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Phase 3, randomized, double-blind, active-comparator (darbepoetin alfa) study of oral roxadustat in CKD patients with anemia on hemodialysis in Japan

Journal of the American Society of Nephrology Jun 06, 2020

Akizawa T, Iwasaki M, Yamaguchi Y, et al. - Researchers assessed roxadustat’s (an oral hypoxia-inducible factor prolyl hydroxylase inhibitor) noninferiority to darbepoetin alfa for hemodialysis-dependent CKD anemia, via this phase 3, 24-week, double-blind, double-dummy study. The Japanese patients were randomized to oral roxadustat three times weekly or to darbepoetin alfa injections once weekly, titrating doses to maintain hemoglobin between 10–12 g/dl. The alteration of average hemoglobin from baseline to weeks 18–24 (Hb18–24) was the primary endpoint. Findings revealed that hemoglobin was maintained within 10–12 g/dl by treating hemodialysis patients with roxadustat. Experts found that roxadustat was noninferior to darbepoetin alfa. The observed treatment-emergent adverse events were shown to be consistent with earlier reports. Nasopharyngitis, shunt stenosis, diarrhea, contusion, and vomiting were common treatment-emergent adverse events.

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