A phase 3, open‐label, single‐arm study of vadadustat for anemia in chronic kidney disease for Japanese patients on hemodialysis not receiving erythropoiesis‐stimulating agents

Vadadustat is an oral hypoxia‐inducible factor prolyl hydroxylase inhibitor approved in Japan for the treatment of anemia in patients with chronic kidney disease (CKD). This phase 3, open‐label, single‐arm study evaluated the efficacy and safety of vadadustat in 24 Japanese patients with CKD‐associated anemia on hemodialysis who were not receiving erythropoiesis‐stimulating agents (ESAs). Patients received vadadustat for 24 weeks; the starting dose was 300 mg/day and doses were adjusted to achieve the target hemoglobin (Hb) range of 10.0–12.0 g/dL. The least squares mean of average Hb at Weeks 20 and 24 (95% confidence interval) was 10.75 g/dL (10.35, 11.14). The most common adverse event was shunt stenosis (25.0%). Adverse drug reactions (diarrhea and vomiting) occurred in two patients (8.3%) and the severity was mild. Vadadustat increased and maintained Hb levels within the target range and was generally well‐tolerated in Japanese patients with anemia on hemodialysis not receiving ESAs.