Efficacy of Intravenous Methoxy Polyethylene Glycol-Epoetin Beta Administered Every 2 Weeks Compared With Epoetin Administered 3 Times Weekly in Patients Treated by Hemodialysis or Peritoneal Dialysis: A Randomized Trial

Received 27 February 2007; accepted 30 August 2007. published online 31 October 2007.

Background

C.E.R.A. (methoxy polyethylene glycol-epoetin beta), a continuous erythropoietin receptor activator, was developed to provide stable control of hemoglobin (Hb) levels at extended administration intervals in patients with chronic kidney disease. We examined its efficacy for Hb level correction when administered once every 2 weeks in erythropoiesis-stimulating agent–naive dialysis patients.

Study Design

Open-label, multicenter, randomized, parallel-group, phase 3 study.

Setting & Participants

Dialysis patients (age ≥ 18 years).

Intervention

Patients (n = 181) were randomly assigned (3:1) to receive intravenous C.E.R.A. once every 2 weeks or epoetin 3 times weekly.

Outcomes & Measurements

The primary end point was Hb level response rate (increase in Hb level ≥ 1 g/dL [10 g/L] versus baseline and Hb level ≥ 11 g/dL [110 g/L] without blood transfusion during the 24-week correction period) in the intent-to-treat population.

Results

Hb response rates (intent-to-treat population) were 93.3% with C.E.R.A. and 91.3% with epoetin. Similar results were found in the per-protocol population. Peak mean Hb levels were 12.28 ± 1.13 (SD) g/dL (122.8 ± 11.3 g/L) with C.E.R.A. and 12.19 ± 1.24 g/dL (121.9 ± 12.4 g/L) with epoetin. Mean change in Hb levels from baseline to the end of the correction period were 2.70 ± 1.45 g/dL (27 ± 14.5 g/L) with C.E.R.A. and 2.56 ± 1.31 g/dL (25.6 ± 13.1 g/L) with epoetin. Both treatments were generally well tolerated.

Limitations

Open-label study design, 3:1 randomization, limited peritoneal dialysis population, descriptive statistics, and lack of formal prespecified comparison to epoetin.

Conclusions

Intravenous C.E.R.A. once every 2 weeks may be as safe and effective as 3-times-weekly epoetin for correcting anemia in dialysis patients. These results show the utility of intravenous C.E.R.A. administered once every 2 weeks in erythropoiesis-stimulating agent–naive dialysis patients.

Index Words: Chronic kidney disease, continuous erythropoietin receptor activator, C.E.R.A., epoetin, hemoglobin, renal anemia, anemia correction, methoxy polyethylene glycol-epoetin beta

1 Department of Nephrology and Transplantation Medicine, Medical University, Wroclaw, Poland

2 Servicio de Nefrologia, Hospital Marques de Valdecilla, Santander, Spain

3 Department of Nephrology, University Hospital, Alexandroupolis, Greece

4 Nephrology and Hypertension, Henry Ford Hospital, Detroit, MI

5 Collegium Medicum, Jagiellonian University Department of Nephrology, Cracow, Poland

6 Department of Nephrology, Chris Hani Baragwanath Hospital, Dumisami Mzamane African Institute of Kidney Diseases, Johannesburg, South Africa

7 Department of Nephrology, Transplantology and Internal Medicine, Pomeranian Medical University, Szczecin, Poland

8 F. Hoffmann-La Roche Ltd, Basel, Switzerland.

Address correspondence to Marian Klinger, MD, Department of Nephrology and Transplantation Medicine, Medical University, 57/59 Traugutta, 50-417 Wroclaw, Poland.

Trial registration: www.clinicaltrials.gov; study number: NCT00077597.

Originally published online as doi:10.1053/j.ajkd.2007.08.013 on October 30, 2007.

PII: S0272-6386(07)01197-3

doi:10.1053/j.ajkd.2007.08.013

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