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Kidney Week

Abstract: PO1032

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

Session Information

Category: Diabetic Kidney Disease

  • 602 Diabetic Kidney Disease: Clinical

Authors

  • Roger, Simon D., Renal Research, Gosford, New South Wales, Australia
  • 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
  • Chou, Willis, 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. In patients with DM, 37.0% have CKD (Stages 1–4), of which 52.5% have moderate-to-severe CKD (State 3 or 4). The risk of cardiovascular events and mortality is significantly increased in patients with CKD and DM. Thus, evaluation of the safety and efficacy of roxadustat in patients with CKD and DM is of clinical importance.

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 DM at baseline. Primary and key secondary endpoints were mean change from baseline (CFB) in hemoglobin (Hb) averaged over Weeks 28–52 regardless of rescue therapy and time to first blood/RBC transfusion in the first 52 weeks, respectively. Safety and tolerability were assessed by reported treatment-emergent adverse events (TEAEs).

Results

In the NDD-CKD study population, 57% (2433/4277) of patients had DM (roxadustat=1337, placebo=1096). Baseline characteristics were generally similar between the treatment groups. Mean (SD) Hb levels (g/dL) at baseline were 9.12 (0.71) in the roxadustat group and 9.10 (0.71) in the placebo group. Patients achieved a larger mean (SD) CFB in Hb levels (g/dL) with roxadustat vs. placebo (1.81 [0.93] vs. 0.14 [0.98]), corresponding to a least-squares mean difference of 1.71 (95% CI: 1.61, 1.81) (p<0.0001). The risk for blood/RBC transfusion was significantly reduced in the roxadustat vs. placebo group (HR, 0.28 [95% CI: 0.21, 0.36]; p<0.0001). TEAE rates were comparable between treatment groups and with 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 patients with NDD-CKD and DM. The safety and tolerability profile was similar to the overall NDD-CKD population.

Funding

  • Commercial Support