Abstract: SA-PO230
An Open-Label Extension Study to Evaluate the Efficacy and Safety of Roxadustat for the Long-Term Maintenance Treatment of Anemia in Dialysis and Non-Dialysis Patients with CKD
Session Information
- Anemia and Iron Metabolism: Clinical
November 09, 2019 | Location: Exhibit Hall, Walter E. Washington Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Anemia and Iron Metabolism
- 202 Anemia and Iron Metabolism: Clinical
Authors
- Sun, Chao H., Nephrology Associates Medical Group, INC, Riverside, California, United States
- Barranco, Elizabeth A., Ponce Maedical School Foundation Inc., Ponce, Puerto Rico, United States
- Poole, Lona, FibroGen, Inc., San Francisco, California, United States
- Eyassu, Meraf, FibroGen, Inc., San Francisco, California, United States
- Liu, Cameron S., FibroGen, Inc., San Francisco, California, United States
- Kline, Donna L., FibroGen, Inc., San Francisco, California, United States
- Neff, Thomas B., 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 via increasing endogenous erythropoietin, and regulates iron metabolism.
Methods
In this open-label, extension study, subjects with dialysis-dependent (DD-CKD) and non-dialysis-dependent chronic kidney disease (NDD-CKD) who have completed the treatment period of a phase 2 roxadustat anemia study in the U.S. were enrolled and treated with roxadustat. Subjects continued to receive roxadustat at the same dose and frequency unless a dose adjustment was required, followed by dose titration to Hb levels. Mean Hb values, total weekly roxadustat doses and dose frequencies over time were evaluated. Safety and tolerability were assessed by adverse events, vital signs, electrocardiogram findings, and clinical laboratory values.
Results
Fifteen subjects with NDD-CKD (n=14) and DD-CKD (n=1) were enrolled and treated. One subject with NDD-CKD who withdrew consent two weeks after enrollment and one other subject with DD-CKD were excluded from the analyses. Among the 13 NDD-CKD patients, mean age was 65.5 years; [range, 38 - 78 years], 61.5% (8/13) were female, and 100% (14/14) were white. Baseline Hb levels averaged 10.2 g/dL; [range, 8.7 - 11.2 g/dL], and eGFR averaged 26.1 mL/min; [range, 7.3 - 48.2 mL/min]. At the time of enrollment, 7.7% (1/13) of subjects were on TIW dosing regimen, 69.2% (9/13) on BIW, and 23.1% (3/13) on QW. Mean follow up was 3.7 years [range, 1.0 - 6.9 years]. Hb levels over time averaged 11.7 g/dL [range, 11.0 - 12.4 g/dL]. At patients’ last dose, 7.7% (1/13) of subjects were on TIW dosing regimen, 69.2% (9/13) on BIW, 15.4% (2/13) on QW, and 7.7% (1/13) were on QOW dosing regimen. The mean total weekly dose of roxadustat was 241.2 mg; [range, 73.7 – 517.9 mg]. The safety and tolerability profiles observed were as expected for this patient population.
Conclusion
In this cohort of patients with NDD-CKD, long-term use of roxadustat for treatment of anemia resulted in continued efficacy in Hb maintenance in all patients with a safety profile consistent with the population of patients under study.
Funding
- Commercial Support – Fibrogen Inc.