Long-term safety and effectiveness of a continuous erythropoietin receptor activator (CERA) in patients with renal anemia: a prospective, observational, multicenter study

Abstract Background This observational study investigated the safety and effectiveness of continuous erythropoietin receptor activator in patients with renal anemia in Japan. Methods Patients were enrolled between August 2011 and November 2015 and followed for up to 1 year. Outcomes were analyzed according to disease stage (not receiving dialysis, on hemodialysis, on peritoneal dialysis). Results Three thousand six hundred eighty-four patients were enrolled (1678 not receiving dialysis, 1605 on hemodialysis, 392 on peritoneal dialysis, and 9 other). Study treatment was well tolerated with no new safety concerns; adverse drug reactions were reported in 3.06%, 4.19%, and 4.46% of patients. Study treatment improved or maintained hemoglobin levels in 54.05–77.27% of patients, including erythropoiesis stimulating agent-naïve responders (hemoglobin ≥10.0 g/dL and hemoglobin increase ≥ 1.0 g/dL until week 24) and erythropoiesis-stimulating agent-switched responders (hemoglobin 10.0–12.0 g/dL at week 48). Conclusions This study shows the safety and effectiveness of long-term continuous erythropoietin receptor activator for renal anemia.