Abstract: PO2625
Associations Between Achieved Hemoglobin and Cardiovascular Outcomes in the Pooled Phase 3 Roxadustat Studies of Non-Dialysis-Dependent Patients with Anemia of CKD
Session Information
- Late-Breaking Clinical Trials Posters
October 22, 2020 | Location: On-Demand
Abstract Time: 10:00 AM - 10:00 AM
Category: Anemia and Iron Metabolism
- 200 Anemia and Iron Metabolism
Authors
- Fishbane, Steven, Northwell Health, Great Neck, New York, United States
- Provenzano, Robert, Wayne State University, Detroit, Michigan, United States
- Pergola, Pablo E., Renal Associates, PA, 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 the associations between achieved Hb levels and cardiovascular outcomes in non-dialysis-dependent (NDD) patients with anemia of chronic kidney disease (CKD).
Methods
We analyzed pooled data from 3 pivotal, phase 3 studies of patients with anemia of NDD-CKD who received roxadustat. Incidence rates of adjudicated MACE (all-cause mortality, MI, and stroke) and MACE+ (MACE plus heart failure and 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, 2391 patients were randomized to roxadustat. The mean (SD) baseline Hb of 9.1 (0.74) g/dL increased to 10.95 (0.76) g/dL over weeks 28-52. 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 NDD-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.
Funding
- Commercial Support –