Abstract: PO0453
Effects of Roxadustat in Patients with Dialysis-Dependent CKD (DD-CKD) Across All Baseline (BL) Hemoglobin (Hb) Values
Session Information
- Anemia: Therapies and Iron Metabolism
November 04, 2021 | Location: On-Demand, Virtual Only
Abstract Time: 10:00 AM - 12:00 PM
Category: Anemia and Iron Metabolism
- 200 Anemia and Iron Metabolism
Authors
- Bhandari, Sunil, Hull University Teaching Hospitals NHS Trust, Hull, Kingston upon Hull, United Kingdom
- Pollock, Carol A., The University of Sydney, Sydney, New South Wales, Australia
- 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 efficacy and safety of roxadustat in patients (pts) with DD-CKD across all available BL Hb values.
Methods
Pts were randomized to open-label roxadustat (n=1943) or epoetin alfa (EPO; n=1947) in 3 Phase 3 DD-CKD trials (ROCKIES, SIERRAS, HIMALAYAS). Across trials, Hb eligibility criteria were <10 or 8.5–12 g/dL at final screening. EPO and intravenous (IV) iron were given per local care for the EPO group; for roxadustat, dose was titrated to Hb 11±1 g/dL and IV iron limited to need. 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
Pt study discontinuation rates were similar across BL Hb ranges (Table). Pts with lower BL Hb had less time on dialysis (Table), suggesting pts incident to dialysis. At BL, pts with Hb <9 g/dL had the lowest weekly ESA doses, but by Weeks (wk) 49–52 their weekly ESA doses were highest (Table). Pts with BL Hb <8 g/dL received on average ~1 mg/kg/wk more roxadustat dose at wk 49–52 than pts with BL Hb ≥10 g/dL (Table). Rates of serious AEs (SAEs) and treatment-emergent SAEs per pt-exposure year were comparable for roxadustat vs EPO and appeared more common in pts with higher BL Hb (Table).
Conclusion
DD-CKD pts with more severe anemia at BL required more IV iron during the study. Roxadustat was effective and had comparable tolerability to EPO across all BL Hb studied.
Funding
- Commercial Support –