Safety of Daprodustat for the Treatment of Chronic Kidney Disease Anemia: Final Analysis of a Multicenter Postmarketing Surveillance Study in Japan

Introduction This final analysis of a multicenter, prospective postmarketing surveillance study evaluated the safety of daprodustat in patients with chronic kidney disease anemia in routine clinical practice in Japan. Methods Patients who initiated daprodustat between September 2020 and July 2022 were registered. The observation period was 52 weeks from treatment start or until discontinuation to assess overall safety, with an additional 52‐week follow‐up for cancer‐related events. Results Of 1634 patients in the safety analysis set, adverse drug reactions (ADRs) occurred in 5.6% (4.8% not undergoing dialysis; 6.9% undergoing peritoneal dialysis; 6.6% undergoing hemodialysis) and serious ADRs in 2.2%. ADRs related to thromboembolism, hypertension, cardiovascular events, cancer, and retinal hemorrhage were reported in less than 1%, with no progression of autosomal dominant polycystic kidney disease. During follow‐up, no increase in cancer‐related events was observed. Conclusions No new safety concerns were identified for daprodustat in the real‐world setting in Japan. Trial Registration: GSK study: 214119