Clinical Trials
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Transplantation
Effect of 3g Versus 2 g MMF in Combination With Tacrolimus on Progression of Renal Allograft Interstitial Fibrosis
May 2013Development of chronic changes (scarring) in transplanted kidney tissue is a major cause of long-term kidney function deterioration and ultimately graft loss. It results from both immunologic and non-immunologic mechanisms. Mycophenolate mofetil (MMF) is immunosuppressive drug used for prevention of rejection after kidney transplant, usually in combination with a calcineurin inhibitor (tacrolimus or cyclosporine), with or without corticosteroids. Besides immunosuppression, MMF may also have direct antifibrotic properties. Tacrolimus has potent immunosuppressive effects and is the cornerstone of contemporary posttransplant immunosuppressive therapy in kidney recipients. However, it is also nephrotoxic. The hypothesis of the present study is that in the setting of similar net immunosuppression, higher dose of MMF (3 g daily) will result in slower progression of kidney fibrosis during first year posttransplant as compared to MMF 2 g daily. To test this hypothesis, the present study will randomly assign low immunological risk kidney transplant recipients to either 2g or 3 g MMF daily, in combination with tacrolimus, with, or without maintenance steroids. All patients will have kidney biopsy at implantation and at 12 months after transplantation. Main outcome will be 1-year change in chronic kidney histology (interstitial fibrosis) assessed by protocol biopsy.
Adherence Enhancement for Renal Transplant Patients
May 2013Despite significant advances in the care of kidney transplant recipients, long term graft survival after renal transplantation remains suboptimal. Medication nonadherence and clinical inertia are key contributors to graft loss. The purpose of the proposed RCT feasibility study is to evaluate impact of a bundled wireless real time medication reminder system and blood pressure monitoring system in combination with a cognitive behavioral adherence skills enhancement program upon medication adherence, therapeutic drug concentration, and blood pressure, in nonadherent kidney transplant recipients with hypertension. We propose to recruit 60 kidney transplant recipients in phase 1 with 20 non-adherent continuing to phase 2 for a 5-month feasibility RCT.
Extracorporeal Photopheresis in Liver Transplantation. Phase II Clinical Trial in Safety and Efficacy in Patients With Gradual Decrease of Immunosuppression. (FEC-TH)
Apr 2013The purpose of this study is to evaluate the safety of extracorporeal photopheresis in patients with long-standing liver transplantation subjected to a progressive reduction of immunosuppression by complications arising from its use.
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.
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 to Assess Efficacy & Safety of Reparixin in Pancreatic Islet Transplantation (REP0211)
Mar 2013The chemokine CXCL8 plays a key role in the recruitment and activation of polymorphonuclear neutrophils in post-ischemia reperfusion injury after organ transplantion. Reparixin is the first low molecular weight blocker of CXCL8 biological activity in clinical development. Thus, the use of reparixin may emerge as a potential key component in the sequentially integrated approach to immunomodulation and control of non specific inflammatory events surrounding the early phases of pancreatic islet transplantation in type 1 diabetes (T1D) patients.
Open-label, Single Arm, Phase 2 Study to Evaluate the Safety and Efficacy of the Combination of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Coadministered with Ribavirin (RBV) in Adult Liver Transplant Recipients with Genotype 1 Hepatitis C Virus (HCV) Infection
Mar 2013The primary objectives of this study are to assess safety and efficacy (the percentage of subjects achieving a 12-week sustained virologic response, SVR12 (HCV ribonucleic acid [RNA] < lower limit of quantification [LLOQ] 12 weeks following treatment) of coformulated ABT-450/r and ABT-267 (ABT-450/r/ABT-267) and ABT-333 coadministered with RBV for 24 weeks in HCV genotype 1-infected adult liver transplant recipients.
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.
Assessment of Revascularization Versus Conservative Treatment in Heart Transplant Patients for a Clinical Event Reduction (ARCHER)
Feb 2013The aim of the study is to compare optimal medical therapy alone versus percutaneous coronary intervention on top of medical therapy in the setting of heart transplant recipient coronary artery disease in a randomized trial.The primary endpoint assessed at 1 year is the composite of death, myocardial infarction, need for transitory or permanent ventricular assist device implantation, myocardial revascularization, occurrence or worsening of heart failure, any graft dysfunction and/or a decrease of left ventricular ejection fraction of at least 25% compared to baseline. The hypothesis of the study is the superiority of the interventional management over medical therapy alone in preventing the occurrence of the primary endpoint of the study.
Immuno-humoral Rejection Markers in Pulmonary Transplant (RHUM-TP)
Feb 2013Open multicentric prospective study performed on pulmonary transplanted patients to detect the values of different diagnostic markers for immuno- humoral reaction and their roles in the humoral rejection for those patients.
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.
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.
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.
Assessment of Hearts Deemed Unsuitable for Transplant With the Aim of Expanding the Donor Heart Pool.
Jan 2013The main question to be asked in this study is what is the potential for human hearts that have been deemed unacceptable for transplant, to be explanted and re-animated in a controlled, external environment to be assessed? Furthermore would the reanimated hearts be able to undergo improvement in their function in this external environment. Ultimately this may lead to an increase the number of hearts available for transplantation.
Determinants of Immunosuppressive Dose Requirements in Children After Solid Organ Transplantation
Jan 2013The long-term success of solid organ transplantation is largely dependent on the efficacy of immunosuppressive medication. Unfortunately, for the most important agents the correct drug levels are difficult to attain, with potential severe consequences of drug under- or overexposure. In addition there is a large variation in dose requirements within and between different subjects. Clinical studies have demonstrated that a better control of drug exposure can improve outcome. A large set of patient characteristics appear important in determining dose requirements in adults, in particular genetic variation in genes involved in drug metabolism. In children relative dose requirements are increased compared to adults, but is not known why and the role of pharmacogenetic variation has not been described. Our study aims to describe relative dose requirements in children after solid organ transplantation with the help of clinical and laboratory data obtained during regular hospital visits (retrospective). In addition we will assess their genotype for genes involved in the metabolism of immunosuppressives.
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])
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.
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.
A Pharmacokinetic Analysis of Posaconazole in the Plasma and Alveolar Compartment of Lung Transplant Recipients
Sep 2012a) To estimate the time taken to achieve a steady level (steady state) of posaconazole in the blood in cystic fibrosis (CF) and non-CF transplant recipients. b) To examine the relationship between blood posaconazole levels and posaconazole levels in the lungs in cystic fibrosis (CF) and non-CF transplant recipients.
A prospective phase II study to assess immunophenotypic remission after three-drug in-duction followed by randomized stem cell mobilization, autologous stem cell transplantation and lenalidomide maintenance in patients with newly diagnosed multiple myeloma
Sep 2012The objectives of this study is to determinate the rate of immunophenotypic remission after induction treatment with Revlimid Velcade Dexamethasone (RVD) prior to high-dose melphalan and autologous stem cell transplantation (HDT-ASCT), after HDT-ASCT, and during lenalidomide maintenance in patients with multiple myeloma.
Immunogenicity of repeated dose 13-valent pneumococcal conjugate vaccine compared to the existing recommended protocol of pneumococcal polysaccharide vaccine in adult kidney and liver transplant patients
Aug 2012To show the non-inferiority of Prevenar 13 compared to pneumovax
BE-RELACs-Trial: Biomarkers Explaining RELevance of ACute Rejections
Aug 2012To explore a number of biomarkers from plasma, serum and renal tissue to describe the impact of different strategies for immunosuppression (Belatacept, Cyclosporine) on the immune-system that may explain differences in long-term outcome.
A phase 3, multicenter, randomized, double-blind, parallel assignment study to assess the efficacy and safety of reparixin in pancreatic islet transplantation.
Aug 2012The objective of this clinical trial is to assess whether reparixin leads to improved transplant outcome as measured by glycaemic control following intra-hepatic infusion of pancreatic islets in T1D patients. The safety of reparixin in the specific clinical setting will be also evaluated.
A UK multicentre phase II study of haploidentical stem cell transplantation in patients with haematological malignancies
Jul 2012To investigate whether it is possible to carry out haploidentical/HLA mismatched donor peripheral blood stem cell transplants using high dose cyclophosphamide safely and effectively
A UK multicentre phase II study of haploidentical stem cell transplantation in patients with haematological malignancies
Jul 2012To investigate whether it is possible to carry out haploidentical/HLA mismatched donor peripheral blood stem cell transplants using high dose cyclophosphamide safely and effectively
A UK multicentre phase II study of haploidentical stem cell transplantation in patients with haematological malignancies
Jul 2012To investigate whether it is possible to carry out haploidentical/HLA mismatched donor peripheral blood stem cell transplants using high dose cyclophosphamide safely and effectively
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.
Personal monitoring of liver transplant patients infected with Hepatitis C Virus. Pilot study to compare the evolution of Hepatitis C by receiving immunosuppression with tacrolimus in combination with Mycophenolate Mofetil or Everolimus.
Jun 2012Compare the evolution of hepatitis C recurrence as determined by progression of liver fibrosis (F ? 2, as ranked by ISHAK) a year post-liver transplantation in patients receiving low dose tacrolimus in combination with mycophenolate mofetil vs everolimus.
An open, prospective, single arm study investigating efficacy and safety of human hepatitis B immunoglobulin Zutectra in liver transplanted patients - the ZEUS Study
Jun 2012To investigate the efficacy of Zutectra in orthotopic liver transplanted patients
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.
A Single Center, Prospective, Observational, Open-label, Pharmacokinetic Study of Tacrolimus in Heart and Lung Transplantation Patients during the First Days after Transplantation
Apr 2012To show that the variability of whole blood total and unbound plasma tacrolimus concentrations during the first 6 days post transplantation is larger than the variation of tacrolimus concentrations in stable clinical situation.
An Open-Label Study to Explore the Clinical Efficacy of GS-7977 with Ribavirin Administered Pre-Transplant in Preventing Hepatitis C Virus (HCV) Recurrence Post-Transplant
Apr 2012The primary objective of this study is to determine if the administration of a combination of GS-7977 and ribavirin to HCV-infected subjects with hepatocellular carcinoma (HCC) meeting the MILAN criteria prior to undergoing liver transplantation for up to 24 weeks can prevent post-transplant reinfection
as determined by a sustained post-transplant virological response (HCV RNA
Response-Adapted Sequential Azacitidine And Chemotherapy in Patients > 60 Years Old With Newly Diagnosed AML Eligible for Chemotherapy and allogeneic hematopoietic cell transplantation: A Multicentre Phase I/II study of the East German Hematology and Oncology Study Group (OSHO)
Apr 2012The objective of the trial is to assess efficacy and safety of induction therapy with response-adapted sequential azacitidine and conventional AML induction chemotherapy in patients > 60 years with newly diagnosed AML (at the dose level resulting from the dose evaluation phase of the trial).
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.
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 Hepatitis C Virus (HCV) Entry Inhibitor in Liver Transplant Recipients With HCV Infection
Feb 2012This study will test the safety and tolerability of HCV Entry Inhibitor ITX 5061 in Liver Transplant Recipients with Hepatitis C infection. The investigators hypothesize that ITX 5061 oral monotherapy will be safe in adults during and after liver transplantation and that therapy will also inhibit HCV infection of newly transplanted livers in adults with prior HCV infection.
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.
Phase-II study evaluating midostaurin in induction, consolidation and maintenance therapy also after allogeneic blood stem cell transplantation in patients with newly diagnosed acute myeloid leukemia exhibiting a FLT3 internal tandem duplication AMLSG 16-10
Jan 2012To evaluate the impact of midostaurin given in combination with intensive induction, consolidation including allogeneic hematopoietic stem cell transplantation and single agent maintenance therapy on event-free survival (EFS) in adult patients with AML exhibiting a FLT3-ITD.
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.
A 12 month, multi-center, open-label, randomized, controlled study to evaluate efficacy/safety and evolution of renal function of everolimus in co-exposure with tacrolimus in de novo liver transplant recipients
Jan 2012To demonstrate that an immunosuppressive regimen based on everolimus (EVR) in co-exposure with tacrolimus (TAC) has superior efficacy compared to tacrolimus alone on estimated glomerular filtration rate (MDRD-4 formula) at Month 12 in de novo liver transplant recipients.
Caspofungin Acetate, Fluconazole, or Voriconazole in Preventing Fungal Infections in Patients Following Donor Stem Cell Transplant
Jan 2012This randomized phase II trial studies how well caspofungin acetate works compared to fluconazole or voriconazole in preventing fungal infections in patients following donor stem cell transplant
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.
The ONE Study: A Unified Approach to Evaluating Cellular Immunotherapy in Solid Organ Transplantation – Reference Group Trial
Dec 2011To confirm the rate of acute kidney graft rejection in the study population under standard immunosuppressive therapy in order to corroborate historical renal transplantation statistics and generate reference ranges for future clinical research within The ONE Study.
Yttrium-90-labeled Daclizumab With Chemotherapy and Stem Cell Transplant for Hodgkin's Lymphoma
Nov 2011The objective of this study is to see if yttrium-90 daclizumab, high-dose chemotherapy, and stem cell transplants can treat HL that has not responded to earlier treatments.
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?
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 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.
NK Cell Based Non-Myeloablative Transplantation in (AML) Acute Myeloid Leukemia
Jun 2011This is a phase II multi-institutional therapeutic study of NK-cell based nonmyeloablative haploidentical transplantation for the treatment of high-risk acute myeloid leukemia (AML). Enrollment will use a two-stage design. Stage 1 will enroll 15 patients unless an early stopping rule is met. If 9 or more of these first 15 patients achieve leukemia free neutrophil engraftment at day +28 accrual will move to stage 2. In stage 2, an additional 28 patients will be enrolled for a total of 43 patients. Patients will be followed for disease response for 2 years.
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.
GDC-0449 in Treating Patients With High-Risk First Remission or Relapsed Multiple Myeloma Who Received an Autologous Stem Cell
Apr 2011This phase I trial is studying how well GDC-0449 works in treating patients with high-risk first remission or relapsed multiple myeloma who received an autologous stem cell transplant.
A Multicentre, Open-label, Pharmacokinetic Study of Modigraf® (Tacrolimus granules) in de novo Paediatric Allograft Recipients.
Mar 2011The principal objective is to find out how much of Modigraf is absorbed and used in the body and how fast it leaves the body. This is called pharmacokinetics (PK). The results will then help to decide how much Modigraf in future should be given to children and young people following transplantation.
A 3-Armed Prospective Randomized Controlled, Open-Labeled Phase III Trial to Evaluate Late Introduction of Cyclosporine or Everolimus versus a 5-day Delay of Cyclosporine in Combination with MMF in Liver Transplant Recipients with MELD-Scores≥25
Feb 2011The primary objective of the trial is to investigate the influence of CNI-free-“bottom up” immunosuppression compared to CNI-containing “bottom-up” immunosuppression and 5-day Cyclosporine delay and their influence on renal function at 12 months measured by estimated GFR using the abbreviated MDRD formula
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 phase II study to investigate the efficacy of cyclophosphamide as sole graft-versus-host-prophylaxis after allogeneic stem cell transplantation (OCTET-CY)
Jan 2011To assess the efficacy of post-transplantation cyclophosphamide as single-agent GvHD prophylaxis after allogeneic hematopoietic stem cell transplantation in patients with multiple myeloma or lymphoma and to describe the influence of the modified immunosuppression concept on relapse rates, minimal residual disease, immune reconstitution and chimerism.
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.
Pharmacokinetics of anidulafungin (Ecalta ®) given intravenously as antifungal prophylaxis to recipients of an allogeneic haematopoietic stem cell transplant following myeloablative chemotherapy or patients receiving intensive chemotherapy for AML-MDS who are at high risk for developing invasive fungal disease
Aug 2010To determine the pharmacokinetics of anidulafungin given once in every 2 days (q48h) or once in every 3 days (q72h) to patients undergoing an allogeneic haematopoietic stem cell transplant following myeloablative chemotherapy or receiving intensive chemotherapy for AML-MDS
Chemotherapy, Stem Cell Transplantation and Donor and Patient Vaccination for Treatment of Multiple Myeloma
Aug 2010To induce cellular and humoral immunity in allogeneic stem cell donors and recipients against the unique idiotype expressed by the recipient's myeloma. To determine whether antigen-specific immunity, induced in the stem cell donor, can be passively transferred to the allogeneic SCT recipient in the setting of a non-myeloablative conditioning regimen.
Phase II Study of the Adjunctive Use of Lenalidomide in Patients Undergoing Reduced Intensity Conditioning Allogeneic Transplantation for Multiple Myeloma
Aug 2010To evaluate the effect of Lenalidomide given after reduced intensity conditioned stem cell transplant on progression-free survival at 2 years in myeloma
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
Adefovir Plus Vaccination in Transplant Patients Without Hepatitis B That Receive a Core Antibody Positive Liver
Jun 2010The primary purpose of this study is to evaluate the efficacy of adefovir (ADV) in preventing de novo Hepatitis B in patients who receive Hepatitis B core antibody (HBcAb) positive grafts but who are not Hepatitis B Surface antigen (HBsAg) positive prior to transplant (Hepatitis B naive patients). The second objective is to evaluate the efficacy of accelerated vaccination with Hepatitis B in inducing innate immunity, thereby obviating the need for life-long antiviral therapy
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.
Efficacy and Safety of Niuliva® for the Prevention of Hepatitis B Virus Recurrence in Newly Orthotopic Liver Transplant Recipients
May 2010The aim of this clinical trial is to evaluate the efficacy and safety of Niuliva (Hepatitis B virus immune globulin) in the prophylaxis of hepatitis B virus (HBV) reinfection in patients submitted to liver transplantation due to HBV-induced liver disease by reaching and maintaining certain hepatitis B antibody (HBsAg) levels considered as protective during the first six months post-transplantation.
A randomized, double-blind, placebo-controlled Phase 3 study of SGN-35 (brentuximab vedotin) and best supportive care (BSC) versus placebo and BSC in the treatment of patients at high risk of residual Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT)
Apr 2010The primary objective of this study is to compare the progression-free survival (PFS) of SGN-35 and best supportive care (BSC) versus placebo and BSC.
A Randomized Phase III Study Comparing Conventional Dose Treatment Using a Combination of Lenalidomide, Bortezomib and Dexamethasone (RVD) to High-Dose Treatment with Peripheral Stem Cell Transplant in the Initial Management of Myeloma in Patients up to 65 Years of Age (IFM/DFCI 2009)
Mar 2010To compare progression-free survival (PFS) between Arm A and Arm B
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?
The influence of CYP3A5 and ABCB1 genotype on the pharmacokinetics of Prograf and Advagraf
Mar 2010The objectives of this study are 1) To determine the influence of CYP3A5 and ABCB1 genotypes on Advagraf pharmacokinetics 2) To compare the influence of these genotypes on the comparison between Prograf and Advagraf pharmacokinetics
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.
Latent Tuberculosis Infection in Bone Marrow Transplant Recipients
Nov 2009The aim of this study is to estimate the usefulness of a T cell-based assay (i.e. Quantiferon-Gold In-Tube assay) for diagnosis of latent tuberculosis infection (LTBI) in bone marrow transplant recipients. For this purpose, the investigators enrolled bone marrow transplant recipients and observed the developement of tuberculosis within 1 to 2 years after the transplantation.
Study of RAD001 in Patients With Relapsed/Refractory Hodgkin Lymphoma That Has Progressed After High-dose Chemotherapy and Autologous Stem Cell Transplant and/or After Gemcitabine- or Vinorelbine- or Vinblastine-based Treatment.
Nov 2009This study will assess RAD001 in patients with refractory or relapsed Hodgkin Lymphoma that has progressed after high-dose chemotherapy and Autologous Stem cell transplant and/or after gemcitabine- or vinorelbine- or vinblastine-based treatment.
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.
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.
Phase II efficacy and safety study of Dasatinib in Patients with Chronic and Accelerated Phase Chronic Myeloid Leukaemia Relapsing after Allogeneic Blood or Bone Marrow Transplantation
Jun 2009To assess the efficacy of Dasatinib therapy in chronic and accelerated phase BCR-ABL (+) CML patients that undergo molecular, cytogenetic or haematological relapse following SCT.
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.
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.
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
CML-SCT -IBFM Study Allogeneic stem cell transplantation for children and Adolescents with CML: Conditioning regimen, donor selection, supportive care and diagnostic procedures.
Feb 2009To evaluate whether transplant related mortality following allogeneic stem cell transplantation from unrelated donors for CML can be reduced by using a reduced intensity conditioning regimen. To prospectively evaluate the overall survival, the event free survival and the current leukemia free survival in patients undergoing allogeneic stem cell transplantation for CML using a standardised post-transplant monitoring and early intervention
A Phase II Study of Oral Panobinostat in adult patients with Relapsed/Refractory classical Hodgkin’s Lymphoma after High-dose Chemotherapy with Autologous Stem Cell transplant.
Nov 2008To determine the objective response rate to therapy with oral panobinostat in patients with refractory/relapsed classical HL using modified response criteria for malignant lymphoma
Early salvage with high dose chemotherapy and stem cell transplantation in advanced stage Hodgkins lymphoma patients with positive positron emission tomography after two courses of ABVD (PET-2 positive) and comparison of radiotherapy versus no radiotherapy in PET-2 negative patients.
Sep 2008To evaluate if patients considered a failure of the initial treatment, for residual PET positivity after the first two courses of ABVD (PET-2 positive), can be salvaged with an early shift to high-dose chemotherapy supported by stem cell rescue.
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?
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.
Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia
Mar 2008This clinical trial is studying how well an autologous stem cell transplant works in treating patients with acute myeloid leukemia.
Phase ll Study of the Adjunctive Use of Azacitidine in Patients Undergoing Reduced Intensity Allogeneic Transplantation for Acute Myeloid Leukaemia
Feb 2008To assess the safety and tolerability of Azacitidine in patients following reduced intensity conditioned allogeneic transplantation for AML.
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)
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
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.
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 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
Primary fungal profilaxis with Liposomal Amphotericin B at the dose of 10 mg/kg a week in adult patient undergoing orthotopic liver transplantation and high risk for postoperative fungal infection: a prospective study
Jun 2007The main objective of the trial is to evaluate the safety of liposomal amphotericin B at the dose of 10 mg/Kg a week for 3-4 weeks
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
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.
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.
Allogenic stem cell transplantation in children and adolescents with acute lymphoblastic leukaemia
Jan 2007To evaluate whether HSCT from matched family or unrelated donors (MD) is equivalent to the HSCT from matched sibling donors (MSD). To evaluate the efficacy of HSCT from mismatched family or unrelated donors (MMD) as compared to HSCT from MSD/MD. To determine whether therapy has been carried out according to the main HSCT protocol recommendations. The standardisation of the treatment options during HSCT from different donor types aims at the achievement of an optimal comparison of survival after HSCT with survival after chemotherapy only. To prospectively evaluate and compare the incidence of acute and chronic GvHD after HSCT from MSD, from MD and from MMD.
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.
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