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

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 eff...

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Autores principales: Akizawa, Tadao, Nobori, Kiyoshi, Matsuda, Yoshimi, Taki, Kentaro, Hayashi, Yasuhiro, Hayasaki, Takanori, Yamamoto, Hiroyasu
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley & Sons Australia, Ltd 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9290504/
https://www.ncbi.nlm.nih.gov/pubmed/34310049
http://dx.doi.org/10.1111/1744-9987.13713
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author Akizawa, Tadao
Nobori, Kiyoshi
Matsuda, Yoshimi
Taki, Kentaro
Hayashi, Yasuhiro
Hayasaki, Takanori
Yamamoto, Hiroyasu
author_facet Akizawa, Tadao
Nobori, Kiyoshi
Matsuda, Yoshimi
Taki, Kentaro
Hayashi, Yasuhiro
Hayasaki, Takanori
Yamamoto, Hiroyasu
author_sort Akizawa, Tadao
collection PubMed
description 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.
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spelling pubmed-92905042022-07-20 Molidustat for the treatment of anemia in Japanese patients undergoing peritoneal dialysis: a single‐arm, open‐label, phase 3 study Akizawa, Tadao Nobori, Kiyoshi Matsuda, Yoshimi Taki, Kentaro Hayashi, Yasuhiro Hayasaki, Takanori Yamamoto, Hiroyasu Ther Apher Dial Original Articles 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. John Wiley & Sons Australia, Ltd 2021-07-31 2022-04 /pmc/articles/PMC9290504/ /pubmed/34310049 http://dx.doi.org/10.1111/1744-9987.13713 Text en © 2021 Bayer Yakuhin Ltd. Therapeutic Apheresis and Dialysis published by John Wiley & Sons Australia, Ltd on behalf of International Society for Apheresis, Japanese Society for Apheresis, and Japanese Society for Dialysis Therapy. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle Original Articles
Akizawa, Tadao
Nobori, Kiyoshi
Matsuda, Yoshimi
Taki, Kentaro
Hayashi, Yasuhiro
Hayasaki, Takanori
Yamamoto, Hiroyasu
Molidustat for the treatment of anemia in Japanese patients undergoing peritoneal dialysis: a single‐arm, open‐label, phase 3 study
title Molidustat for the treatment of anemia in Japanese patients undergoing peritoneal dialysis: a single‐arm, open‐label, phase 3 study
title_full Molidustat for the treatment of anemia in Japanese patients undergoing peritoneal dialysis: a single‐arm, open‐label, phase 3 study
title_fullStr Molidustat for the treatment of anemia in Japanese patients undergoing peritoneal dialysis: a single‐arm, open‐label, phase 3 study
title_full_unstemmed Molidustat for the treatment of anemia in Japanese patients undergoing peritoneal dialysis: a single‐arm, open‐label, phase 3 study
title_short Molidustat for the treatment of anemia in Japanese patients undergoing peritoneal dialysis: a single‐arm, open‐label, phase 3 study
title_sort molidustat for the treatment of anemia in japanese patients undergoing peritoneal dialysis: a single‐arm, open‐label, phase 3 study
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9290504/
https://www.ncbi.nlm.nih.gov/pubmed/34310049
http://dx.doi.org/10.1111/1744-9987.13713
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