Two long‐term phase 3 studies of enarodustat (<scp>JTZ</scp>‐951) in Japanese anemic patients with chronic kidney disease not on dialysis or on maintenance hemodialysis: <scp>SYMPHONY ND‐Long</scp> and <scp>HD‐Long</scp> studies
Tadao Akizawa, Masaomi Nangaku, Takuhiro Yamaguchi, Ryosuke Koretomo, Kazuo Maeda, Osamu Yamada, Hideki Hirakata
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.