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Clinical Trial
. 2022 Apr;26(2):368-377.
doi: 10.1111/1744-9987.13713. Epub 2021 Jul 31.

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

Tadao Akizawa  1 , Kiyoshi Nobori  2 , Yoshimi Matsuda  2 , Kentaro Taki  3 , Yasuhiro Hayashi  3 , Takanori Hayasaki  3 , Hiroyasu Yamamoto  4
Affiliations
Clinical Trial

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

Tadao Akizawa et al. Ther Apher Dial. 2022 Apr.

Abstract

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.

Keywords: anemia; erythropoiesis; renal dialysis; renal insufficiency.

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Conflict of interest statement

Tadao Akizawa received consulting and lecture fees from Bayer Yakuhin Ltd during the study. He also received consulting, lecture, or manuscript fees outside the submitted work from Astellas, GlaxoSmithKline, JT Pharmaceuticals, Kissei Pharmaceutical Co. Ltd, Kyowa Kirin, Nipro Corporation, Fuso Pharmaceutical Industries Ltd, Torii Pharmaceutical Co. Ltd, Sanwa Chemical Co. Ltd, Ono Pharmaceutical Co. Ltd, Otsuka Pharmaceutical Co. Ltd, Tanabe Mitsubishi Co. Ltd, and Chugai Pharmaceutical Co. Ltd. Hiroyasu Yamamoto received consulting and lecture fees from Bayer Yakuhin Ltd during the study. Kiyoshi Nobori, Yoshimi Matsuda, Kentaro Taki, Yasuhiro Hayashi, and Takanori Hayasaki are employees of Bayer Yakuhin Ltd.

Figures

FIGURE 1
FIGURE 1
Study design. EOF, end of follow‐up; EOT, end of treatment; ESA, erythropoiesis‐stimulating agent; W, week
FIGURE 2
FIGURE 2
Patient disposition. Completed study: completed both, treatment and follow‐up. ESA, erythropoiesis‐stimulating agent
FIGURE 3
FIGURE 3
Responder rate (full analysis set). Criterion 1: Mean Hb level within the target range of ≥11.0 and <13.0 g/dL during the evaluation period. Criterion 2: ≥50% of Hb levels in the target range during the evaluation period. Criterion 3: No rescue treatment received up to the end of the evaluation period
FIGURE 4
FIGURE 4
Mean (SD) Hb levels at study visits (full analysis set). Baseline Hb level was defined as the mean of the last two Hb levels during the screening period and the Hb level at Week 0. Dashed lines represent the boundaries of the target range. BL, baseline
FIGURE 5
FIGURE 5
Mean (SD) (A) serum iron concentration, (B) total iron binding capacity, (C) unsaturated iron binding capacity, (D) serum hepcidin 25 concentration, (E) serum ferritin concentration, and (F) serum transferrin saturation
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