BMJ Open 3:e001888 doi:10.1136/bmjopen-2012-001888
  • Pharmacology and therapeutics
    • Research

Anaemia management with C.E.R.A. in routine clinical practice: OCEANE (Cohorte Mircera patients non-dialysés), a national, multicenter, longitudinal, observational prospective study, in patients with chronic kidney disease not on dialysis

  1. Gabriel Choukroun5
  1. 1Department of Nephrology, Hôpital de Brabois, CHU, Vandœuvre-lès-Nancy, France
  2. 2Department of Nephrology, Dialysis and Renal Transplant, Hôpital Nord, Saint-Etienne, France
  3. 3Department of Biostatistics and Medical Computing, Hôpital Necker, Paris, France
  4. 4Roche, Boulogne-Billancourt, France
  5. 5Department of Nephrology, Internal Medicine and Medical Intensive Care, CHU, Amiens, France
  1. Correspondence to Dr Luc Frimat; l.frimat{at}
  • Received 10 August 2012
  • Revised 4 December 2012
  • Accepted 11 December 2012
  • Published 9 March 2013


Objective The aim of this study was to describe the management of anaemia with a continuous erythropoietin receptor activator (C.E.R.A., methoxy polyethylene glycol epoetin-β), in patients with chronic kidney disease (CKD) not on dialysis, naïve or non-naïve to treatment with erythropoiesis-stimulating agents (ESAs) at inclusion.

Design National, multicentre, longitudinal, observational prospective study.

Setting 133 nephrologists practicing in France selected patients during their routine follow-up visits. The study was non-interventional.

Participants They were adult CKD patients not on dialysis or kidney transplant patients, naïve or not to ESA treatment: 524 patients not on dialysis (48% ESA-naïve) and 92 kidney transplant patients (24% ESA-naïve) were included and followed up every 3 months during 1 year.

Outcome measures The two main endpoints were the percentage of patients who achieved target haemoglobin (Hb) levels as per European Medicines Agency guidelines (10–12 g/dl) around 6 months of treatment and modalities of treatment.

Results Approximately one in two patients had an Hb level within 10–12 g/dl at baseline, and around 6 and 12 months of treatment. Ninety per cent of ESA-naïve patients achieved at least +1 g/dl increase over baseline Hb levels or had Hb within 10–12 g/dl around 6 and 12 months. The Hb level remained at approximately 11.5 g/dl during the 12 months of follow-up. Around 6 months: almost all patients were receiving a once-monthly subcutaneous dose of C.E.R.A. (patients not on dialysis: 95±54 µg; kidney transplant patients: 121±70 µg); approximately half the patients did not require a change in C.E.R.A. dose. Adverse effects related to C.E.R.A. were observed in less than 5% of patients and led to modification or discontinuation of treatment in 2%.

Conclusions The efficacy and safety of C.E.R.A. in CKD patients not on dialysis, with or without kidney transplantation, were confirmed in routine clinical practice.

this is an open-access article distributed under the terms of the creative commons attribution non-commercial license, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. see: and

blog comments powered by Disqus