Combination with Prednisone Every 3 Weeks to Docetaxel in Combination with Prednisone in Patients with Metastatic Castration Resistant Prostate Cancer not Pretreated with Chemotherapy
May 2011To demonstrate the superiority of cabazitaxel plus prednisone at 25 mg/m² (Arm A) or 20 mg/m² (Arm B) versus docetaxel plus prednisone (Arm C) in term of overall survival (OS) in patients with metastatic castration resistant prostate cancer (MCRPC) and not previously treated with chemotherapy
A Prospective, Randomized, Double-Blind, Multicenter Study to Establish the Safety and Tolerability of Doripenem Compared With Cefepime in Hospitalized Children With Complicated Urinary Tract Infections
May 2011The primary objective of this study is to establish the safety and tolerability profile of doripenem compared with that of cefepime in hospitalized children 3 months to <18 years of age with cUTI (complicated Urinary Tract Infection).
The Effect of Remote Postconditioning on Graft Function in Patients Undergoing Living-related Kidney Transplantation
May 2011The purpose of this study is to investigate whether upper limb ischemic postconditioning can improve renal function and decrease ischemic-reperfusion injury in patients undergoing living donor kidney transplantation.
An open-label, multicenter Phase Ib/2 study of E7080 alone, and in combination with everolimus in subjects with unresectable advanced or metastatic renal cell carcinoma following one prior VEGF-targeted treatment.
Apr 2011Phase Ib: To determine the dose limiting toxicities and maximally tolerated dose and establish the recommended phase 2 (RP2) dose for E7080 incombination with everolimus in subjects with unresectable advanced or metastatic renal cell carcinoma (RCC). Phase 2: To compare the progression free survival of 1) E7080 in combination with everolimus at the RP2 dose once daily (Arm A) and 2) single agent E7080 24 mg once daily (Arm B) to single agent everolimus 10 mg once daily (Arm C) in subjects with unresectable advanced or metastatic RCC and disease progression following one prior VEGF targeted treatment.
SAPROCAN: Saracatinib (AZD0530) and docetaxel in metastatic, castrate-refractory prostate cancer: a phase I/randomised phase II study by the UK NCRI Prostate Clinical Studies Group
Mar 2011For the first part of the study (phase I), the primary objective is to find a safe and tolerable dose for saracatinib (AZD0530) given in combination with standard chemotherapy treatment (docetaxel and prednisolone) for patients with metastic castrate-refractory prostate cancer. For the second part of the study (phase II), the primary objective is to investigate whether we can improve the benefits of chemotherapy cancer treatment for patients with metastic castrate-refractory prostate cancer by adding a new drug, saracatinib (AZD0530).
Multimodal Rehabilitation Program to Bladder Cancer Patients (MRPBC)
Mar 2011The aim of the study is to investigate the efficacy of a multiprofessional rehabilitation programme for patients with invasive bladder cancer referred to surgery.
Efficacy and Safety Study of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance. (PCM301)
Mar 2011To assess the impact of TOOKAD® Soluble-Vascular Targeted Photodynamic Therapy (VTP) on the rate of absence of definite cancer using patients on active surveillance as a comparison (co-primary objective A) and to determine the difference in rate of treatment failure associated with observed progression of disease from low risk prostate cancer to moderate or higher risk prostate cancer in men who undergo TOOKAD® Soluble-VTP compared to men on active surveillance (co-primary objective B).
A multicenter, double-blind, randomized, phase 3 study to compare the safety and efficacy of intravenous CXA 201 and intravenous Levofloxacin in complicated Urinary Tract Infection, including Pyelonephritis
Feb 2011To demonstrate the non-inferiority of CXA-201 versus comparator (levofloxacin) in adult subjects with cUTI (including pyelonephritis) based on the difference in composite microbiological eradication and clinical cure rate in the mMITT population at the test-of-cure (TOC) visit (7 days [± 2 days] after last treatment) (CXA-201 minus comparator [levofloxacin]), using a non inferiority margin of 10%.
A phase 2, open-label, single-arm, efficacy and safety study of MDV3100 in patients with hormone-naïve prostate cancer
Feb 2011To evaluate the effect of MDV3100 on prostate-specific antigen (PSA)
Ferumoxytol Enhanced MRI for the Detection of Lymph Node Involvement in Prostate Cancer
Feb 2011To evaluate the safety and effectiveness of Ferumoxytol as a contrast agent in individuals who are scheduled to have prostate removal surgery to treat prostate cancer.
A phase I/II multicentric Belgian prospective novel sequential chemo-immunotherapy regimen for adjuvant treatment in non-muscle invasive bladder cancer.
Feb 2011The purpose of this trial is to evaluate the toxicity for intermediate and high risk NMIBC, after complete transurethral resection of all papillary tumours, of an intravesical sequential treatment combining MMC (mitomycine c) 40mg and BCG (Bacillus Calmette-Guérin) 1/10th , 1/6th and 1/4 dose. MMC will act as an apoptosis inductor and BCG as a recruiter of immune effectors, among which DCs. We then hope to obtain, in addition to the classical response to MMC, an immune response with a presentation of TAA in association with MHC class I able to induce a specific CTL-mediated response directed against the tumour. The study is designed to evaluate the safety and severity of acute side effects of the treatment.
Effect of Remote Ischaemic Preconditioning on Renal Function in Patients Undergoing Living Donor Kidney Transplantation
Feb 2011The purpose of this study was to investigate whether lower limb ischaemic preconditioning can improve renal function in patients undergoing living donor kidney transplantation
A Randomized, Double-Masked, Placebo-Controlled, Multicenter, Phase 2 Study to Evaluate the Safety and Renal Efficacy of LY2382770 in Patients with Diabetic Kidney Disease due to Type 1 or Type 2 Diabetes
Jan 2011Primary objective is to determine if LY2382770, administered monthly for 1 year is more effective than placebo at slowing the progression of diabetic kidney disease in patients treated with angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARB)
Investigation of pathways regulating cell survival and early antiangiogenic response to single agent Rapamycin in Renal Cancer
Jan 2011Drugs that inhibit the mTOR enzyme have clinical activity in renal cancer, causing significant delay in disease progression, although with a low incidence of objective tumour regressions. This trial aims to identify early indicators of disease response or resistance.
A randomized, controlled Phase III study investigating IMA901 multipeptide cancer vaccine in patients receiving sunitinib as first-line therapy for advanced/metastatic renal cell carcinoma
Jan 2011The primary objective of the present phase III study is to investigate whether IMA901 can prolong overall survival in patients with metastatic and/or locally advanced renal cell carcinoma (RCC) when added to standard first-line therapy with sunitinib
A multicenter, randomized, double-blinded, parallel-group, placebocontrolled study to assess the efficacy and safety of skeletal muscle-derived cell implantation in female patients with stress urinary incontinence
Dec 2010The main objective is to show superiority of skeletal muscle-derived cells (SMDCs) over placebo in female patients with SUI
Does phosphate binding with sevelamer carbonate improve cardiovascular structure and function in patients with early chronic kidney disease?
Dec 2010Reduction of left ventricular mass by reducing dietary phosphate intake with sevelamer carbonate.
Everolimus for Patients With Relapsed/Refractory Germ Cell Cancer (RADIT)
Nov 2010The purpose of this study is to determine whether the drug everolimus is effective in the treatment of patients with relapsed cancer of the testis.
Radiotherapy and Androgen Deprivation in Combination After Local Surgery. A randomised controlled trial for patients with prostate cancer.
Nov 2010To test whether adjuvant tratment with radiotherapy following radical postatectomy leads to better outcomes than regular observation with early salvage treatment given at the tune of a rising PSA - Radiotherapy Timing Randomisation.
Effect of N-acetylcysteine on hydrogen sulfide in chronic kidney disease
Nov 2010The main objectives of the trial are to investigate the effect of NAC on plasma H2S levels. Secondly to investigate differences in plasma H2S levels between healthy volunteers, CKD patients, and dialysis patients.
Phase III Randomized Study of Standard Versus Extended Pelvic Lymphadenectomy During Radical Cystectomy in Patients With Muscle-Invasive Urothelial Carcinoma of the Bladder
Oct 2010To compare disease-free survival (DFS) of patients with muscle-invasive urothelial carcinoma of the bladder undergoing radical cystectomy with extended pelvic lymph node dissection (PLND) or standard pelvic lymphadenectomy.
A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel (TAK 700) Plus Prednisone With Placebo Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer That Has Progressed During or Following Docetaxel-based Therapy
Oct 2010To determine if orteronel plus prednisone improves overall survival (OS)
Multicentre, single-arm, open label clinical trial intended to provide early access to cabazitaxel in patients with metastatic hormone refractory prostate cancer previously treated with a docetaxel-containing regimen and to document safety of cabazitaxel in these patients
Oct 2010To allow patients similar to those evaluated in the TROPIC trial, and Investigators access to cabazitaxel for the management of metastatic Hormone Refractory Prostate Cancer (mHRPC) in patients who have progressed during or after docetaxel, and to document the overall safety of cabazitaxel in these patients.
A prospective open-label randomized study to determine the effects of intravenous Iron administration on markers of kidney injury in chronic kidney disease (CKD)
Oct 2010To assess whether two preparations of intravenous iron therapy affect markers of kidney injury including NGAL levels in serum and urine as a result of intravenous Iron therapy in patients with chronic kidney disease (CKD). The primary objectives of this study are to: To assess the effects of two preparations of intravenous (IV) iron in a cohort of CKD patients with biochemical functional or absolute iron deficiency (ferritin level less than 200 g/l or/and transferrin saturation of <20%) on measures renal injury. To determine whether iron sucrose and iron dextran differ in their effects on markers of renal injury in comparison to baseline measures during the lead in period. To determine whether IVI iron leads to potential transient AKI from assessment of changes in markers of renal injury from baseline markers prior to iron administration.
A randomized, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of pazopanib as adjuvant therapy for subjects with localized or locally advanced RCC following nephrectomy
Oct 2010To evaluate disease-free survival (DFS) with pazopanib (800 mg/day for 1-year) as compared to placebo as adjuvant therapy for subjects with localized/locally advanced RCC following nephrectomy.
A Randomized Phase II Study of Afinitor (RAD001) vs. Sutent (Sunitinib) in Patients with Metastatic Non-Clear Cell Renal Cell Carcinoma (ASPEN)
Oct 2010The primary endpoint will be a comparison of progression-free survival (PFS) between the treatment arms following therapy initiation. Disease progression is defined by documentation of progressive disease, a new primary malignancy, or death (whichever occurs first), censored at the last tumor evaluation date.
A phase II study of pazopanib in patients with metastatic or unresectable renal cell carcinoma (RCC) who have failed prior sunitinib therapy
Oct 2010The primary objective of this trial is to assess Progression free survival at 4 months. Progression Free Survival is defined as the length of time between the date of starting treatment and the earliest date of disease progression or death due to any cause.
Single center, open-label, cross-over study in maintenace kidney allograft recipients to evaluate the bioavailability of CellCept® (Mycophenolate mofetil) in comparison to Myfortic® (Enteric- coated mycophenolate sodium) in combination with a proton pump inhibitor without co-medication.
Oct 2010The objective of this pharmacokinetic trial is to analyze, whether the concomitant administration of a proton pump inhibitor influences the bioavailability of mycophenolic acid, applied as either mycophenolat mofetil or enteric-coated mycophenolic acid.
A Risk Based Approach to Improving Chronic Kidney Disease Management
Sep 2010Aim 1: To assess whether quality of care for stage 3 chronic kidney disease can be substantially improved over 18 months by: Point of care electronic alerts to primary care physicians recommending risk-appropriate care, and Quarterly mailings to patients providing self management support materials, including tailored recommendations based on personalized data from an electronic disease registry. Aim 2: To assess the relationship between utilization of the intervention components and primary care physician attitudes towards both chronic kidney disease management and electronic reminder systems.
Standard Surgery or Minimal-Access Surgery in Treating Patients With Bladder Cancer
Sep 2010This randomized phase II trial is studying standard surgery to see how well it works compared with minimal-access surgery in treating patients with bladder cancer.
A European randomised Phase 3 study to assess the efficacy and safety of TOOKAD® Soluble for localised prostate cancer compared to Active Surveillance
Aug 2010To assess the impact of TOOKAD® Soluble VTP on the rate of absence of definite cancer using patients on active surveillance as a comparison (co-primary objective A) and to determine the difference in risk of treatment failure associated with observed histological progression of disease in men with low risk prostate cancer who undergo TOOKAD® Soluble VTP compared to men on active surveillance (co-primary objective B).
Randomized, Double-Blind, Phase 3 Trial to Compare the Efficacy of Ipilimumab vs Placebo in Asymptomatic or Minimally Symptomatic Patients with Metastatic Chemotherapy-Naïve Castration Resistant Prostate Cancer. Revised Protocol Number 01 incorporating Administrative Letters 01 and 02 and Amendment 05 + Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (version 3.0 dated 11-Jan-10) + Immune Monitoring Amendment 04 (version 1.0 dated 18-Mar-11)-Site Specific
Aug 2010To compare overall survival of subjects with chemotherapy-naïve Castration Resistant Prostate Cancer (CRPC) who have been randomized to ipilimumab vs placebo.
Comparison Study of Narrow Band Imaging Versus White Lite Resection in Patients With Bladder Tumors/Cancer
Aug 2010The purpose of this study is to compare the recurrence rate at 1 year following Narrow Band Imaging and trans-urethral resection of bladder tumor with White Light and TURB in patients with non-muscle invasive bladder cancer.
Nebivolol Effect on Nitric Oxide Levels, Blood Pressure, and Renal Function in Kidney Transplant Patients
Jul 2010This study will investigate the blood pressure lowering efficacy of nebivolol among renal transplant recipients who are on calcineurin inhibitors which are believed to contribute to hypertension by SNS activation and decreased prostaglandin and nitric oxide production. Hypotheses: Nebivolol is more beneficial than metoprolol in favorably affecting markers of oxidative stress in hypertensive renal transplant patients. Nebivolol has a better impact than metoprolol on kidney function among hypertensive renal transplant patients
Effects of an Exercise Program in Patients With Hypertensive Chronic Kidney Disease
Jun 2010This study aims to determine the effect of exercise in patients with CKD not yet on dialysis.
PET Acetate for Castrate-Resistant Prostate Cancer on Chemotherapy
Jun 2010One purpose of this research study is to examine if a special type of imaging test, a positron emission tomography (PET) scan using the radioactive material [C-11] acetate, will be helpful in detecting prostate cancer lesions in subjects with castrate-resistant prostate cancer.
Impact of Rituximab Induction and Living Donation on Immunoregulation and Virus Control in Renal Transplantation
Jun 2010This project comprises immunological and virological analyses within a prospective clinical study of Rituximab (Rtx)-treated blood group incompatible living donor (LD) renal transplant recipients compared to blood group compatible LD recipients without Rtx induction, and of living donor compared to deceased donor renal transplant recipients treated with tacrolimus (Tacr)/mycophenolate sodium (MPS). Aim of this project is to assess short- and long-term effects of immunosuppressive therapy (Rtx induction) and of living donation on immunological and histological parameters of graft outcome and on viral replication (BK, JC, CMV, EBV) with the potential to improve long-term graft outcome and to enable risk estimation of virus disease.
A Phase II Study of Bevacizumab and Erlotinib in Subjects With Advanced Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC) or Sporadic Papillary Renal Cell Cancer
May 2010To determine the effectiveness of the combination of bevacizumab and erlotinib as a treatment for patients with (1) metastatic HLRCC kidney cancer and (2) metastatic kidney cancer not associated with HLRCC (or sporadic papillary RCC).
Phase II trial evaluating combined image guided radiotherapy with Panitumumab (Vectibix®) in patients with muscle invasive transitional cell carcinoma of the bladder
May 2010Primary objective is to evaluate the safety of combined radiotherapy with Panitumumab in bladder preservation in invasive bladder cancer.
Velcade and Sorafenib in Unresected or Metastatic Renal Cell Carcinoma
Apr 2010The primary objective of this study is to investigate the efficacy of combination of sorafenib and VELCADE® (bortezomib).
A Proof of Concept, Phase 2a, Double-blind, Parallel Group, Randomised, Placebo controlled Study to Assess the Effect of Lanthanum Carbonate on intact FGF23 in Normo-phosphataemic Subjects with Stage 3 Chronic Kidney Disease
Mar 2010A Proof of Concept, Phase 2a, Double-blind, Parallel Group, Randomised, Placebo controlled Study to Assess the Effect of Lanthanum Carbonate on intact FGF23 in Normo-phosphataemic Subjects with Stage 3 Chronic Kidney Disease
A randomized trial of Rituximab in induction therapy for living donor renal transplantation
Mar 2010Can the addition of rituximab to a minimalist immunosuppressive regimen allow further reduction in immunosuppression?
Multicenter phase 2 trial of arq 197 for subjects with relapsed or refractory germ cell tumors
Mar 2010The primary objective is to determine the objective response rate (ORR) after 4 cycles of therapy with ARQ 197 in subjects with GCT.
Single site, phase II, double blind, randomised, placebo controlled study of the effect of dutasteride (Avodart)0.5 mg on the volume and characteristics of prostate cancer, as assessed by multifunctional magnetic resonance imaging (MRI) in a low risk prostate cancer population
Mar 2010In men with low risk prostate cancer, who seek to adopt expectant management (active surveillance or deferred radical therapy)does exposure to 0.5mg dutasteride once daily for six months result in a change in volume of prostate cancer, as assessed by MRI (T2 weighted)?
Study of the Efficacy of Maintenance Therapy Using Uracil-tegafur (UFT) or Bacille Calmette-Guerin (BCG) for the Prevention of Recurrences of Superficial Bladder Cancer (EMBARK Study)
Mar 2010The purpose of this prospective randomized controlled study is to prove the non-inferiority of UFT maintenance therapy to BCG maintenance therapy for preventing recurrences of superficial bladder cancer.
Study to Evaluate the Effect of Zemplar on Cardiac Morbidity in Patients With Chronic Kidney Disease (CKD) Stage 5 Over 2 Years
Feb 2010Hypercalcemia is a well - known factor for cardiac disease. No data are available in Austria for a cohort with cardiac disease treated with Zemplar (Paricalcitol I.V.)
Dalteparin in Combination With Sunitinib in Patients With Metastatic Kidney Cancer
Feb 2010To determine the recommended dosage of Sunitinib and Dalteparin in patients with metastatic renal cell cancer. To evaluate the safety and tolerability of combination of Sunitinib and Dalteparin.
Weight Loss Interventions in Obese Patients With Stages 3-4 Chronic Kidney Disease: a Randomised Controlled Trial
Jan 2010This randomised trial will allocate patients to either lifestyle modification with diet, exercise and pharmacotherapy, or weight loss surgery to remove two thirds of the stomach using the laparoscopic sleeve gastrectomy procedure. This study aims to evaluate weight loss surgery vs lifestyle modification in patients with chronic kidney disease with estimated kidney function of 20-60% and morbid obesity (BMI 35-45) in terms of kidney function, cardiovascular disease risk factors and all-cause mortality.
A Safety Study of LBH589 (Panobinostat) and RAD001 (Everolimus) to Stabilize Kidney Cancer
Dec 2009This study will see how these two commonly used treatments (Everolimus and Panobinostat) work together in treating kidney cancer
Eculizumab to Enable Renal Transplantation in Patients With History of Catastrophic Antiphospholipid Antibody Syndrome
Dec 2009In this trial, a drug called eculizumab will be tested for its ability to prevent CAPS after kidney transplantation in patients with a prior history of CAPS. Eculizumab is an inhibitor of the complement system, which is believed to be important in generating the inflammatory environment that leads to diffuse clotting of blood vessels in CAPS.
Prospective multicentric evaluation of a bladder preservation strategy using a combination of neoadjuvant chemotherapy with intensified MVAC (Méthotrexate + vinblastine + adriamicine + Cisplatine) and optimal bladder transurethral resection in patients with a localized muscle infiltrative urothelial carcinoma (protocol ReChiVe)
Nov 2009The 5 years bladder preservation rate in patients with a localized infiltrative bladder treated with a double optimal transurethral bladder resection (TURB) combined with a neoadjuvant chemotherapy.
A Phase I Study of Intravenous Recombinant Human IL-15 in Adults With Refractory Metastatic Malignant Melanoma and Metastatic Renal Cell Cancer
Nov 2009•To determine whether rhIL-15 is safe and effective in the treatment of metastatic malignant melanoma or metastatic renal cell carcinoma •To examine how the body processes rhIL-15 after each infusion and determine how it acts on the treated cancer.
An Open-label, Multicentre, Randomised, 3-arm Study to Investigate the Comparative Efficacy and Safety of Intravenous Ferric Carboxymaltose (Ferinject® High- and Low-dosage Regimens) versus Oral Iron for the Treatment of Iron Deficiency Anaemia in Subjects with Non-dialysis-dependent Chronic Kidney Disease
Nov 2009To evaluate the long-term efficacy of FCM (using targeted ferritin levels to determine dosing) or oral iron to delay and/or reduce erythropoiesis stimulating agent (ESA) use and/or other anaemia management options in NDD-CKD subjects with iron deficiency anaemia (IDA).
PROstaTE Cancer Treatment and Obesity in Zoladex-Astrazeneca Treated Patients (PROTECT-Z)
Nov 2009to assess percentage recurrence rate among normal weight and overweight or obese prostate cancer patients treated by adjuvant Zoladex therapy.
Impact of Adherence to Anemia Management Policy on Repeat Hospitalization in End Stage Renal Disease (ESRD)
Nov 2009The investigators hypothesize that the post-hospitalized patient status is characterized by subacute and reversible metabolic and hematological changes that, if addressed and treated in a timely manner, would result in a reduced risk for repeat hospitalization. Consequently, a structured quality improvement program, focused on increasing adherence to company wide anemia management policies (ie hemoglobin monitoring within the first 3-5 days post-hospitalization, followed by an appropriate EPO dose modification within the 7 days post-hospitalization), will significantly decrease the risk of hospital re-admission in the 30 days after discharge.
Safety and Efficacy of Paricalcitol Capsules in Decreasing Serum Parathyroid Hormone Levels in Children 10-16 With Chronic Kidney Disease (CKD).
Nov 2009Safety and efficacy study using Paricalcitol capsules to decrease parathyroid hormone levels in children ages 10-16 with Chronic Kidney Disease.
Studying Genes, Environment, and Prostate Cancer Risk in Patients With or Without Prostate Cancer and Their First-Degree Relatives
Nov 2009This clinical trial is studying genes, environment, and prostate cancer risk in patients with or without prostate cancer and their first-degree relatives.
Open-label, randomised multicentre study of CAMPATH-1H versus basiliximab induction treatment and sirolimus versus tacrolimus maintenance treatment for the preservation of renal function in patients receiving kidney transplants
Nov 2009The primary aims of the 3C Study are to investigate, in people receiving a kidney transplant, whether: 1) using Campath-1H as induction therapy (i.e. given around the time of transplant surgery) reduces the incidence of acute rejection of the kidney transplant at 6 months after surgery, compared to standard basiliximab-based induction therapy; and 2) whether sirolimus-based maintenance immunosuppression (i.e. the drugs they have to take every day to prevent their body's immune system from attacking ('rejecting') the transplant) improves the function of their kidney transplant, compared to using tacrolimus-based maintenance therapy at 2 years after transplantation.
Radiation Therapy Compared With Chemotherapy in Treating Patients With Stage I Testicular Cancer
Nov 2009Randomized phase III trial to compare the effectiveness of carboplatin with that of radiation therapy in treating patients who have stage I testicular cancer.
ONCOFID-P (Paclitaxel-hyaluronic acid) in the intravesical therapy of patients with non-muscle invasive cancer of the bladder. A phase II marker lesion study
Oct 2009To assess, at control visit (V8), the ablative activity of intravesical administration of Oncofid-P-B on a papillary marker tumor on patients suffering from multiple recurrent Ta G1-G2 papillary cancer of the bladder after 6 weeks of weekly study drug administration, through number and percentage of patients with Complete Response.
Exploratory study of besipirdine efficacy and safety in male patients with persistent stress urinary incontinence after radical prostatectomy
Oct 2009To assess the clinical efficacy of besipirdine (20 mg b.i.d.) compared to placebo in male patients with persistent stress urinary incontinence further to radical prostatectomy
Vitamin D in addition to RAAS blockade and dietary sodium for the Treatment of Urinary Excretion of albumin: the ViRTUE-study
Oct 2009Does paricalcitol have an additive antiproteinuric respons to RAAS blockade and low sodium diet?
Skeletal muscle-derived cell implantation in female patients with stress urinary incontinence: a multicenter, randomized, parallel-group, placebo-controlled clinical study
Sep 2009The objective of this study is to find the optimal cell count for functional regeneration of the urethral sphincter, including safety evaluation.
Immunogenicity and Safety of HEPLISAV™ Hepatitis B Virus Vaccine in Chronic Kidney Disease (CKD) Patients
Sep 2009The purpose of the study is to explore the safety and immunogenicity of a new investigational hepatitis B virus vaccine, HEPLISAV™, in patients 18 to 75 years of age who have progressive loss of kidney function.
Prostate Cancer Symptom Management for Low Literacy Men
Sep 2009This study will compare a newly-developed patient education program to help men with localized prostate cancer manage treatment-related side-effects versus usual care.
A single group trial evaluating one cycle of adjuvant BEP chemotherapy in high risk, stage 1 non-seminomatous germ cell tumours of the testis (NSGCTT)
Sep 2009To show that one cycle of adjuvant BEP chemotherapy results in a 2 year recurrence rate of less than 5% in patients with high-risk stage 1 NSGCTT
Pilot study of Lapatinib (Tyverb®) in néoadjuvant treatment for patients with locally bladder carcinoma before cystectomy
Sep 2009The primary objective of the study is to evaluate the effect at a molecular level, of 3 weeks of neoadjuvant lapatinib, in locally advanced muscle-invasive transitional cell carcinoma of the bladder. A comparison of tissue from the original biopsy and cystectomy after lapatinib will allow this to occur. This effect will be evaluated by studying proliferation and apoptotic markers as well as the phosphorylation of proteins which are components of the egf signalling pathway.
Impact of F-18-Fluorocholine PET/CT and MR Imaging/ Spectroscopy in the Management of Primary and Recurrent Prostate Cancer
Aug 2009The purpose of this study is: To evaluate the utility of F-18-FCH-PET/CT and MR imaging with 3-D MR spectroscopy in detecting, localizing, and estimating the volume of initial primary prostate cancer as compared to the current standard work-up using TRUS-guided biopsy. All imaging findings will be correlated with "gold standard" step slice histological examination. The hypothesis is that the combination of noninvasive imaging will improve the preoperative work-up as compared to the current approach. To evaluate FCH-PET for the restaging of prostate cancer after biochemical relapse in a large patient cohort. This will run in parallel to the work-up of primary prostate cancer, as the FCH radiopharmaceutical will be available during the time of study at absolutely no cost to patients or CHUV. A number of studies have demonstrated the benefits of F-18-FCH-PET/CT for these patients and this indication is currently not reimbursed by Swiss obligatory health insurance providers.
Phase II/III Randomized Study of Lapatinib Ditosylate in Patients With HER1- and/or HER2-Overexpressing Stage IV Transitional Cell Carcinoma of the Bladder
Jul 2009Compare progression-free survival in patients with HER1- and/or HER2-overexpressing stage IV bladder cancer who have been randomized to maintenance therapy with lapatinib ditosylate or placebo following first-line chemotherapy.
Chronic Kidney Disease Antidepressant Sertraline Trial (CAST)
Jul 2009This is a randomized double-blinded placebo-controlled trial to see if treatment with sertraline as compared with placebo tablets will improve depression symptoms in patients with chronic kidney disease who have not yet started dialysis or received a kidney transplant. The investigators will also investigate whether sertraline treatment will improve quality of life and whether it is safe to use in patients with kidney disease. The study subject will be randomly assigned to take either sertraline or a placebo tablet for 12 weeks.
A Randomized, Double-Blind, Phase 3 Trial Comparing Ipilimumab vs. Placebo Following Radiotherapy in Subjects with Castration Resistant Prostate Cancer That Have Received Prior Treatment with Docetaxel. Revised Protocol 05 incorporating Protocol Amendments 04, 09, 11,12 and 14 + Biomarker Amendment 06 (version 1.0 dated 16-Nov-09) - Site Specific + Serum Biomarker Amendment 13 (Version 1.0 dated 18-Mar-11) - Site Specific
Jul 2009To compare overall survival of subjects with castration resistant prostate cancer (CRPC), that have progressed during or following docetaxel treatment, when randomized to treatment with bone-directed radiotherapy followed by ipilimumab vs bone-directed radiotherapy followed by placebo.
Management of children following acute pyelonefritis or recurrent urinary tract infection episodes and prevention of renal scarring: a prospective randomised controlled clinical trial.
Jul 2009To identify the best management to reduce renal damage in patients with APN and UTI and to improve their quality of life.
Using Sitagliptin as a Treatment to Prevent New Onset Diabetes After Kidney Transplantation
Jun 2009This study is designed to see if the use of the drug Sitagliptin (used to reduce insulin resistance) will delay or prevent kidney transplant patients from getting diabetes.
Serum CA9 Level as Biological Marker of the Treatment Response in Metastatic Renal Cell Cancer (CA9CRM)
Jun 2009The gene encoding an oncoprotein called indifferently membrane antigen MN, MN/CA9 isoenzyme, carbonic anhydrase IX CA9, G250/MN/CA9 or protein G250. It was demonstrated that the level of expression of CA9 in tumor tissue can be used as a predictive marker of response to immunotherapy. The investigators have developed the ELISA and quantitative reat time polymerase chain reaction (RT-PCR) to study the CA9 protein and CA9 mRNA in the serum of patients with non-metastatic kidney cancer.
A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Tolerability of Oral Tonapofylline in Patients with Heart Failure and Renal Insufficiency
Jun 2009The primary objective of this study is to assess the safety and tolerability of Tonapofylline administered to subjects with heart failure and renal insufficiency
High-dose Chemotherapy for Poor-prognosis Relapsed Germ-Cell Tumors
Jun 2009The goal of this clinical research study is to learn if bevacizumab, when given in combination with 2 cycles of high-dose chemotherapy, can help to control germ-cell tumors.
Vascular-targeted photodynamic therapy using WST11 in patients with localised prostate cancer
May 2009To determine the optimal treatment conditions to achieve prostate cancer tumor ablation and to assess the effects of WST11 mediated VTP treatment in patients with localized prostate cancer with both normal (<60cc) and high-volume prostates (≥60cc).
Non-invasive detection of prostate cancer using functional MRI in patients with histopathologically confirmed prostate cancer before prostatectomy
May 2009The main object of the trial is to assess the diagnostic value of functional MRI (T2+DCE MRI) for the detection of prostate cancer (on the basis of 16 prostate segments) and to show superiority in the accuracy to detect prostate cancer compared to conventional T2 MRI (SOR: histopathology)
Safety Trial of Single Versus Multiple Dose Thymoglobulin Induction in Kidney Transplantation (STAT)
May 2009In a non-blinded pilot study conducted at the University of Nebraska Medical Center, evidence was found that a single large dose of Thymoglobulin on the day of kidney transplantation produced better kidney function than the standard dosing plan, when the same amount is divided into smaller doses on 4 days. This new study repeats that dose comparison, but with double-blinding and at multiple transplantation centers.
Studying a Tumor Marker for Testicular Cancer, Skin Cancer, Small Intestine Cancer, and Pancreatic Cancer
May 2009This research study is evaluating a tumor marker for testicular cancer, skin cancer, small intestine cancer, and pancreatic cancer.
Myocardial Glucose Uptake (MGU) in Patients With Chronic Kidney Disease
Apr 2009This study examines patients with chronic kidney disease-related anemia and measures changes in the metabolism of the heart using FDG/PET scanning, before and 6 months after their health-care provider has initiated anemia management therapy with the FDA-approved drug darbepoetin alfa (Aranesp), which is approved for chronic kidney disease-related anemia.
Community Oncology Setting Disease Outcomes of Sorafenib (Nexavar) Use in Advanced Renal Cell Carcinoma
Apr 2009A retrospective medical record abstraction study of at least 200 advanced renal cell carcinoma patients treated in the following settings: Patients with advanced renal cell carcinoma treated with Sorafenib (Nexavar) as second-line therapy after Sunitinib (Sutent) or Bevacizumab (Avastin) for first-line therapy (about 100 patients) Patients with advanced renal cell carcinoma treated with Sorafenib (Nexavar) as first-line therapy followed by Sunitinib (Sutent) as second-line therapy (about 100 patients)
Effect of ACE-inhibitors on Aortic Stiffness in Elderly Patients With Chronic Kidney Disease
Apr 2009The goal of this proposal is to investigate the potential for ACE-inhibitors (ACE-I)(drugs primarily used to treat hypertension or congestive heart failure) to prevent or delay cardiovascular disease (CVD) in older adults with chronic kidney disease (CKD) by examining their impact on aortic stiffness in people with stage 3 CKD in a randomized, controlled study.
A prospective, randomized, open label blinded end point (probe), cross-over study to compare the effects of telmisartan and losartan on metabolic profile of renal transplant patients
Mar 2009To compare the short-term effects of telmisartan and losartan on insulin sensitivity in kidney transplant recipients with stable renal function and concomitant treatment with steroids and/or calcineurin inhibitors.
Evaluation of Non-Invasive Assay(s) for the Detection of Bladder Cancer
Mar 2009The purpose of this study is to determine if analysis of DNA and protein material found in urine will be useful in the detection of bladder cancer progression. This analysis may be helpful to determine if how a particular cancer will act regarding remission and recurrence.
Mycophénolate sodic in graded increased doses in the first 3 months of renal transplantation _ Pharmacokinetic descriptive Pilot study
Mar 2009Describe the pharmacokinetics of the MYFORTIC ® ( MPA) with graded increased doses first 3 months of the renal transplantation
Two-Arm Study of a DNA Vaccine Encoding Prostatic Acid Phosphatase (PAP) in Patients With Non-Metastatic Castrate-Resistant Prostate Cancer
Feb 2009The main purpose of this study is to find out whether the vaccine generates long-lived immune responses, and whether a better schedule of vaccination can be found by doing frequent laboratory testing for immune responses.
Genetic Susceptibility to Bladder Cancer
Feb 2009This clinical research study will identify biologic and lifestyle factors which increase a person's risk of developing specific cancer. We propose to conduct a case-control study examining interindividual differences in susceptibility to tobacco carcinogenesis as predictors of bladder cancer risk. We will measure susceptibility to tobacco carcinogenesis and this will include studies of the genetic modulation of carcinogen activation and detoxification and of chromosome sensitivity to tobacco mutagens.
Autoantibody Blood Test in Finding Metastasis in Patients With Localized or Metastatic Kidney Cancer
Dec 2008This clinical trial is studying an autoantibody blood test in finding metastasis in patients with localized or metastatic kidney cancer.
Antibody Response to Human Papillomavirus Recombinant Vaccine (Gardasil®) in Girls and Young Women With Chronic Kidney Disease
Dec 2008People with chronic kidney disease are known to have immune response abnormalities, including a diminished response to some vaccinations. Those with chronic kidney disease have a disproportionate burden of HPV 6-, 11-, 16- and/or 18-related genital tract disease. Due to immune response abnormalities, the CKD population may or may not respond to the recommended three-dose regimen of Gardasil®, a vaccine intended to protect against HPV 6-, 11-, 16-, and 18-related genital tract disease. The objective of this study is to measure the antibody response to Gardasil® in female patients 9-21 years of age with chronic kidney disease (CKD) (Stage 1-4), end-stage kidney disease (Stage 5 CKD), and status-post kidney transplant. Gardasil® vaccine will be administered according to the FDA-approved schedule. Blood samples to measure antibody levels to vaccine strains of human papillomavirus (HPV) will be obtained at months 0, 7 and 24.
Effects of the dose of erythropoiesis stimulating agents on cardiac-cerebrovascular outcomes and quality of life in hemodialysis patients. The DOSe of Erythropoietins (DOSE) trial.
Nov 2008To evaluate the benefits and harms of high versus low EPOS doses for major patient-level outcomes (mortality, cardiac and cerebrovascular events, safety),quality of life and costs in a population of prevalent outpatient hemodialysis patients.
A Phase III, Randomized, Active Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of MK-0826/Ertapenem and Meropenem in Patients with Complicated Urinary Tract Infections
Nov 20081) To compare the efficacy of ertapenem with respect to the overall microbiological response assessment profile in the treatment of patients with serious (requiring hospitalization and treatment with parenteral therapy) complicated UTIs, including acute pyelonephritis, with that of the meropenem control group at the 5 to 9 days posttherapy (EFU/TOC) follow-up visit. 2) To compare the efficacy of ertapenem with respect to the clinical response assessment profile in the treatment of patients with serious complicated UTIs, including acute pyelonephritis, with that of the meropenem control group at completion of parenteral therapy (DCIV). 3) To compare the efficacy of ertapenem with respect to the overall microbiological response assessment profile in the treatment of patients with serious complicated UTIs, including acute pyelonephritis, with that of the meropenem control group at DCIV. 4) To evaluate the safety profile of ertapenem at DCIV.
Temocillin use in Complicated Urinary Tract Infections due to ESBL producing and AmpC hyperproducing Enterobacteriaceae in United Kingdom
Oct 2008Demonstrate efficacy and safety of temocillin in urinary tract infections due to Extended Spectrum Beta-Lactamases producing or AmpC hyperproducing Enterobacteriaceae.
Androgen Deprivation Therapy +/- Bevacizumab for PSA Recurrence of Prostate Cancer After Definitive Local Therapy
Oct 2008The purpose of this research study is to assess the efficacy of antiangiogenic therapy (bevacizumab) and androgen deprivation versus androgen deprivation alone at the time of minimal systemic disease (based on rising PSA without metastases).
A Phase II single-arm trial to evaluate cisplatin and gemcitabine chemotherapy in combination with sunitinib for first-line treatment of patients with advanced transitional carcinoma of the urothelium.
Oct 2008The objective of this trial is to assess whether the addition of sunitinib to standard cisplatin / gemcitabine (CG) cancer chemotherapy improves outcome for participants with advanced cancer of the urinary system (urothelial cancer). The primary objective is to assess the activity, safety and feasibility of using the 3−drug combination (SCG) in patients with advanced transitional cell carcinoma of the urothelium. The primary outcome measure is progression−free survival (PFS) at 6 months from date of enrolment. This is the proportion of participants who are alive at 6 months without disease progression, according to RECIST (Response Evaluation Criteria In Solid Tumours).
A randomized, controlled, open-label, multi-centre, parallel-group study to assess all-cause mortality and cardiovascular morbidity in patients with chronic kidney disease on dialysis and those not on renal replacement therapy under treatment with MIRCERA® or reference ESAs.
Oct 2008To demonstrate non-inferiority of MIRCERA® versus reference ESAs in terms of a composite endpoint of all-cause mortality and non-fatal cardiovascular events (myocardial infarction (MI), stroke).
Phase III Randomized Chemoprevention Study Of Selenium On The Recurrence Of Non-Invasive Bladder Cancer
Sep 2008The primary objective of the study is to determine the effect of selenium, in addition to standard care, on the recurrence of bladder cancer.
Vitamin D3 Substitution in Vitamin D Deficient Kidney Transplant Recipients (VITA-D)
Sep 2008The purpose of the study is to evaluate the effects of Cholecalciferol (Vitamin D3) substitution on the posttransplant outcome (glomerular filtration rate as well as serum creatinine levels, number of acute rejection episodes, number of infections and C-reactive protein levels within the first year after transplantation) in vitamin D deficient kidney transplant recipients.
A study assessing in vivo hepatic and intestinal CYP3A4/5 and PGP activity in kidney transplant recipients and its relationship with genetic and non-genetic variables and the pharmacokinetics and metabolism of Tacrolimus.
Sep 2008To asses in vivo hepatic and intestinal CYP3A4 and 5 and PGP activity in renal allograft recipients.
VITA-D: Cholecalciferol substitution in vitamin D deficient kidney transplant recipients: A randomized, placebo-controlled study to evaluate the posttransplant outcome
Sep 2008Does vitamin D3 substitution in vitamin D deficient kidney transplant recipients influence the posttransplant outcome compared to placebo?
Quality of Life in Patients With Bladder Cancer
Aug 2008The purpose of this study is to learn about the quality of life of people living with bladder cancer. We are interested in learning about how the treatments for bladder cancer affect people. We plan to use the findings from this study to help doctors provide better care and information to patients with bladder cancer.
Selenium in Preventing Cancer Recurrence in Patients With Bladder Cancer
Aug 2008This randomized phase III trial is studying selenium to see how well it works compared with a placebo in preventing cancer recurrence in patients with bladder cancer.
A 24-month extension to a 12-month, open-label, randomised, multicenter, sequential cohort, dose finding study to evaluate the efficacy, safety and tolerability of oral AEB071 versus Neoral® in combination with Certican®, Simulect® and corticosteroids in de novo adult renal transplant recipients
Jul 2008To characterise the general and renal-specific glomerular filtration rate (GFR) (MDRD) safety profile, up to 36 months post transplantation, of renal transplant patients treated with AEB071 in combination with Certican® (CNI free) versus a standard CNI-based regimen.
A phase III study to compare SonoVue guided prostate biopsy with systematic biopsy in the detection of prostate malignant lesions in patients with suspected prostate cancer
Jul 2008Determination of the potentiality of SonoVue to guide prostate biopsy increasing the detection rate of malignant lesions of 6% points in absolute terms compared to the detection rate of the conventional systematic biopsy on patients candidates to a bioptic procedure. The study population comprises both candidates to a first bioptic exam and candidates to a second bioptic procedure having had a previous negative result independently from the present study.
Randomized prospective phase II study of temsirolimus with or without low-dose interferon alpha in metastatic non-clear renal cell carcinoma: GOIRC study 02/2008
Jul 2008The main objective of this trial is to assess Overall Response Rate (RECIST Criteria); Time to Progression (TTP); Safety; Overall Survival (OS).
An randomized, controlled, investigator-blinded, prospective, mono-centre study to evaluate the efficacy of fosfomycin versus meropenem in patients with complicated urinary tract infections
Jul 2008This study will primarily address the question of the efficacy of intravenous fosfomycin 4 g b.i.d. in the therapy of patients presenting with complicated urinary tract infection. These data will be compared to meropenem administered intravenously at a dose of 2 g b.i.d.
Cardiac Function and Cardiovascular Risk Profile in Testicular Cancer Patients
Jun 2008This study is being done because it would be helpful to study heart function and cardiovascular disease risk factors of men who have been diagnosed with testicular cancer, before and after they receive chemotherapy treatment compared to men who receive treatment with surgery alone.
Intensive Dietary Education to Lower Serum Phosphorus in Patients With Chronic Kidney Disease
Apr 2008The purpose of this study is to determine the effects of a more intensive, innovative dietary phosphorus educational intervention on reducing serum phosphorus levels, as well as improving dietary adherence, dietary satisfaction and phosphorus knowledge level in patients with chronic kidney disease.
CyberKnife Radiosurgery for Organ-Confined Prostate Cancer: Homogenous Dose Distribution
Mar 2008The purpose of this study is to determine the effects of CyberKnife radiosurgery in patients with early stage organ-confined prostate cancer.
A Phase 2, Single-Arm Study of Pralatrexate in Patients with Advanced or Metastatic Relapsed Transitional Cell Carcinoma of the Urinary Bladder
Mar 2008To determine the objective response rate (CR + PR) for pralatrexate with concurrent vitamin B12 and folic acid supplementation in the treatment of patients with advanced or metastatic relapsed TCC (Transitional Cell Carcinoma) of the urinary bladder.
A controlled randomized open-label multicentre study evaluatiing if early conversion to everolimus (Certican) from cyclosporine (Neoral) in de novo renal transplant receipients can improve long-term renal function and slow down the progression of chronic allograft nephropathy
Jan 2008To compare the efficacy between treatment regimens by assessing the difference in renal function evaluated by measured glomerular filtration rate (mGFR) 12 months after renal transplantation (TX)
Adolescent Type 1 Diabetes Cardio-Renal Intervention Trial
Jan 2008To determine whether intervention with Angiotensin Converting Enzyme Inhibitors (ACEI), Statins, or a combination of both, when compared with placebo, will reduce urinary albumin excretion, decline in renal function and the risk for diabetic nephropathy (DN) and cardiovascular disease (CVD)
Study of Polyphenon E in Men With High-grade Prostatic Intraepithelial Neoplasia
Jan 2008The clinical study is a Phase II, randomized, double-blinded, placebo-controlled trial in men 30-80 years of age with biopsy proven HGPIN or atypical small acinar proliferation (ASAP) and no evidence of prostate cancer, prostatitis or urinary tract infection. A total of 272 men will be randomized to the study, with the goal of completing 240 evaluable participants. Participants who consent to the study and meet initial eligibility criteria will be undergo a one-week run-in period during which they will be asked to self-administer the supplement daily as well as complete study logs and two-day diet recall forms. Participants must meet all inclusion criteria and remain compliant during the run-in period to be randomized to a treatment arm. Participant will complete a quality of life (QOL) survey and have blood collected for baseline tests. Participants will be equally randomized (n=136 per arm) to blinded treatment with either Polyphenon E 200 mg epigallocatechin gallate (EGCG) twice a day (bid) or matching placebo. The planned intervention period is 12 months; participants will return for monthly clinic visits during the intervention period. After 3 and 6 months of intervention, blood will be drawn for serum chemistry and hematology, and other and lower urinary tract symptom (LUTS) and QOL assessments will be performed. In addition, at the 6 month visit, two-day diet recall forms will be collected, blood and urine will be collected, and repeat digital rectal exam (DRE) and prostatic specific antigen (PSA) will be performed. If there is a palpable prostate nodule or confirmed PSA increase (>0.75 ng/ml) at 6 months, a repeat biopsy will be performed. At the end of intervention (maximum of 12 months), a repeat prostate biopsy will be performed for post-intervention endpoint measurements. The primary endpoint of the study is a comparison of the incidence of prostate cancer between participants in the treatment vs. placebo arm; in addition, the prevalence of HGPIN or ASAP in pre-treatment and post-treatment biopsies in participants treated with Polyphenon E vs. placebo will be compared. If participants develop prostate cancer during the course of the study, the extent and grade of cancer will be assessed and compared between treatment groups.
A prospective randomized study of antibiotic prophylaxis for renal transplantation: short term vs standard treatment
Jan 2008Superiority of single dose - same incidence of infectious complications
Coping in African American Prostate Cancer Survivors (CAAPS)
Dec 2007This study will test the effectiveness of an 8-week group intervention for African American men who have been treated for prostate cancer.
Efficacy and safety of Alefacept in combination with Tacrolimus, Mycophenolate Mofetil and Steroids in de-novo kidney transplantation – a multicenter, randomized, double-blind, placebo controlled, parallel group study
Dec 2007The primary objective of this study is to evaluate the efficacy and safety of alefacept in a kidney transplant population. Data suggests that 12 weeks of treatment with alefacept in combination with tacrolimus, mycophenolate mofetil (MMF) and steroids may be more effective than and as safe as a combination therapy of tacrolimus with MMF and steroids. Effectiveness will be measured as the occurrence of and time to biopsy proven acute rejection at six months assessed locally.
Anxiety in Black Men With Prostate Cancer: Validation of the Memorial Anxiety Scale for Prostate Cancer in an Sample of Black Men
Dec 2007This study is being done to see if a standard tool used to check anxiety in white men works well for Black men.
Phase II Study of Adenovirus/PSA Vaccine in Men With Recurrent Prostate Cancer After Local Therapy APP21
Dec 2007The purpose of this study is to determine whether vaccination with the Ad/PSA vaccine will induce an anti-PSA immunity that will result in the destruction of the remaining prostate cancer cells.
Genetic Susceptibility to Tumor Recurrence and Progression in Patients With Non-Muscle Invasive Bladder Cancer
Dec 2007The purpose of the study is to see if we will be more able to tell what the risk is for bladder cancer to reoccur or worsen when genetics and risk factors are examined along with the stage and grade of the tumor. Superficial bladder cancer is a cancer that does not grow into the muscle layer of the bladder wall. Even though it is a superficial cancer, this type of cancer tends to come back after being treated and is often more aggressive when it returns. We already know, that the "stage" or how deeply the tumor grows into the bladder wall and the "grade" or how fast the tumor grows affect whether the tumor will come back or get worse over time. Now we use information about the stage and grade of your tumor to decide how to treat the tumor and how often you should be checked after the treatment is over. However, this has not been very reliable, because each person has unique genetic characteristics and other factors that are likely to affect what happens to the tumor over time. For instance, we know the risk for developing a cancer may be affected by your surroundings and other factors such as what you eat, the type of habits you have such as smoking, and the type of job you have, but not everyone exposed to the same risk factors gets a cancer. We believe this is due to unique genetic characteristics in each person which may help their body fight cancer.
Safety Study & Effectiveness of Docetaxel With RAD001 and Bevacizumab in Men With Advanced Prostate Cancer
Dec 2007Establish a maximal tolerated or optimal biologic dose of RAD001 in combination with docetaxel/bevacizumab
Randomized Study of LAROTAXEL + Cisplatin (LC) vs. Gemcitabine + Cisplatin (GC) in the First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer.
Nov 2007To compare Overall Survival (OS) of patients administered Larotaxel in combination with cisplatin for the treatment of locally advanced/metastatic urothelial tract or bladder cancer
Hepatic and intestinal CYP3A4/5 activity in renal transplantation.
Oct 2007To asses in vivo hepatic and intestinal CYP3A4 and 5 activity in renal allograft recipients at different time-points and in different clinical settings after renal transplantation.
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of AST-120 for Prevention of Chronic Kidney Disease Progression in Patients with Moderate to Severe Chronic Kidney Disease
Sep 2007To demonstrate AST-120, added to standard-of-care therapy in moderate to severe CKD, reduces the risk of progression of CKD as assessed by the development of a component of a triple composite endpoint (initiation of dialysis, kidney transplant, or doubling of sCr), when compared with placebo; and to demonstrate the general safety and tolerability of long-term AST-120 therapy in CKD patients.
A randomized, double-blind, placebo-controlled, parallel-group study to determine whether, in patients with type 2 diabetes at high risk for cardiovascular and renal events, aliskiren, on top of conventional treatment, reduces cardiovascular and renal morbidity and mortality.
Sep 2007The primary objective of this study is to determine whether aliskiren, when added to conventional treatment, compared to placebo, delays the occurrence of cardiovascular and /or renal complications in patients with type 2 diabetes at high risk for cardiovascular and renal events.
A multi-center, randomized, controlled trial with programmed introduction of Sirolimus-based, Calcineurin inhibitor free immunosuppression in recipients of non-heart-beating donor kidney grafts.
Aug 2007To compare the safety and efficacy of a programmed introduction of a Sirolimus-based, Calcineurin inhibitor free, maintenance immunosuppressive regime, three months after renal transplantation in recipients of a non-heart-beating donor kidney graft on: graft function as determined by eGFR and biopsy proven acute rejection rates at twelve months post randomization to programmed Sirolimus introduction
A phase II/III, randomised, two-arm comparison of maintenance lapatinib versus placebo after firrst-line chemotherapy in patients with HER1 and/or HER2 over expressing locally advanced or metastatic bladder cancer.
Aug 2007The main objective of the study is to compare progression-free survival (PFS) in patients with HER1 and/or HER2 over expressing stage IV bladder cancer who have been randomised to maintenance therapy with lapatinib or placebo following first-line chemotherapy
Evaluation of Diagnostic Value of Molecular Markers in Renal Cancer (CMM)
Jun 2007The aim of this study is to evaluate the diagnostic performance of the association cytology-molecular markers in imaging-indeterminate renal tumors (small solid tumors and cystic tumors ≥ Bosniak III). About 156 patients will be included in five French clinical centers including Saint-Etienne, Marseille, Grenoble, Toulouse, and Nancy.
Pharmacokinetical-clinical study of intravescical gemcitabine in patients with marker lesion of superficial transitional cell carcinoma of the bladder
Jun 2007The aim of this study is to define the optimal values of the next parameters for the intravescical administration of gemcitabine 20000 mg: pH of the instilled solution: pH 2.7-3.2 (unbuffered solution) or pH 5.5 (buffered solution) dwell time: 1 hour or 2 houres concentration of gemcitabine (20 mg/ml or 40 mg/ml)
A Phase I/II, Ascending, Multi-Dose Study of BMS-663513, An Agonistic Anti-CD137 Monoclonal Antibody, Administered Every Three Weeks to Patients with Metastatic or Locally Advanced Solid Malignancies.
Jun 2007To assess the safety and tolerability of BMS-663513 in the range of 0.3 mg/kg to 15 mg/kg administered once every 3 weeks to patients with metastatic or locally advanced solid malignancies in the dose escalation portion of the study. To estimate the reversible Grade 3-4 toxicity rate in the expanded dose cohorts of melanoma, ovarian and renal carcinoma patients at each of the 3 selected doses (1, 3 and 10 mg/kg).
A randomized,open-label,multicenter, parallel-group study of belatacept-based corticosteroid-free regimens in renal transplant
May 2007To assess the rate of AR in different corticosteroid-free belatacept-based immunosuppressive regimens in de novo renal transplant subjects by 6 months post-transplant
Sunitinib Malate in Patients With Non-Clear Cell Renal Cell Cancer
Apr 2007To determine the clinical activity of SUTENT® (sunitinib malate) in non-clear cell renal cell cancer (RCC). Clinical activity will take into account response rate and progression free survival (PFS).
Vaccine Therapy With PROSTVAC/TRICOM and Flutamide Versus Flutamide Alone to Treat Prostate Cancer
Mar 2007To determine if treatment with a prostate cancer vaccine plus flutamide is more effective than flutamide alone in delaying disease progression in patients with prostate cancer.
An open study to investigate the effect of 4 instead of 2 daily dosing mycophenolate mofetil (MMF) in renal transplant patients on diarrhea
Mar 2007The main objective is to find out if dividing the daily oral dose prevents diarrhea without increasing risk of graft failure.
Study to Assess Darbepoetin Alfa Dosing for the Correction of Anemia in Pediatric Subjects With Chronic Kidney Disease
Feb 2007The primary objectives of this study are the following: 1. To test if the proportion of subjects achieving a hemoglobin value greater than or equal to 10.0 g/dL at any time point after the first dose during the study is greater than 0.8 when administered de novo darbepoetin alfa QW for treatment of anemia in pediatric subjects with chronic kidney disease receiving and not receiving dialysis, and 2. To test if the proportion of subjects achieving a hemoglobin value greater than or equal to 10.0 g/dL at any time point after the first dose during the study is greater than 0.8 when administered de novo darbepoetin alfa Q2W for treatment of anemia in pediatric subjects with chronic kidney disease receiving and not receiving dialysis.
A multicenter, single-arm, open, conversion study from a cyclosporine (CYA) based immunosuppressive regimen to a tacrolimus modfied release, FK506E (MR4), based immunosuppressive regimen in kidney transplant subjects
Jan 2007Primary objective is to assess the changes in kidney function in kidney transplant subjects converted from a CyA-based immunosuppressive regimen to a tacrolimus modified release, FK506E (MR4), based immunosuppressive regimen.
A Phase III Randomised Double-blind Study Comparing Sorafenib With Placebo In Patients With Resected Primary Renal Cell Carcinoma at High or Intermediate Risk of Relapse
Jan 2007The principal research question is whether sorafenib increases disease free survival (DFS) i.e reduces the risk of kidney cancer returning.
A multi-centre, open-label, phase II study of the safety, efficacy and pharmacokinetic (PK) profile of CAP-232 administered through continuous intravenous infusion in patients with metastatic kidney cancer
Nov 2006The primary objective of this study is to evaluate the efficacy of CAP-232 as a monotherapy (each 28-day cycle consists of 21 days continuous IV infusion of CAP-232 at 0.5 mg/kg/day followed by a 7-day rest period) in patients with metastatic kidney cancer.
The Effect of Treating Patients with Anaemia in Diabetic Nephropathy to different target haemoglobin levels with Epoetin Beta
Nov 2006To determine whether treating patients with Anaemia and Diabetic Nephropathy with EPOETIN BETA to different target haemoglobin ranges has an effect on rate of deterioration of renal function, need for dialysis and death.
Oral Celecoxib combined with BCG instillation therapy in treatment of carcinoma in situ (CIS), TaG3 and T1 disease of urinary bladder
Oct 2006The aim of this study is to assess the efficacy of Oral Celecoxib combined with BCG instillation therapy in treatment of carcinoma in situ (CIS), TaG3 and T1 disease of urinary bladder
Randomised Trial of Anti-CD20 in C4d+ Chronic Allograft Nephropathy
Oct 2006To determine whether anti-CD20 therapy can stabilise or improve renal function and/or proteinuria in patients with C4d+, chronic (humoral) rejection in whom standard therapeutic approaches have failed.
Intravenous Iron in Patients With Severe Chronic Heart Failure and Chronic Kidney Disease
Oct 2006The aim of the trial is to assess the efficiency of intravenous iron therapy in the management of mild to moderate anemia associated with CHF NYHA III class and concomitant moderate CKD.
Hyperthermia Treatment in Conjunction With Mitomycin C Versus BCG for Superficial Bladder Cancer
Oct 2006The study is a randomized controlled study, designed to test the efficacy and safety of a new treatment modality for the prevention of tumor recurrence in superficial bladder cancer.
A randomised phase III placebo-controlled trial evaluating the addition of celecoxib to standard treatment of transitional cell carcinoma of the bladder
Jul 2006The main objectives of the trial are to determine if the addition of the oral COX-2 inhibitor celecoxib to standard therapy is more effective in terms of disease recurrence at 3 years than standard therapy alone for the treatment of superficial TCC of the bladder at high risk of recurrence. To determine if the addition of the oral COX-2 inhibitor celecoxib to standard therapy is more effective in terms of disease recurrence at 3 years than standard therapy alone for the treatment of superficial TCC of the bladder at intermediate risk of recurrence.
A 12-week multicentre, randomised, double-blind, parallel group, Phase II pilot study to evaluate the efficacy and safety of cizolirtine citrate 200 mg bid (400 mg/d), cizolirtine citrate 300 mg bid (600 mg/d) and cizolirtine citrate 400 mg bid (800 mg/d) versus placebo in the treatment of patients with Stress Urinary Incontinence (SUI)
Apr 2006The primary objective is to evaluate the efficacy of cizolirtine citrate 200 mg twice daily, 300 mg twice daily, and 400 mg twice daily versus placebo in decreasing the frequency of incontinence episodes.
Mechanism of Action of High-Dose IL-2 (Aldesleukin) in Metastatic Melanoma and Kidney Cancer
Mar 2006To better understand how IL-2 causes tumors to shrink.
An Open-Label, Multi-Centre, Extension Study, evaluating the Long-Term Safety and Tolerability of Different Three-Month Degarelix Dosing Regimens, 240 mg (40 mg/mL), 240 mg (60 mg/mL), in Patients with Prostate Cancer.
Jan 2006To evaluate the safety and tolerability of different dosing regimens
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