A Phase 3 Study of Enarodustat (JTZ-951) in Japanese Hemodialysis Patients for Treatment of Anemia in Chronic Kidney Disease: SYMPHONY HD Study

Autor: Tadao Akizawa, Masaomi Nangaku, Takuhiro Yamaguchi, Ryosuke Koretomo, Kazuo Maeda, Yuya Miyazawa, Hideki Hirakata
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Zdroj: Kidney Diseases, Pp 1-9 (2021)
Druh dokumentu: article
ISSN: 2296-9381
2296-9357
00051705
DOI: 10.1159/000517053
Popis: Introduction: Enarodustat (JTZ-951) is a new oral hypoxia-inducible factor-prolyl hydroxylase inhibitor for the treatment of anemia in chronic kidney disease (CKD). We conducted a phase 3 study to compare the efficacy and safety of enarodustat with darbepoetin alfa (DA) in Japanese anemic patients with CKD receiving maintenance hemodialysis. Methods: Subjects receiving maintenance hemodialysis were randomly assigned at a 1:1 ratio to receive oral enarodustat once daily or intravenous DA every week for 24 weeks with dose adjustment every 4 weeks to maintain hemoglobin (Hb) within a target range (≥10.0 to
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