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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...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley & Sons Australia, Ltd
2021
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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. |
format | Online Article Text |
id | pubmed-9290504 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | John Wiley & Sons Australia, Ltd |
record_format | MEDLINE/PubMed |
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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