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Abstract: PO2111

Efficacy and Safety of Roxadustat in Patients with Non-Dialysis-Dependent CKD, Anemia, and Heart Failure

Session Information

Category: Hypertension and CVD

  • 1402 Hypertension and CVD: Clinical, Outcomes, and Trials

Authors

  • Roger, Simon D., Renal Research, Gosford, New South Wales, Australia
  • Fishbane, Steven, Northwell Health, Great Neck, New York, United States
  • Pergola, Pablo E., Renal Associates PA, San Antonio, Texas, United States
  • Chou, Willis, FibroGen Inc, San Francisco, California, United States
  • Saikali, Khalil Georges, FibroGen Inc, San Francisco, California, United States
  • Little, Dustin J., AstraZeneca, Gaithersburg, Maryland, United States
  • Yu, Kin-Hung Peony, FibroGen Inc, San Francisco, California, United States
Background

Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that stimulates erythropoiesis and improves iron metabolism. Patients with heart failure (HF) represent an important clinical subgroup of patients with CKD.

Methods

Pooled data from three pivotal, phase 3, randomized, double-blind, placebo-controlled studies of roxadustat for the treatment of anemia in patients with non–dialysis-dependent (NDD) CKD were assessed in the subgroup of patients with a history of NYHA Class I or II HF recorded at baseline. Endpoints were mean change from baseline (CFB) in hemoglobin (Hb) level averaged over Weeks 28–52 regardless of rescue therapy and time to first blood/RBC transfusion in the first 52 weeks. Safety and tolerability were assessed by reported treatment-emergent adverse events (TEAEs).

Results

In the NDD-CKD study population, 13% (569/4277) of patients had HF (roxadustat=312, placebo=257). Baseline characteristics were generally similar between the treatment groups. Mean (SD) Hb levels (g/dL) at baseline were 9.02 (0.86) in the roxadustat group and 9.04 (0.79) in the placebo group. Patients achieved a larger mean (SD) CFB in Hb levels (g/dL) with roxadustat vs. placebo (1.99 [0.99] vs. 0.29 [1.10]), corresponding to a statistically significant least-squares mean difference of 1.75 (95% CI: 1.54, 1.95) (p<0.0001). The risk for blood/RBC transfusion was significantly reduced in the roxadustat vs. placebo group (HR, 0.15 [95% CI: 0.08, 0.27]; p<0.0001). TEAE rates were comparable between treatment groups and similar to those reported in the overall NDD population.

Conclusion

Roxadustat was efficacious vs. placebo for increasing Hb levels and reducing the risk for blood/RBC transfusion in NDD-CKD patients with HF. The safety and tolerability profile was similar to the overall population and consistent with that observed in this patient subgroup.

Funding

  • Commercial Support