Background Roxadustat, an orally administered hypoxia-inducible factor prolyl hydroxylase
inhibitor, is being evaluated for treatment of anaemia of chronic kidney disease (CKD).
Methods This randomized, open-label, active-controlled Phase 3 study compared roxadustat
versus darbepoetin alfa (DA) in non-dialysis-dependent (NDD) CKD patients with anaemia
for≤ 104 weeks. Doses were titrated to correct and maintain haemoglobin (Hb) within 10.0–
12.0 g/dL. The primary endpoint was Hb response in the full analysis set, defined as Hb≥ …

Background Roxadustat is an orally active hypoxia-inducible factor prolyl hydroxylase
inhibitor for the treatment of chronic kidney disease (CKD) anemia. Methods This Phase 3,
multicenter, randomized, double-blind, placebo-controlled study examined patients with
Stages 3–5 CKD, not on dialysis (NCT01887600). Patients were randomized (2: 1) to oral
roxadustat or placebo three times weekly for 52–104 weeks. This study examined two
primary efficacy endpoints: European Union (European Medicines Agency)—hemoglobin …