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Kidney Week

Abstract: PO2626

Associations Between Achieved Hemoglobin and Cardiovascular Outcomes in the Pooled Phase 3 Trials of Roxadustat in Dialysis-Dependent Patients with Anemia of CKD

Session Information

Category: Anemia and Iron Metabolism

  • 200 Anemia and Iron Metabolism

Authors

  • Provenzano, Robert, Wayne State University, Detroit, Michigan, United States
  • Fishbane, Steven, Northwell Health, Great Neck, New York, United States
  • Pergola, Pablo E., Manchester University NHS Foundation Trust, San Antonio, Texas, United States
  • Szczech, Lynda, FibroGen Inc, San Francisco, California, United States
  • Leong, Robert, FibroGen Inc, San Francisco, California, United States
  • Saikali, Khalil Georges, FibroGen Inc, San Francisco, California, United States
  • Zhong, Ming, FibroGen Inc, San Francisco, California, United States
  • Lee, Tyson T., FibroGen Inc, San Francisco, California, United States
  • Little, Dustin J., AstraZeneca, Gaithersburg, Maryland, United States
  • Frison, Lars, AstraZeneca, Molndal, Sweden
  • Houghton, John, AstraZeneca, Gaithersburg, Maryland, United States
  • Yu, Kin-Hung Peony, FibroGen Inc, San Francisco, California, United States
Background

Roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, promotes erythropoiesis and increases bioavailability of iron. In phase 3 studies, roxadustat-treated patients achieved and maintained hemoglobin (Hb) values of 11±1 g/dL. We examined associations between achieved Hb levels and cardiovascular outcomes in patients with anemia of dialysis-dependent (DD) chronic kidney disease (CKD).

Methods

We analyzed pooled data from 3 pivotal, phase 3 studies of roxadustat-treated patients with anemia of DD-CKD. Incidence rates of adjudicated MACE (all-cause mortality, MI, and stroke) and MACE+ (MACE plus heart failure or unstable angina requiring hospitalization) were evaluated based on 1) Hb level immediately before the event and 2) maximum Hb level in the first 12 treatment weeks.

Results

Overall, 1943 patients were randomized to roxadustat. The mean (SD) baseline Hb was 9.63 (1.3) g/dL; from weeks 28-52, it was 10.85 (0.82) g/dL. The MACE and MACE+ rates were highest when Hb was < 8 g/dL decreasing as Hb increased to 11-12 g/dL and ≥12 g/dL (Table).

Conclusion

In the DD-CKD population, roxadustat corrected anemia and maintained Hb to 11±1 g/dL during weeks 28-52. MACE and MACE+ incidence rates were lowest when achieved Hb levels were ≥11g/dL.