Nephrol Dial Transplant. 2021 Feb 25:gfab051. doi: 10.1093/ndt/gfab051. Online ahead of print.
BACKGROUND: We evaluated the efficacy and safety of roxadustat vs. epoetin alfa for the treatment of chronic kidney disease (CKD) related anemia in patients new to dialysis.
METHODS: This was a phase 3, open-label, epoetin alfa-controlled trial. Eligible adults were on hemodialysis/peritoneal dialysis for ≥2 weeks and ≤4 months before randomization and had mean hemoglobin ≤10.0 g/dL. Primary endpoints were mean hemoglobin (g/dL) change from baseline averaged over weeks 28-52 regardless of rescue therapy (non-inferiority criterion: lower limit of 95% CI for treatment difference > -0.75) and percentage of patients achieving a hemoglobin response between weeks 1-24 censored for rescue therapy (non-inferiority margin for between-group difference: -15%). Adverse events were monitored.
RESULTS: The intention-to-treat population included patients randomized to roxadustat (n = 522) or epoetin alfa (n = 521). Mean (SD) hemoglobin changes from baseline averaged over weeks 28-52 were 2.57 (1.27) and 2.36 (1.21) in the roxadustat and epoetin alfa groups. Roxadustat was non-inferior (least-squares mean difference: 0.18 [95% CI: 0.08, 0.29]) to epoetin alfa. Percentages of patients with a hemoglobin response were 88.2% and 84.4% in the roxadustat and epoetin alfa groups. Roxadustat was non-inferior to epoetin alfa (treatment-group difference: 3.5% [95% CI: -0.7%, 7.7%]). Adverse event rates were comparable between treatment groups.
CONCLUSIONS: Roxadustat was efficacious for correcting and maintaining hemoglobin levels compared to epoetin alfa. Roxadustat had an acceptable safety profile.