Background: C. E. R. A., a continuous erythropoietin receptor activator, is currently under clinical development for the treatment of anemia at extended administration intervals. In the present study, we evaluated the therapeutic and safety profiles of C. E. R. A. after either SC or IV administration at a dosing interval of once every 4 weeks (Q4W) to renal anemia patients on peritoneal dialysis previously treated with rHuEPO. Methods: Renal anemia patients (n = 63) on peritoneal dialysis were assigned to one of the two treatment groups depending upon the previous rHuEPO doses administered. Patients who had received<4500 IU/wk rHuEPO were assigned to the 100 μg C. E. R. A. group, and those who had received ≧4500 IU/wk were assigned to receive 150 μg C. E. R. A. group. C. E. R. A. was administered Q4W via either SC (n = 35) or IV (n = 28) routes. After the 8-week switching period, the doses of C. E. R. A. Q4W were administered with dose adjustment rang-ing from 25 to 400 μg to maintain haemoglobin (Hb) levels of 10-12 g/dL during the 40-week maintenance period. Primary endpoint was the percentage of patients whose mean Hb maintained within the target Hb levels during 18-24 weeks. Results: C. E. R. A. Q4W administered successfully maintained the target Hb levels 61.9% during 18-24 weeks. A total of 88.9% of the pts successfully maintained these levels at 48 weeks. Furthermore, no significant differences in the maintenance rate were found between SC and IV routes of administration. Adverse event profiles were found to be similar between the two administration routes, and no antibodies against C. E. R. A. were detected in any patients examined. Conclusions: C. E. R. A. Q4W switching after a previous rHuEPO was adequate to maintain the target Hb levels, regardless of administration route (both SC and IV), therefore, is an effective treatment for the maintenance of Hb levels in peritoneal dialysis pts.
|Japanese Pharmacology and Therapeutics
|Published - 10-05-2011
All Science Journal Classification (ASJC) codes
- Pharmacology (medical)