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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,Paul C. Nader, Francesco Locatelli, Frank C. Dougherty,

On behalf of the ARCTOS study investigators Department of Renal Medicine, King’s College Hospital, London, United Kingdom ; The Royal Melbourne Hospital, Parkville, Australia ; Detroit, Michigan ; Research Group, Ocala, Florida ; Nephrology and Dialysis, A. Manzoni Hospital, Lecco, Italy; and Department of Nephrology, Division of Nephrology, St. John Hospital and Medical Center,Nephrology Department, Hospital Universitario La Paz, Madrid, Spain ; Discovery Medical. Capital Nephrology Associates of Texas Ltd., Austin, Texas ; Department of f. Hoffmann-La Roche Ltd., Basel, Switzerland

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 response level and 11 to 13 g/dl. Primary end points were Hb response rate during correction and evaluation and change inHb 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. 

Clin J Am Soc Nephrol 3: 337-347, 2008. doi: 10.2215/CJN.00480107

  

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