Abstract: SA-PO226
Phase 3, Multicenter, Randomized, Open-Label, Non-Comparative Study of Intermittent Oral Roxadustat in ESA-Naive CKD Patients Not on Dialysis in Japan
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
- Akizawa, Tadao, Showa University School of Medicine, Tokyo, 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, an oral HIF-PHI, is in late-stage development for treatment of chronic kidney disease (CKD) anemia. This phase 3 study evaluated efficacy and safety of oral roxadustat in erythropoiesis stimulating agent (ESA)-naïve non–dialysis-dependent (NDD)-CKD patients with anemia.
Methods
Multicenter, 24-week, Japanese study of NDD-CKD ESA-naïve anemic (hemoglobin [Hb] <10.5 g/dL) patients. Patients were randomized to roxadustat (initial dose of 50 mg or 70 mg) three times weekly; dose was adjusted to maintain Hb at 10-12 g/dL. Efficacy endpoints were response rate (Hb ≥10.0 g/dL and a Hb increase of ≥1.0 g/dL from baseline) at end of treatment; average Hb levels at Weeks 18-24; change of average Hb levels at Weeks 18-24 from baseline; maintenance rate of target Hb level (proportion of patients achieving average Hb level of 10-12 g/dL at Weeks 18-24); rate of rise in Hb (g/dL/week) from Week 0 to Week 4, time of discontinuation before Week 4, or time of dose adjustment before Week 4. Occurrence of adverse events (AEs) was assessed.
Results
Of 100 randomized patients, 99 started on 50 mg (n=49) or 70 mg (n=50) roxadustat. Response rate (95% CI) from baseline to end of treatment was 93.9 (83.1, 98.7) % and 100.0 (92.9, 100.0) % in the 50-mg and 70-mg groups, respectively. Mean (SD) of average Hb levels at Weeks 18-24 was 11.12 (0.57) g/dL and 11.23 (0.67) g/dL in the 50-mg and 70-mg groups, respectively. Mean (SD) change of average Hb levels at Weeks 18-24 from baseline was 1.39 (0.93) and 1.30 (0.80) g/dL in the 50-mg and 70-mg groups, respectively. Maintenance rate (95% CI) of target Hb level during Weeks 18-24 among patients with ≥1 Hb value at Weeks 18-24 was 88.6 (75.4, 96.2) % and 88.9 (75.9, 96.3) %, in the 50-mg and 70-mg groups, respectively. Mean (SD) rate of rise in Hb from Week 0-4 was 0.291 (0.197) g/dL/week and 0.373 (0.235) g/dL/week in the 50-mg and 70-mg groups, respectively. The most common AEs were nasopharyngitis (20.2%), hypertension (6.1%), diarrhea (5.1%), and hyperkalemia (5.1%).
Conclusion
Roxadustat was effective in achieving and maintaining Hb levels with the target range at both starting doses and in Japanese ESA-naïve NDD-CKD patients with a favorable safety profile. The rate of rise of Hb was dose dependent.
Funding
- Commercial Support –