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Once-Monthly Subcutaneous C.E.R.A. Maintains Stable Hemoglobin Control in Patients with Chronic Kidney Disease on Dialysis and Converted Directly from Epoetin One to Three Times Weekly

Wladyslaw Sulowicz^*, Francesco Locatelli, Jean-Philippe Ryckelynck, Jozsef Balla, Botond Csiky^||, Kevin Harris^¶, Patricia Ehrhard^**, Ulrich Beyer^**; on behalf of the PROTOS Study Investigators

^* Clinic of Nephrology Collegium Medicum, Jagiellonian University, Cracow, Poland; Department of Nephrology and Dialysis, "A Manzoni" Hospital, Lecco, Italy; Service de Néphrologie, CHU Clemenceau Centre, Caen, France; Department of Nephrology, University of Debrecen, Debrecen, and ^|| Fresenius Dialysis Center, University of Pecs, Pecs, Hungary; ^¶ Renal Services and Urology, Leicester General Hospital, Leicester, United Kingdom; and ^** Pharma Development, F. Hoffmann-La Roche Ltd., Basel, Switzerland

Address correspondence to: Prof. Wladyslaw Sulowicz, Collegium Medicum, Jagiellonian University Department of Nephrology, 15c Kopernika, 31-501, Cracow, Poland. Phone: +48-12-4247892; Fax: +48-12-4247149; E-mail: wladsul{at}mp.pl

Background: C.E.R.A., a continuous erythropoietin receptor activator, is in development to provide anemia correction and stable maintenance of hemoglobin (Hb) levels at extended administration intervals in patients with chronic kidney disease (CKD). This study examined its efficacy and safety when administered up to once monthly in patients who have CKD and are on dialysis and randomly convert directly from epoetin or ß one to three times weekly.

Design, setting, participants, and measurements: In this three-arm, comparator-controlled, open-label, randomized, parallel-group, Phase III study, 572 dialysis patients (18 yr) who were receiving stable subcutaneous epoetin one to three times weekly were randomly assigned (1:1:1) to continue epoetin or to receive subcutaneous C.E.R.A. once monthly or twice monthly for 52 wk. Dosage was adjusted to maintain Hb ±1.0 g/dl of baseline level. Primary end point was mean change in Hb level between baseline and the evaluation period (weeks 29 to 36).

Results: Mean Hb levels during the evaluation period were similar between groups (once-monthly C.E.R.A. 11.5 g/dl; twice-monthly C.E.R.A. 11.7 g/dl; epoetin 11.5 g/dl). The difference between C.E.R.A. and epoetin in mean change (97.5% confidence interval) in Hb concentration between baseline and evaluation was –0.022 g/dl (–0.262 to 0.217) for once monthly and 0.141 g/dl (–0.098 to 0.380) for twice monthly. Analysis demonstrated that C.E.R.A. was as effective as epoetin in maintaining Hb and was well tolerated.

Conclusions: Subcutaneous C.E.R.A. once or twice monthly successfully maintained tight and stable Hb levels in patients who were on dialysis and randomly converted directly from epoetin one to three times weekly.

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