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Kidney Week

Abstract: PO0454

Effects of Roxadustat in Patients with Non-Dialysis-Dependent CKD (NDD-CKD) Across All Baseline (BL) Hemoglobin (Hb) Values

Session Information

Category: Anemia and Iron Metabolism

  • 200 Anemia and Iron Metabolism

Authors

  • Pollock, Carol A., The University of Sydney, Sydney, New South Wales, Australia
  • Bhandari, Sunil, Hull University Teaching Hospitals NHS Trust, Hull, Kingston upon Hull, United Kingdom
  • Tham, Stefan, Clinical Research, AstraZeneca, Gothenburg, Sweden
  • Rastogi, Anjay, University of California Los Angeles, Los Angeles, California, United States
Background

Roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, increases Hb by stimulating endogenous erythropoietin synthesis and improving iron bioavailability. This pooled post hoc analysis evaluated the effects of roxadustat in patients (pts) with NDD-CKD across all available BL Hb values.

Methods

Pts were randomized to double-blind roxadustat (n=2391) or placebo (PBO; n=1886) in 3 Phase 3 NDD-CKD trials (OLYMPUS, ALPS, ANDES). Hb eligibility criteria were ≤10 g/dL at final screening, study drug dose was titrated to Hb 11±1 g/dL. Oral iron was administered without restriction; intravenous (IV) iron was limited to rescue therapy (IV iron, red blood cell [RBC] transfusion or ESA). Pooled subgroup analyses were performed by selected Hb values (g/dL: <8.0, ≥8.0–<9.0, ≥9.0–<10, ≥10.0) at BL (mean of up to 4 pre-randomization values) regardless of study rescue therapy use. Adverse events (AEs) were assessed.

Results

Pts with lower BL Hb had higher study discontinuation rates and lower BL eGFR (Table). Across BL Hb ranges over Weeks (wk) 28–52, BL change in Hb and proportion of pts with Hb ≥10 g/dL were greater with roxadustat vs PBO (Table). Pts with BL Hb <8 g/dL were treated with ~2 mg/kg/wk more mean roxadustat dose at wk 49–52 than pts with BL Hb ≥10 g/dL (Table). IV iron or RBC transfusion need was less with roxadustat vs PBO and with higher BL Hb (Table). Lower rates of serious AEs (SAEs) and treatment-emergent SAEs per pt-exposure year were observed with increased BL Hb (Table).

Conclusion

NDD-CKD pts with more severe anemia had worse kidney function, required more treatment including RBC transfusion and experienced more SAEs than pts with less severe anemia. Roxadustat improved anemia vs PBO across all BL Hb studied.

Funding

  • Commercial Support