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Abstract: TH-OR02

Roxadustat for the Treatment of Anemia in CKD Patients Not on Dialysis (NDD): A Phase 3, Randomized, Open-Label, Active-Controlled Study

Session Information

Category: Anemia and Iron Metabolism

  • 200 Anemia and Iron Metabolism


  • Barratt, Jonathan, University of Leicester, Leicester, Leicestershire, United Kingdom
  • Andric, Branislav, Health Center Krusevac, Kruševac, Serbia
  • Tataradze, Avtandil, National Center of Urology, Tbilisi, Tbilisi , Georgia
  • Schoemig, Michael, Center of Dialysis and Nephrology, Heilbronn and Neckarsulm, Germany
  • Reusch, Michael, Astellas Pharma Europe B.V., Leiden, Netherlands
  • Valluri, Udaya, Astellas Pharma Europe B.V., Leiden, Netherlands
  • Mariat, Christopher R., CHU St Etienne, Service Nephrologie Dialyse Transplantation, St Etienne, France

Roxadustat is an orally administered hypoxia-inducible factor prolyl hydroxylase inhibitor to treat anemia in adult CKD patients (pts). Efficacy and safety of roxadustat versus darbepoetin alfa (DA) were assessed in NDD CKD pts in a randomized, open-label, active-controlled phase 3 study.


NDD CKD pts with anemia were randomized to roxadustat or DA for up to 2 years. Dose adjustments were permitted to correct and maintain hemoglobin (Hb) within 10–12 g/dL. The primary endpoint was Hb response, defined as Hb ≥11.0 g/dL and Hb increase from baseline (BL) of ≥1.0 g/dL in pts with BL Hb >8.0 g/dL, or an increase of ≥2.0 g/dL in pts with BL Hb ≤8.0 g/dL, during the first 24 weeks of treatment without rescue therapy. Noninferiority of roxadustat to DA was declared if the lower bound of the two-sided 95% confidence interval (CI) for the difference (roxadustat – DA) in proportion of responders was >-0.15. Key secondary endpoints included change in low-density lipoprotein (LDL) cholesterol, time to first IV iron use, change in mean arterial pressure (MAP), and occurrence of hypertension. Treatment-emergent adverse events (TEAEs) were assessed.


Of 616 randomized pts (roxadustat, 323; DA, 293), 424 completed 2 years of treatment (roxadustat, 215; DA, 209). Mean BL Hb was 9.55 g/dL in both groups. In the per protocol set, the proportion of pts who achieved Hb response during the first 24 weeks was 89.5% (roxadustat; n=256/286) and 78.0% (DA; n=213/273), with a difference of 11.51% (95% CI: 5.66%, 17.36%), thereby establishing roxadustat’s noninferiority to DA. Noninferiority of roxadustat to DA was demonstrated for MAP and time to occurrence of hypertension. Superiority of roxadustat to DA was demonstrated for decreasing LDL cholesterol (p<0.001) and increasing time to first IV iron use (p=0.004). The incidence of TEAEs was comparable between roxadustat (91.6%) and DA (92.5%). Common TEAEs in both groups were end-stage renal disease, hypertension, decreased eGFR, and peripheral edema.


Roxadustat was noninferior to DA for Hb response during the first 24 weeks of treatment in NDD CKD pts. Safety profiles were comparable between groups.


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