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Kidney Week

Abstract: SU-OR24

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

Session Information

Category: Dialysis

  • 703 Dialysis: Peritoneal Dialysis

Authors

  • Chan, Tak Mao Daniel, University of Hong Kong, Queen Mary Hospital, Hong Kong SAR, China
  • Szczech, Lynda, FibroGen Inc, San Francisco, California, United States
  • Kumar, Jayant, Renal Medicine Associates, Albuquerque, New Mexico, United States
  • Rastogi, Anjay, University of California Los Angeles, Los Angeles, California, United States
  • Pollock, Carol A., The University of Sydney, Sydney, New South Wales, Australia
  • Saha, Gopal, FibroGen Inc, San Francisco, California, United States
  • Lee, Tyson T., FibroGen Inc, San Francisco, California, United States
  • Pola, Maksym, AstraZeneca, Warsaw, Poland
  • 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 is associated with different incidence rates of anemia and clinical outcomes. Therefore, evaluating the safety and efficacy of roxadustat in patients with dialysis-dependent (DD) CKD on peritoneal dialysis (PD) 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 DD-CKD were assessed in the subgroup of patients on PD. Endpoints evaluated were: mean change from baseline (CFB) in hemoglobin (Hb) averaged over Weeks 28–52 regardless of rescue therapy, Hb CFB averaged over Weeks 28–36 censored for rescue therapy, and risk for blood/RBC transfusion during the treatment period. Safety and tolerability were assessed by reported treatment-emergent adverse events (TEAEs).

Results

In the DD-CKD study population, 10% (372/3887) of patients were on PD (roxadustat=180, epoetin alfa=192). Baseline characteristics were generally similar between treatment groups. Mean (SD) Hb levels (g/dL) at baseline were 9.58 (1.22) in the roxadustat group and 9.56 (1.23) in the epoetin alfa group. Patients achieved a larger mean (SD) CFB to Weeks 28–52 in Hb (g/dL) with roxadustat vs. epoetin alfa (1.41 [1.45] vs. 1.08 [1.53]), corresponding to a least-squares mean (LSM) treatment difference of 0.37 (95% CI: 0.11, 0.63) (p=0.0048). Patients achieved a larger mean (SD) CFB to Weeks 28–36 in Hb (g/dL) with roxadustat vs. epoetin alfa (1.53 [1.54] vs. 1.01 [1.63]), corresponding to a LSM treatment difference of 0.46 (95% CI: 0.17, 0.74) (p=0.0018). Risk for blood/RBC transfusion was significantly reduced with roxadustat vs. epoetin alfa (HR, 0.50 [95% CI: 0.26, 0.98]; p=0.0422). TEAE rates were comparable between treatment groups.

Conclusion

Roxadustat was efficacious vs. epoetin alfa for increasing/maintaining Hb levels and reducing the risk for blood/RBC transfusion in patients with DD-CKD on PD. Safety and tolerability profiles were similar to the overall population and consistent with that observed in this patient subgroup.

Funding

  • Commercial Support