Kidney Week

Abstract: SU-OR24

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

Session Information

• Peritoneal Dialysis and Vascular Access: Research Abstracts
  October 25, 2020 | Location: Simulive
  Abstract Time: 05:00 PM - 07:00 PM

Category: Dialysis

• 703 Dialysis: Peritoneal Dialysis

Authors

• Chan, Tak Mao Daniel, University of Hong Kong, Queen Mary Hospital, Hong Kong SAR, China

Tak Mao Daniel Chan, MD, FASN



Daniel Tak Mao Chan obtained his MBBS, MD, and DSc degrees from the University of Hong Kong (HKU). He is Chair Professor at the HKU Department of Medicine, Queen Mary Hospital, and Chief of Nephrology for HK West Cluster Hospitals. He is also the Yu Chiu Kwong Endowed Professor in Medicine. He has previously served as President of the Asian Pacific Society of Nephrology (APSN), and is currently Vice-President of Hong Kong College of Physicians. He is recipient of APSN Kenzo Oshima Award. His research interests include 'lupus nephritis' and 'viral hepatitis in patients with kidney diseases'.

• Szczech, Lynda, FibroGen Inc, San Francisco, California, United States

Lynda Szczech,

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

Jayant Kumar,

• Rastogi, Anjay, University of California Los Angeles, Los Angeles, California, United States

Anjay Rastogi,

• Pollock, Carol A., The University of Sydney, Sydney, New South Wales, Australia

Carol A. Pollock,

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

Gopal Saha,

• Lee, Tyson T., FibroGen Inc, San Francisco, California, United States

Tyson T. Lee,

• Pola, Maksym, AstraZeneca, Warsaw, Poland

Maksym Pola,

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