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

• Published in: Therapeutic apheresis and dialysis Vol. 26; no. 2; pp. 345 - 356
• Main Authors: Akizawa, Tadao, Nangaku, Masaomi, Yamaguchi, Takuhiro, Koretomo, Ryosuke, Maeda, Kazuo, Yamada, Osamu, Hirakata, Hideki
• Format: Journal Article
• Language: English
• Published: Kyoto, Japan John Wiley & Sons Australia, Ltd 01.04.2022
• Subjects: anemia; Anemia - drug therapy; Anemia - etiology; chronic kidney disease; enarodustat; Hemoglobins - analysis; Humans; Hypoxia-Inducible Factor-Proline Dioxygenases; hypoxia‐inducible factor prolyl hydroxylase inhibitor; Japan; long‐term study; N-substituted Glycines; Original; Pyridines; Renal Dialysis - adverse effects; Renal Insufficiency, Chronic - complications; Renal Insufficiency, Chronic - therapy; Triazoles; Japan; long-term study; chronic kidney disease; enarodustat; anemia; hypoxia-inducible factor prolyl hydroxylase inhibitor
• ISSN: 1744-9979; 1744-9987
• DOI: 10.1111/1744-9987.13724

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.