Kidney Week

Abstract: FR-OR25

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

Session Information

• Hemodialysis and Home Hemodialysis: Research Abstracts
  October 23, 2020 | Location: Simulive
  Abstract Time: 05:00 PM - 07:00 PM

Category: Dialysis

• 701 Dialysis: Hemodialysis and Frequent Dialysis

Authors

• Provenzano, Robert, Wayne State University, Detroit, Michigan, United States

Robert Provenzano, MD, FASN



Robert Provenzano, MD, FACP, FASN, is a clinical professor of medicine at Wayne State University School of Medicine in Detroit, where he earned his medical degree. He completed his fellowship training at Henry Ford Hospital and served as the chief of the section of nephrology, hypertension and transplantation and director of nephrology research at St. John Hospital and Medical Center in Detroit.”

• Kumar, Jayant, Renal Medicine Associates, Albuquerque, New Mexico, United States

Jayant Kumar,

• Pergola, Pablo E., Renal Associates PA, San Antonio, Texas, United States

Pablo E. Pergola,

• Pham van, Bui, Truong Dai hoc Y khoa Pham Ngoc Thach, Ho Chi Minh, Ho Chi Minh, Viet Nam

Bui Pham van,

• Saha, Gopal, FibroGen Inc, San Francisco, California, United States

Gopal Saha,

• Liu, Cameron S., FibroGen Inc, San Francisco, California, United States

Cameron S. Liu,

• Little, Dustin J., AstraZeneca, Gaithersburg, Maryland, United States

Dustin J. Little,

• Yu, Kin-Hung Peony, FibroGen Inc, San Francisco, California, United States

Kin-Hung Peony Yu,

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 – Fibrogen, Inc.; AstraZeneca plc; Astellas Pharma Inc.