Session: 102. Regulation of Iron Metabolism: Poster I
Hematology Disease Topics & Pathways:
Anemias, Adult, Non-Biological, Diseases, Therapies, Biological Processes, Study Population, Clinically relevant, iron metabolism, iron transport
Methods: Patients were randomized to double-blind roxadustat or placebo in 3 pivotal NDD-CKD trials. Oral iron was administered without restriction per discretion of the treating physician, and intravenous (IV) iron use was limited to rescue therapy. Mean changes from baseline (BL) in Hb, hepcidin, and iron parameters were evaluated. Pooled results are reported.
Results: Overall, 4277 patients were evaluated (roxadustat N=2391; placebo N=1886). Mean estimated glomerular filtration rate (eGFR) was 20 ml/min/1.73 m2 in both groups. Roxadustat was superior to placebo in increasing mean Hb from BL (9.1 g/dL for both groups) averaged over Weeks 28–52: 1.9 vs 0.2 g/dL (P<0.0001). IV iron use was required in 2.1% of roxadustat vs 4.8% of placebo patients during the first 52 weeks after randomization. Roxadustat reduced hepcidin and increased both transferrin and serum iron (Figure). Reductions in ferritin and transferrin saturation occurred predominantly in patients with the highest BL values of these parameters when assessed by quartile (>328 µg/L and >35%, respectively).
Conclusion: Roxadustat increased both serum iron and iron-carrying capacity (transferrin) while simultaneously inducing erythropoiesis and correcting anemia in patients with NDD-CKD, without the need for regular IV iron supplementation.
Disclosures: Fishbane: Akebia Inc.: Research Funding; Ardelyx: Research Funding; AstraZeneca: Consultancy, Research Funding; MegaPro Biomedical Co Ltd: Research Funding; Cara Therapeutics: Research Funding; Corvidia Therapeutics: Research Funding. Charytan: Akebia: Research Funding; GSK: Research Funding; Fibrogen: Consultancy, Research Funding; AstraZeneca: Consultancy, Research Funding. Little: AstraZeneca: Current Employment, Current equity holder in private company. Tham: AstraZeneca: Current Employment, Current equity holder in private company. Leong: FibroGen Inc.: Current Employment, Current equity holder in private company. Pergola: AstraZeneca: Consultancy, Research Funding.