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Kidney Week

Abstract: PO2112

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

Session Information

Category: Hypertension and CVD

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

Authors

  • Coyne, Daniel W., Washington University School of Medicine in Saint Louis, Washington University in Saint Louis School of Medicine, Saint Louis, Missouri, United States
  • Fishbane, Steven, Northwell Health, Great Neck, New York, United States
  • Pergola, Pablo E., Renal Associates PA, San Antonio, Texas, United States
  • Szczech, Lynda, 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
  • 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, open-label, epoetin alfa-controlled studies of roxadustat for the treatment of anemia in patients with dialysis-dependent (DD) CKD were assessed in the subgroup of patients with a history of NYHA Class I or II HF at baseline. Endpoints were: mean change from baseline (CFB) in hemoglobin (Hb) averaged over Weeks 28–52 regardless of rescue therapy, time to first blood/RBC transfusion during the treatment period, and mean monthly IV iron use during weeks 28–52. Safety and tolerability were assessed by reported treatment-emergent adverse events (TEAEs).

Results

In the DD-CKD study population, 25% (991/3890) of patients had HF (roxadustat=499; epoetin alfa=492). Baseline characteristics were generally similar. Mean (SD) Hb levels (g/dL) at baseline were 9.59 (1.30) in the roxadustat group and 9.65 (1.29) in the epoetin alfa group. Patients achieved significantly larger least-squares mean (LSM) [SEM] CFB in Hb levels (g/dL) with roxadustat vs. epoetin alfa (1.24 [0.04] vs. 0.94 [0.04]), corresponding to a LSM difference of 0.29 (95% CI: 0.18, 0.40) (p<0.0001). The hazard ratio for first blood/RBC transfusion during the treatment period in the roxadustat and epoetin alfa groups was 0.76 ([95% CI: 0.54, 1.08]; p=0.1274). Mean (SD) monthly IV iron (mg) use was lower in roxadustat- vs. epoetin alfa-treated patients: 55.8 (288.8) vs. 68.6 (142.7) (p<0.0001). TEAE rates were comparable between treatment groups and similar to those in the overall DD-CKD study population.

Conclusion

Roxadustat was efficacious vs. epoetin alfa for increasing Hb levels and reducing mean monthly IV iron use in DD-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