Abstract: PO0269
A Phase 3, Multicenter, Randomized, Open-Label, Active Comparator Conversion Study of Roxadustat in Non-Dialysis-Dependent (NDD) Patients with Anemia in CKD
Session Information
- Anemia and Iron Management
October 22, 2020 | Location: On-Demand
Abstract Time: 10:00 AM - 12:00 PM
Category: Anemia and Iron Metabolism
- 200 Anemia and Iron Metabolism
Authors
- Akizawa, Tadao, Showa University School of Medicine, Tokyo, Japan
- Iwasaki, Manabu, Yokohama City University, Yokohama, Kanagawa, Japan
- Otsuka, Tetsuro, Astellas Pharma, Inc., Tokyo, Japan
- Yamaguchi, Yusuke, Astellas Pharma, Inc., Tokyo, Japan
- Reusch, Michael, Astellas Pharma Europe B.V., Leiden, Netherlands
Background
Roxadustat is an orally active hypoxia-inducible factor prolyl hydroxylase inhibitor for the treatment of anemia in CKD. Efficacy and long-term safety of roxadustat was assessed, following conversion from darbepoetin alfa (DA), recombinant human erythropoietin (rHuEPO), or epoetin beta pegol (EBP) to roxadustat, in NDD-CKD patients (pts) with anemia. Noninferiority of roxadustat efficacy against DA was evaluated.
Methods
This study enrolled adult Japanese NDD-CKD pts receiving DA, rHuEPO, or EBP for ≥8 weeks before prescreening. Patients who had used rHuEPO or DA were randomized to receive roxadustat or DA (comparative group [CG]). EBP-using pts were allocated to receive roxadustat (referential group [RG]). The primary endpoint was change in average hemoglobin (Hb) from baseline (BL) at Weeks 18-24. Roxadustat efficacy was confirmed if the 95% CI of average Hb at Weeks 18-24 was within 10-12 g/dL; noninferiority of roxadustat to DA was confirmed if the lower limit of the 95% CI of the difference between roxadustat and DA (CGs) was above -0.75 g/dL. Treatment-emergent adverse events (TEAEs) were assessed.
Results
A total of 262 pts were randomized to CGs and received ≥1 dose of roxadustat (n=131) or DA (n=131); 70 pts were allocated to RG and received ≥1 dose. The mean (95% CI) of average Hb at Weeks 18-24 in roxadustat (CG) was 11.14 (11.01, 11.27) g/dL, confirming the efficacy of roxadustat. The difference between roxadustat and DA (CGs) in the change in average Hb from BL at Weeks 18-24 was -0.07 g/dL (95% CI: -0.23, 0.10), confirming noninferiority of roxadustat to DA. The incidence of TEAEs observed during the 24-week treatment period was 78.6% in roxadustat (CG), 70.2% in DA (CG), and 77.1% in roxadustat (RG). Common TEAEs included nasopharyngitis, CKD, hyperkalemia, and hypertension; rates of these were comparable between groups.
Conclusion
This study confirmed the efficacy of roxadustat after conversion from DA, rHuEPO, or EBP, as well as its noninferiority to DA, in NDD-CKD pts with anemia. The safety profile of roxadustat was consistent with previous reports. A final analysis of this study (including 52-week data) will be presented at the congress.
Funding
- Commercial Support – Astellas Pharma, Inc.