Session: 101. Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron: Poster I
Hematology Disease Topics & Pathways:
Adult, Anemias, Diseases, Non-Biological, Therapies, Biological Processes, Study Population, erythropoiesis, Clinically relevant
Methods: Patients with Hb <10 g/dL and estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 were randomized to roxadustat or placebo in 3 pivotal double-blind NDD-CKD trials (OLYMPUS, ANDES and ALPS). The cumulative percentage of patients with Hb ≥10 g/dL for at least 2 consecutive visits was analyzed monthly over 12 months of roxadustat treatment, using the number of patients remaining on roxadustat treatment at each time point as the denominator. Hb values were censored for 6 weeks following rescue therapy.
Results: In total, 2391 patients received roxadustat. Mean Hb at baseline was 9.1 g/dL and mean eGFR was 19.7 mL/min/1.73 m2. Among patients still on roxadustat treatment, the cumulative percentage of patients with Hb ≥10 g/dL for at least two consecutive visits was 38.3%, 75.5%, and 87.0% at months 1, 2, and 3, respectively, and 96.4% at month 6 (Figure). Among patients still receiving roxadustat treatment at 12 months, the cumulative percentage with confirmed Hb ≥10 g/dL was 99.0%.
Conclusion: Roxadustat effectively raised Hb levels in NDD-CKD patients, with over 95% of patients achieving Hb ≥10 g/dL after 5 months of treatment.
Disclosures: Rastogi: AstraZeneca: Consultancy, Research Funding; GlaxoSmithKline: Research Funding. Pecoits-Filho: AstraZeneca: Consultancy; Akebia: Consultancy; Fresenius Medical Care: Research Funding. Fishbane: AstraZeneca: Consultancy, Research Funding; Akebia Inc.: Research Funding; Cara Therapeutics: Research Funding; MegaPro Biomedical Co Ltd: Research Funding; Ardelyx: Research Funding; Corvidia Therapeutics: Research Funding. Little: AstraZeneca: Current Employment, Current equity holder in private company. Hardy: AstraZeneca: Current Employment, Current equity holder in private company. Yu: FibroGen Inc.: Current Employment, Current equity holder in private company. Provenzano: FibroGen Inc.: Consultancy; AstraZeneca: Consultancy; DiVita: Consultancy, Current equity holder in private company; Nephroceuticals: Current equity holder in private company; Vasc Alert: Current equity holder in private company.
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