Renal Anaemia Knowledge Centre

Mircera

MIRACEL study

First study in real-life setting confirms that once-monthly Mircera keeps haemoglobin levels within a tight range

The MIRACEL study is a multi-centre single arm study involving 422 patients from 90 dialysis centres across Germany treated with once-monthly Mircera. It is the first study using real-life data to look at the impact of Hb stability following directly switching dialysis patients from shorter-acting ESAs to once-monthly Mircera.

• The data presented were from the first 140 patients who had been previously treated with either epoetin alfa, beta or delta or darbepoetin alfa, administered three times a week (TIW) or once every two weeks (Q2W) either intravenously or subcutaneously and who were switched to once-monthly Mircera (QM) administered intravenously via pre-filled syringes.
• During the study evaluation phase (month 7, 8 and 9) the majority of patients (84%) had stable Hb levels (≤± 1 g/dL deviation from the individual mean).
• The median Mircera dose (125 µg QM) was the same at the start of the titration period and at the end of the evaluation period.
• Mircera was generally well tolerated, with a safety profile similar to that reported in all the Mircera Phase III studies. All the patients had some underlying illnesses, with 30% having diabetes.

Managing CKD is very time consuming, with physicians handling many other conditions in addition to anaemia, including high blood pressure, high cholesterol, cardiovascular disease and diabetes. A simplified approach to anaemia care could offer potential time saving benefits for healthcare staff and more convenience for patients.¹ Modelling data presented at the ERA-EDTA conference in Barcelona last year showed that it may be possible to cut nearly in half the annual time spent on anaemia management in a dialysis centre by using a once-monthly anaemia agent.²

Results demonstrate effective and simplified approach to anaemia management in chronic kidney disease patients on dialysis

The interim study results from 90 renal centres in Germany confirm for the first time that in a real-life setting Mircera^® maintains haemoglobin (Hb) levels within a narrow range when chronic kidney disease (CKD) patients receiving dialysis are switched to once-monthly Mircera from commonly used and frequently dosed erythropoiesis-stimulating agents (ESAs).³

The data, presented at the 41st Annual Meeting of the American Society of Nephrology (ASN) in Philadelphia, highlights Mircera's ability to keep Hb stable with simple once-monthly dosing. Keeping Hb in a narrow target range has become a hot issue for health authorities in the last year with international guidelines recommending it be kept between 11-12 g/dL. It is recognized that CKD patients are at a higher risk of death or hospitalization when their Hb fluctuates outside the recommended range.⁴ Keeping Hb within this narrow range however is a challenge with many patients experiencing Hb fluctuations; a previous study has shown that over a six month period only 6.5% of patients (on dialysis) had Hb which stayed in a target range of 11-12.5g/dL.^5,6

Dr Danilo Fliser (see video) of the Saarland University Medical Centre, Homburg, Germany and investigator for the MIRACEL study group who presented the data said "Across the many centres involved in the Miracel study physicians were administering four different ESAs with different dosing schedules and it is gratifying to see that when we simply switch to Mircera given once-a-month, we can effectively and safely manage anaemia. I believe this may offer physicians and nurses the opportunity to save time that can be redirected to optimizing patient care."

Learn more about this study (external website)

Learn more about Mircera^®

References:
1) Macdougall I, et al. C.E.R.A. Corrects Anemia in Patients with Chronic Kidney Disease not on Dialysis: Results of a Randomized Clinical Trial. CJASN, 2008; 3 (2) 337-347
2) Ulrich Saueressig, et al. Staff time and costs for anaemia management with erythropoietic stimulating agents in patients on haemodialysis. Abstract SaP341 44th ERA-EDTA Barcelona 2007
3) Fliser et al ASN 2008 abstract 553648. Once Monthly C.E.R.A. Provides Stable Hb Levels in CKD Patients On Dialysis Following Direct Switch From Short Acting ESAs.
4) Gilbertson D. T. et al. Hemoglobin Level Variability: Associations with Mortality. Clin J Am Soc Nephrol 3: 133-138, 2008
5) Fishbane S. and Berns J. S. Kidney International. 2005; 68/3:1337.
6) Ebben J. P, et al. J. Clin J Am Soc Nephrol. 2006; 1: 1205 - 1210.

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