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C.E.R.A. Corrects Anemia in Patients with Chronic Kidney Disease not on Dialysis: Results of a Randomized Clinical Trial

Iain C. Macdougall^*, Rowan Walker, Robert Provenzano, Fernando de Alvaro, Harold R. Locay^||, Paul C. Nader^¶, Francesco Locatelli^**, Frank C. Dougherty, Ulrich Beyer; on behalf of the ARCTOS study investigators

^* Department of Renal Medicine, King's College Hospital, London, United Kingdom; Department of Nephrology, The Royal Melbourne Hospital, Parkville, Australia; Division of Nephrology, St. John Hospital and Medical Center, Detroit, Michigan; Nephrology Department, Hospital Universitario La Paz, Madrid, Spain; ^|| Discovery Medical Research Group, Ocala, Florida; ^¶ Capital Nephrology Associates of Texas Ltd., Austin, Texas; ^** Department of Nephrology and Dialysis, A. Manzoni Hospital, Lecco, Italy; and F. Hoffmann-La Roche Ltd., Basel, Switzerland

Correspondence: Dr. Iain C. Macdougall, Department of Renal Medicine, King's College Hospital, Bessemer Road, London, SE5 9RS, UK. Phone: +44-207-346-6234; Fax: +44-207-346-6472; E-mail: iain.macdougall{at}kch.nhs.uk

Background and objectives: This study examined the efficacy of C.E.R.A., a continuous erythropoietin receptor activator, for correcting anemia in patients who had chronic kidney disease (CKD) and were not on dialysis.

Design, setting, participants, & measurements: In this open-label, randomized, parallel-group, Phase III study, 324 adult patients with CKD not on dialysis nor receiving treatment with erythropoiesis-stimulating agents (ESAs) were randomly assigned (1:1) to receive subcutaneous C.E.R.A. once every 2 wk or darbepoetin alfa once weekly during an 18-wk correction period and a 10-wk evaluation period. Thereafter, patients receiving C.E.R.A. were randomly assigned to C.E.R.A. once every 2 wk or once monthly, and patients receiving darbepoetin alfa could receive darbepoetin alfa once weekly or once every 2 wk for a 24-wk extension period. Dosage was adjusted to achieve a hemoglobin (Hb) response and to maintain Hb ±1 g/dl of the response level and 11 to 13 g/dl. Primary end points were Hb response rate during correction and evaluation and change in Hb concentration between baseline and evaluation.

Results: Hb response rates were 97.5% for C.E.R.A. and 96.3% for darbepoetin alfa. Adjusted mean changes in Hb from baseline to evaluation were 2.15 g/dl (C.E.R.A.) and 2.00 g/dl (darbepoetin alfa). Analysis showed that C.E.R.A. once every 2 wk was as effective as darbepoetin alfa once weekly for correcting anemia. Hb levels remained stable in all groups during the extension period. C.E.R.A. and darbepoetin alfa were well tolerated.

Conclusions: Subcutaneous C.E.R.A. once every 2 wk corrects anemia in ESA–naïve patients who are not on dialysis.

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