Molidustat for anemia correction in Japanese patients undergoing hemodialysis: a single‐arm, phase 3 study

Molidustat, an orally administered hypoxia‐inducible factor prolyl‐hydroxylase inhibitor, is under development for the treatment of anemia of CKD. This 24‐week, phase 3, single‐arm, multicenter study evaluated the efficacy and safety of molidustat in Japanese patients with renal anemia who were undergoing hemodialysis and who were not receiving an erythropoiesis‐stimulating agent. Twenty‐five patients received molidustat at a starting dose of 75 mg once daily, which was adjusted to maintain a Hb target of ≥10.0 to <12.0 g/dL. The mean rates of Hb increase from baseline and week 0 to the first dose change up to week 8 were −0.030 and 0.080 g/dL/week, respectively. By week 24, 89% of patients had a Hb level within target range. No adverse events of special interest were reported. Treatment with dose‐titrated molidustat for 24 weeks was well tolerated in Japanese patients undergoing hemodialysis, and no new safety signal was observed. Clinicaltrials.gov identifier: NCT03351166.