Clinical efficacies of C. E. R. A. (Continuous Erythropoietin Receptor Activator) administered intravenously to epoetin (EPO) naïve renal anemia patients on hemodialysis - Phase III study

Background: This study was designed to examine the clinical effects of C. E. R. A., a continuous erythropoietin receptor activator, administered intravenously (i. v.) at a dose level of 50 μg once every 2 weeks to EPO naïve renal anemia patients on hemodialysis. Methods: EPO naïve renal anemia patients were treated with C. E. R. A. i. v. at 50 μg once every 2 weeks during the correction period of anemia in order to attain the Hb levels of above 11 g/dL. The observation period established was 24 weeks, and the primary endpoint investigated was the percentage of patients who achieved the Hb levels of above 10 g/dL and the delta (Δ) Hb levels of 1 g/dL from baseline. Results: The Hb levels of renal anemia patients treated with C. E. R. A. were successfully corrected above 11 g/dL. The percentage of patients who attained Hb levels of above 10 g/ dL and the Δ Hb levels of above 1 g/dL from baseline was found to be 91.7%. It was shown from the present study, moreover, that the safety profiles of C. E. R. A. were similar to those of existing ESAs, erythropoiesis stimulating agents, and that the antibodies against C. E. R. A. were not detected in all the patients examined. Conclusions: This study has firstly disclosed that the administrations of C. E. R. A. i. v. at a dose level of 50 μg once every 2 weeks provided smooth as well as gradual increases of the Hb levels in patients with renal anemia on hemodialysis.