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Abstract: PO1031

Efficacy and Safety of Roxadustat in Patients with Dialysis-Dependent CKD, Anemia, and Diabetes Mellitus

Session Information

Category: Diabetic Kidney Disease

  • 602 Diabetic Kidney Disease: Clinical

Authors

  • Chan, Tak Mao Daniel, University of Hong Kong, Queen Mary Hospital, Hong Kong SAR, China
  • Pollock, Carol A., The University of Sydney, Sydney, New South Wales, Australia
  • El-Shahawy, Mohamed A., University of Southern California Keck School of Medicine, Los Angeles, California, United States
  • Pergola, Pablo E., Renal Associates PA, San Antonio, Texas, United States
  • Szczech, Lynda, FibroGen Inc, San Francisco, California, United States
  • Saikali, Khalil Georges, FibroGen Inc, San Francisco, California, 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. Diabetes mellitus (DM) is a growing health problem often associated with CKD. The risk of cardiovascular (CV) events and CV mortality is significantly increased in patients with CKD and DM. Thus, evaluation of safety and efficacy of roxadustat in the subgroup of patients with CKD and DM 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 patients with a history of DM at baseline. Efficacy 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, 47% (1830/3890) of patients had DM (roxadustat 915; epoetin alfa 915). Baseline characteristics were generally similar between treatment groups. Mean (SD) Hb levels (g/dL) at baseline were 9.87 (1.15) in the roxadustat group and 9.88 (1.18) in the epoetin alfa group. Patients achieved a significantly larger least-squares mean (LSM) [SEM] CFB in Hb levels (g/dL) with roxadustat vs. epoetin alfa (0.94 [0.032] vs. 0.62 [0.031]), corresponding to a LSM difference of 0.32 (95% CI: 0.23, 0.40) (p<0.0001). Risk for blood/RBC transfusion was significantly reduced in the roxadustat vs. epoetin alfa group (HR, 0.72 [95% CI: 0.56, 0.93]; p=0.0121). Mean (SD) monthly IV iron (mg) use was lower in roxadustat- vs. epoetin alfa-treated patients: 58.0 (222.0) vs. 67.4 (146.5) (p<0.0001). TEAE rates were comparable between treatment groups and to those in the overall DD-CKD study population

Conclusion

Roxadustat was efficacious vs. epoetin alfa for increasing Hb levels, reducing the risk for blood/RBC transfusion, and lowering mean monthly IV iron use in patients with DD-CKD and DM. Safety and tolerability profiles were similar to the overall population and consistent with that observed in this patient subgroup.

Funding

  • Commercial Support –