C.E.R.A. corrects anemia in patients with chronic kidney disease not on dialysis: results of a randomized clinical trial.

Abstract

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.

• Authors: Iain C Macdougall, Rowan Walker, Robert Provenzano, Fernando de Alvaro, Harold R Locay, Paul C Nader, Francesco Locatelli, Frank C Dougherty, Ulrich Beyer, ARCTOS Study Investigators
• Journal: Clinical journal of the American Society of Nephrology : CJASN (Clin J Am Soc Nephrol) Vol. 3 Issue 2 Pg. 337-47 (Mar 2008) ISSN: 1555-905X [Electronic] United States
• PMID: 18287255 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Hematinics
• Recombinant Proteins
• continuous erythropoietin receptor activator
• Erythropoietin
• Darbepoetin alfa
• Polyethylene Glycols

Topics

• Aged
• Anemia (drug therapy, etiology)
• Chronic Disease
• Darbepoetin alfa
• Erythropoietin (analogs & derivatives, therapeutic use)
• Female
• Hematinics (therapeutic use)
• Humans
• Kidney Diseases (complications)
• Male
• Middle Aged
• Polyethylene Glycols (therapeutic use)
• Recombinant Proteins