Roxadustat for anemia in patients with end-stage renal disease incident to dialysis

Nephrol Dial Transplant. 2021 Aug 27;36(9):1717-1730. doi: 10.1093/ndt/gfab051.


Background: We evaluated the efficacy and safety of roxadustat versus epoetin alfa for the treatment of chronic kidney disease-related anemia in patients new to dialysis.

Methods: HIMALAYAS was a Phase 3, open-label, epoetin alfa-controlled trial. Eligible adults were incident to hemodialysis/peritoneal dialysis for 2 weeks to ≤4 months prior to randomization and had mean hemoglobin (Hb) ≤10.0 g/dL. Primary endpoints were mean Hb (g/dL) change from baseline averaged over Weeks 28-52 regardless of rescue therapy [non-inferiority criterion: lower limit of 95% confidence interval (CI) for treatment difference >-0.75] and percentage of patients achieving an Hb response between Weeks 1 and 24 censored for rescue therapy (non-inferiority margin for between-group difference -15%). Adverse events were monitored.

Results: The intent-to-treat population included patients randomized to roxadustat (n = 522) or epoetin alfa (n = 521). Mean (standard deviation) Hb 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 an Hb response were 88.2% and 84.4% in the roxadustat and epoetin alfa groups, respectively. 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 Hb levels compared with epoetin alfa. Roxadustat had an acceptable safety profile.

Keywords: anemia; dialysis; efficacy; roxadustat, HIF-PHI.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Anemia* / drug therapy
  • Anemia* / etiology
  • Epoetin Alfa / therapeutic use
  • Erythropoietin* / therapeutic use
  • Glycine / analogs & derivatives
  • Hematinics* / therapeutic use
  • Hemoglobins
  • Humans
  • Isoquinolines
  • Kidney Failure, Chronic*
  • Recombinant Proteins
  • Renal Dialysis


  • Hematinics
  • Hemoglobins
  • Isoquinolines
  • Recombinant Proteins
  • Erythropoietin
  • Epoetin Alfa
  • Glycine
  • roxadustat