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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}chu-nancy.fr
  • Received 10 August 2012
  • Revised 4 December 2012
  • Accepted 11 December 2012
  • Published 9 March 2013

Abstract

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.

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