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. Issue 2 (2nd September 2021)

• Record Type: Journal Article
• Authors: Akizawa, Tadao; Nangaku, Masaomi; Yamaguchi, Takuhiro; Koretomo, Ryosuke; Maeda, Kazuo; Yamada, Osamu; Hirakata, Hideki
• Is Part Of: Therapeutic apheresis and dialysis. Volume 26:Issue 2(2022)
• Page Start: 345
• Page End: 356
• Publication Date: 2021-09-02
• Subjects: anemia -- chronic kidney disease -- enarodustat -- hypoxia‐inducible factor prolyl hydroxylase inhibitor -- long‐term study; Hemapheresis -- Periodicals; Dialysis -- Periodicals; Blood Component Removal -- Periodicals; Renal Dialysis -- Periodicals; Hémaphérèse -- Périodiques; Dialyse -- Périodiques; Sang -- Collecte et conservation -- Périodiques; 616
• DOI: 10.1111/1744-9987.13724
• Languages: English
• ISSNs: 1744-9979

Abstract

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.