Background: C. E. R. A. (Continuous Erythropoietin Receptor Activator) is an innovative erythropoiesis stimulating agent (ESA) with unique activity against erythropoietin receptor, and shows a significantly prolonged half-life after the administration. In the present study we evaluated the efficacy and safety profiles of subcutaneous (SC) or intravenous (IV) C. E. R. A. dosing once every 4 weeks (Q4W) in Japanese patients chronic kidney disease (CKD) not on dialysis previously treated with recombinant human erythropoietin (rHuEPO). Methods: CKD patients (n = 101) not on dialysis were assigned to 100 μg (n = 78) or 150 μg (n = 23) of C. E. R. A. by depending on previous rHuEPO doses of under 4500 IU/wk or over 4500 IU/wk, respectively. C. E. R. A. was administered Q4W via either SC (n = 70) or IV (n = 31) routes based on doctor's decision. After 8 weeks in switching period, the doses of C. E. R. A. Q4W were adjusted from 25 to 400 μg to maintain Hb levels of 11-13 g/dL (10-12 g/dL, in the patients with any histories or complications of cardiovascular diseases) as a maintenance period for the following 40 weeks. Primary endpoint was the percentage of patients whose mean Hb levels were within the 11-13 g/dL during 18-24 weeks. Results: The percentages of patients whose mean Hb levels maintain within each target Hb of 11-13 g/dL and 10-12 g/dL during 18-24 weeks were 79.2% and 100%, respectively. No significant differences in the maintenance rate were found between SC and IV route for 48 weeks. The mean (SD) slope of regression line of Hb levels were 0.116 (0.148) g/dL/week after switching from rHuEPO to C. E. R. A. administration. This parameter was also similar between both routes. Adverse event profiles were similar to those reported in rHuEPO and no antibodies against C. E. R. A. were detected in any patients examined. Conclusions: C. E. R. A. could safely switch from rHuEPO by dosing Q4W, successfully maintain target Hb levels of 11-13 g/dL by dose adjustment and is generally well tolerated in Japanese patients with CKD not on dialysis.
|ジャーナル||Japanese Pharmacology and Therapeutics|
|出版ステータス||Published - 10-05-2011|
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