Molidustat for the treatment of anemia in Japanese patients undergoing peritoneal dialysis: a single‐arm, open‐label, phase 3 study

• Published in: Therapeutic apheresis and dialysis Vol. 26; no. 2; pp. 368 - 377
• Main Authors: Akizawa, Tadao, Nobori, Kiyoshi, Matsuda, Yoshimi, Taki, Kentaro, Hayashi, Yasuhiro, Hayasaki, Takanori, Yamamoto, Hiroyasu
• Format: Journal Article
• Language: English
• Published: Kyoto, Japan John Wiley & Sons Australia, Ltd 01.04.2022
• Subjects: anemia; Anemia - drug therapy; Anemia - etiology; erythropoiesis; Erythropoietin - therapeutic use; Hematinics; Hemoglobins - analysis; Humans; Japan; Original; Peritoneal Dialysis - adverse effects; Pyrazoles; renal dialysis; Renal Dialysis - adverse effects; renal insufficiency; Renal Insufficiency, Chronic - therapy; Treatment Outcome; Triazoles; Japan; erythropoiesis; renal insufficiency; anemia; renal dialysis
• ISSN: 1744-9979; 1744-9987
• DOI: 10.1111/1744-9987.13713

This 36‐week, open‐label, single‐arm, phase 3 study investigated the safety and efficacy of molidustat in Japanese patients with renal anemia undergoing peritoneal dialysis. Molidustat was titrated every 4 weeks to maintain Hb levels within the target range (≥11.0 and <13.0 g/dL). The primary efficacy outcome was the responder rate, defined as the proportion of patients who met all of the following criteria: (1) mean Hb levels in the target range during the evaluation period (Weeks 30–36); (2) ≥50% of Hb values within the target range during the evaluation period; and (3) no rescue treatment before the end of the evaluation period. Overall, 51 patients received molidustat. The responder rate (95% CI) during the evaluation period was 54.9% (40.3, 68.9). Overall, 98.0% of patients experienced at least 1 adverse event during the study. No deaths were reported. Molidustat maintained Hb levels in the prespecified range in more than half of the patients and was well tolerated.