@article{77ef4c37a5c84cb6b90775beb126cd79,
title = "Two long-term phase 3 studies of enarodustat (JTZ-951) in Japanese anemic patients with chronic kidney disease not on dialysis or on maintenance hemodialysis: SYMPHONY ND-Long and HD-Long studies",
abstract = "Enarodustat (JTZ-951) is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor developed for treating anemia in chronic kidney disease. Two open-label, uncontrolled phase 3 studies evaluated the 52-week safety and efficacy of enarodustat in Japanese anemic patients with chronic kidney disease not on dialysis (n = 132) [SYMPHONY ND-Long study] or on maintenance hemodialysis (n = 136) [SYMPHONY HD-Long study]. The most frequent adverse events were viral upper respiratory tract infection (25.8%) followed by chronic kidney disease (8.3%) in the SYMPHONY ND-Long study, and viral upper respiratory tract infection (49.3%) followed by contusion (16.9%) and diarrhea (16.9%) in the SYMPHONY HD-Long study. The incidence of any adverse events did not increase over time. Mean hemoglobin levels and 95% confidence intervals were maintained within the target range (10.0–12.0 g/dl) over 52 weeks in both studies. The long-term safety and efficacy of enarodustat were confirmed in Japanese anemic patients with chronic kidney disease.",
keywords = "anemia, chronic kidney disease, enarodustat, hypoxia-inducible factor prolyl hydroxylase inhibitor, long-term study",
author = "Tadao Akizawa and Masaomi Nangaku and Takuhiro Yamaguchi and Ryosuke Koretomo and Kazuo Maeda and Osamu Yamada and Hideki Hirakata",
note = "Funding Information: Tadao Akizawa reports personal fees from Japan Tobacco Inc., during the study, and personal fees from Astellas, Bayer Yakuhin Ltd., Kyowa Kirin Co. Ltd., Kissei Pharmaceutical Co. Ltd., Ono Pharmaceutical Co. Ltd., Fuso Pharmaceutical Industries Ltd., Torii Pharmaceutical Co. Ltd., GlaxoSmithKline, Nipro Corporation, Otsuka Pharmaceutical, Sanwa Chemical, Chugai Pharmaceutical Co. Ltd. and Mitsubishi Tanabe Pharma Corporation outside the submitted work. Masaomi Nangaku reports grants and personal fees from Japan Tobacco Inc., during the study, and personal fees from Kyowa Kirin Co. Ltd, Astellas, Astra Zeneca, GlaxoSmithKline, Mitsubishi Tanabe Pharma Corporation, Akebia Therapeutics Inc., Bayer Yakuhin Ltd., and Torii Pharmaceutical Co. Ltd. and grants from Kyowa Kirin Co. Ltd., Astellas, Mitsubishi Tanabe Pharma Corporation, Bayer Yakuhin Ltd., and Torii Pharmaceutical Co. Ltd. outside of the submitted work. Takuhiro Yamaguchi reports personal fees from Japan Tobacco Inc., during the study, and personal fees from Ono Pharmaceutical Co. Ltd., Kowa, Chugai Pharmaceutical Co. Ltd, TSUMURA&Co., CAC Croit Corporation, Kyowa Kirin Co. Ltd., Daiichi Sankyo, ASAHI INTECC, Asahi Kasei Corporation, Kaken Pharmaceutical, 3H Clinical Trial Co. Ltd., Welby, 3H Medi Solution, and Nipro Corporation, and grants from Ono Pharmaceutical Co. Ltd., CAC Croit Corporation, Kyowa Kirin Co. Ltd., Daiichi Sankyo, 3H Clinical Trial Co. Ltd., AC Medical, A2 Healthcare, Facet Biotech, Japan Media Corporation, Luminary Medical, Medidata Solutions Inc., Senju Pharmaceutical, Otsuka Pharmaceutical, Eisai, FMD K&L Japan, Intellim, Welby, 3H Medi Solution, Nipro Corporation, Hemp Kitchen, NOBORI, Puravida Technologies LLC., and Medrio Inc. outside the submitted work. Hideki Hirakata reports personal fees from Japan Tobacco Inc., during the study, and personal fees from Kyowa Kirin Co. Ltd., Chugai Pharmaceutical Co. Ltd., and Torii Pharmaceutical Co. Ltd. outside the submitted work. Ryosuke Koretomo, Kazuo Maeda, and Osamu Yamada are employees of Japan Tobacco Inc. and have stock or stock options in Japan Tobacco Inc. Funding Information: These studies were funded by Japan Tobacco Inc. and Torii Pharmaceutical Co. Ltd. We would like to thank all the physicians, nurses, and patients at the participating centers for their support. We acknowledge the editorial support of ASCA Corporation (http://www.asca-co.com/english_site/) for proofreading a draft of this manuscript. Publisher Copyright: {\textcopyright} 2021 The Authors. 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.",
year = "2022",
month = apr,
doi = "10.1111/1744-9987.13724",
language = "English",
volume = "26",
pages = "345--356",
journal = "Therapeutic Apheresis and Dialysis",
issn = "1744-9979",
publisher = "Wiley-Blackwell",
number = "2",
}
