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Abstract: FR-OR25

Efficacy and Safety of Roxadustat in Patients with Dialysis-Dependent CKD and Anemia on Hemodialysis

Session Information

Category: Dialysis

  • 701 Dialysis: Hemodialysis and Frequent Dialysis

Authors

  • Provenzano, Robert, Wayne State University, Detroit, Michigan, United States
  • Kumar, Jayant, Renal Medicine Associates, Albuquerque, New Mexico, United States
  • Pergola, Pablo E., Renal Associates PA, San Antonio, Texas, United States
  • Pham van, Bui, Truong Dai hoc Y khoa Pham Ngoc Thach, Ho Chi Minh, Ho Chi Minh, Viet Nam
  • Saha, Gopal, FibroGen Inc, San Francisco, California, United States
  • Liu, Cameron S., 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. Dialysis modality in patients with ESRD may impact clinical outcomes and survival. Thus, evaluation of safety and efficacy of roxadustat in patients on hemodialysis (HD) is of clinical importance.

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 on HD. Endpoints evaluated were: mean change from baseline (CFB) in hemoglobin (Hb) averaged over Weeks 28–52 regardless of rescue therapy and Hb CFB averaged over Weeks 28–36 censored for rescue therapy. Safety and tolerability were assessed by reported treatment-emergent adverse events (TEAEs).

Results

In the DD-CKD study population, 90% (3515/3887) of patients were on HD (roxadustat=1761, epoetin alfa=1754). Baseline characteristics were generally similar between treatment groups. Mean (SD) Hb levels (mg/dL) at baseline were 9.64 (1.31) in the roxadustat group and 9.67 (1.31) in the epoetin alfa group. Patients achieved a larger mean (SD) CFB to Weeks 28–52 in Hb with roxadustat vs. epoetin alfa (1.20 [1.49] vs. 0.98 [1.51]), corresponding to a least-squares mean (LSM) difference of 0.25 (95% CI: 0.19, 0.31) (p<0.0001). Patients achieved a larger mean (SD) CFB to Weeks 28–36 in Hb with roxadustat vs. epoetin alfa (1.27 [1.63] vs. 1.02 [1.60]), corresponding to a LSM difference of 0.25 (95% CI: 0.16, 0.33) (p<0.0001). TEAE rates were comparable between treatment groups.

Conclusion

Roxadustat was efficacious vs. epoetin alfa for increasing and maintaining Hb levels in patients with DD-CKD on HD. The safety and tolerability profiles were similar to the overall population and consistent with that observed in this patient subgroup.

Funding

  • Commercial Support