Session: 101. Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron: Poster I
Hematology Disease Topics & Pathways:
Anemias, Adult, Diseases, Non-Biological, Therapies, Biological Processes, erythropoiesis, Study Population, Clinically relevant, pharmacology
Methods: Data from 6 completed randomized Phase 3 studies (up to 4y duration) in patients with Stage 3–5 CKD, comparing roxadustat with placebo in NDD-CKD, and with epoetin alfa in DD-CKD were assessed. Risk of first RBC transfusion was evaluated in individual studies and within pooled NDD and DD populations.
Results: In total, 4277 patients with NDD-CKD were evaluated (2391 roxadustat; 1886 placebo). Mean ± SD baseline hemoglobin was 9.10 ± 0.74 g/dL (roxadustat) and 9.10 ± 0.73 g/dL (placebo). The DD-CKD studies comprised 3857 patients (1929 roxadustat; 1928 epoetin alfa). Mean ± SD baseline Hb was 9.63 ± 1.30 g/dL (roxadustat) and 9.67 ± 1.30 (epoetin alfa). Roxadustat reduced the risk of RBC transfusion by 74% versus placebo in NDD patients and by 18% versus epoetin alfa in DD patients (Table 1).
Conclusion: Roxadustat markedly and significantly reduced transfusion risk versus placebo in NDD CKD, and this effect was consistent across trials. Roxadustat also significantly reduced transfusion risk versus epoetin alfa in DD CKD in the pooled analysis, although this varied within trials.
Disclosures: Fishbane: Ardelyx: Research Funding; Corvidia Therapeutics: Research Funding; MegaPro Biomedical Co Ltd: Research Funding; Akebia Inc.: Research Funding; AstraZeneca: Consultancy, Research Funding; Cara Therapeutics: Research Funding. Provenzano: Nephroceuticals: Current equity holder in private company; Vasc Alert: Current equity holder in private company; FibroGen Inc.: Consultancy; DiVita: Consultancy, Current equity holder in private company; AstraZeneca: Consultancy. Rastogi: AstraZeneca: Consultancy, Research Funding; GlaxoSmithKline: Research Funding. Coyne: FibroGen, Inc.: Consultancy. Pecoits-Filho: AstraZeneca: Consultancy; Akebia: Consultancy; Fresenius Medical Care: Research Funding. Charytan: Fibrogen: Consultancy, Research Funding; AstraZeneca: Consultancy, Research Funding; GSK: Research Funding; Akebia: Research Funding. Pola: AstraZeneca: Current Employment, Current equity holder in private company. Poole: FibroGen, Inc.: Current Employment. Saha: FibroGen, Inc.: Current Employment. Chou: FibroGen, Inc.: Current Employment. Lee: FibroGen, Inc.: Current Employment. Yu: FibroGen, Inc.: Current Employment.
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