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A placebo-controlled, randomized trial of enarodustat in patients with chronic kidney disease followed by long-term trial

American Journal of Nephrology Feb 02, 2019

Akizawa T, et al. - In anemic patients with chronic kidney disease (CKD) not on dialysis, researchers assessed the efficacy, safety, and maintenance dose of enarodustat (JTZ-951), an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that mimics adaptive responses to hypoxic conditions. The correction group comprised erythropoiesis-stimulating agent (ESA) naïve patients. Patients on a stable dose of ESA were included in the conversion group. Both the groups were randomized to receive 2, 4, or 6 mg of enarodustat or placebo once daily for 6 weeks in a double-blind manner (Period 1) followed by 24 weeks of open enarodustat treatment to maintain their hemoglobin (Hb) levels within a target range of 10.0–12.0 g/dL in reference to a dose adjustment algorithm (Period 2). In a dose-response manner, rise in Hb level increase rate per week was observed in the correction group. Decreases in hepcidin and ferritin and increased total iron-binding capacity were observed in association with enarodustat. Also, enarodustat showed generally good tolerability. Overall, in this patient population, enarodustat corrected and maintained Hb levels.
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