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761 Roxadustat Treatment Corrects Anemia to Hemoglobin (Hb) Values ≥10 g/dL in the Majority of Patients with Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD)

Program: Oral and Poster Abstracts
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
Saturday, December 5, 2020, 7:00 AM-3:30 PM

Anjay Rastogi, MD, PhD1*, Roberto Pecoits-Filho2*, Steven Fishbane3*, Dustin Little4*, Elise Hardy4*, Kin-Hung P Yu, MD5* and Robert Provenzano6*

1David Geffen School of Medicine at UCLA, Los Angeles, CA
2Arbor Research Collaborative for Health, Ann Arbor, MI
3Department of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY
4Clinical Research, AstraZeneca, Gaithersburg, MD
5FibroGen Inc., San Francisco, CA
6Department of Nephrology, Hypertension & Transplantation St. John Hospital & Medical Center Detroit, Detroit, MI

Background: The Kidney Disease Improving Global Outcomes (KDIGO) clinical practice guidelines recommend the treatment of anemia in NDD-CKD patients with Hb <10 g/dL to reduce associated symptoms and prevent the need for red blood cell transfusions. Roxadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor studied for the treatment of anemia in patients with CKD through increasing erythropoietin synthesis and enhancing iron utilization. We studied the percentage of patients with NDD-CKD treated with roxadustat achieving Hb 10 g/dL.

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.

*signifies non-member of ASH