Oral roxadustat three times weekly in ESA‐naïve and ESA‐converted patients with anemia of chronic kidney disease on hemodialysis: Results from two phase 3 studies

Abstract

Roxadustat is a hypoxia‐inducible factor prolyl hydroxylase inhibitor approved in China for anemia of dialysis‐dependent chronic kidney disease (CKD). Japanese hemodialysis patients with anemia of CKD previously naïve to, or converted from, erythropoiesis‐stimulating agents (ESAs) were enrolled in two open‐label, noncomparative studies of titrated oral roxadustat administered three times weekly. ESA‐naïve patients (n = 75) were randomized to roxadustat (initial dose, 50 or 70 mg) for 24 weeks; ESA‐converted patients (n = 164) were assigned to roxadustat (initial dose, 70 or 100 mg based on prior ESA dose) for 52 weeks. Efficacy outcomes included average hemoglobin (Hb, weeks 18‐24 or 46‐52), change of Hb from baseline to weeks 18 to 24 (ΔHb _18‐24) or weeks 46 to 52 (ΔHb _46‐52), and maintenance rate (proportion of patients who achieved average Hb of 10.0‐12.0 g/dL for weeks 18‐24 or weeks 46‐52). Treatment‐emergent adverse events (TEAEs) were monitored. Mean (SD) Hb was 10.93 (0.79) g/dL (weeks 18‐24) (ESA‐Naïve Study), and 10.93 (0.69; weeks 18‐24) g/dL and 11.11 (0.67; weeks 46‐52) g/dL (ESA‐Converted Study). Mean (SD) ΔHb _18‐24 was 2.26 (1.02) g/dL (ESA‐Naïve Study) and −0.03 (0.90) g/dL (ESA‐Converted Study); mean (SD) ΔHb _46‐52 was 0.12 (0.83) g/dL (ESA‐Converted Study). The overall maintenance rate was 73.0% (54/74) (ESA‐Naïve Study) (weeks 18‐24), and 79.1% (129/163; weeks 18‐24) and 71.2% (116/163; weeks 46‐52) (ESA‐Converted Study). Nasopharyngitis was the most common TEAE. Two deaths, considered unrelated to roxadustat, occurred in the ESA‐Converted Study. Roxadustat effectively corrected and maintained Hb, regardless of previous ESA treatment, in Japanese anemic CKD patients on hemodialysis.