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Abstract: SA-OR075

Phase 3, Multicenter, Open-Label Study of Intermittent Oral Roxadustat in Peritoneal Dialysis CKD Patients with Anemia

Session Information

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
  • Reusch, Michael, Astellas Pharma Europe B.V., Leiden, Netherlands
  • Ueno, Mai, Astellas Pharma Inc., Tokyo, Japan
Background

Roxadustat is an oral HIF-PHI in late-stage development for treatment of anemia in CKD. This Phase 3 study evaluated the efficacy and safety of roxadustat in Japanese CKD patients on peritoneal dialysis (PD).

Methods

This 24-week, randomized, open-label study enrolled adult, Japanese, anemic CKD patients on PD into two groups based on prior ESA treatment. Patients not treated with ESA (ESA Untreated) were randomized to roxadustat 50mg or 70mg; patients treated with prior ESA (ESA Treated) were switched to roxadustat 70mg or 100mg depending on prior ESA dose. Dose was adjusted throughout the study to maintain a target hemoglobin (Hb) level of 10.0-12.0 g/dL. Efficacy endpoints were maintenance rate of target Hb level at Weeks 18-24, cumulative response rate at the end of treatment (two Hb thresholds, 10.0 g/dL and 10.5 g/dL; and Hb increase, ≥1.0 g/dL), average Hb levels at Weeks 18-24 and its change from baseline, and rate of rise in Hb levels from Week 0 to Week 4. Safety was assessed by occurrence of adverse events (AEs).

Results

56 patients were enrolled (ESA Untreated, n=13; ESA Treated, n=43). Maintenance rates were 92.3% (95% CI: 64.0, 99.8; ESA Untreated) and 74.4% (95% CI: 58.8, 86.5; ESA Treated). Maintenance rates of patients with at least one Hb value at Weeks 18-24 were 92.3% (95% CI: 64.0, 99.8; ESA Untreated) and 86.5% (95% CI: 71.2, 95.5; ESA Treated). In the ESA Untreated Group, cumulative response rate for both Hb thresholds was 100%. Mean of average Hb levels at Weeks 18-24 were 11.05 g/dL (95% CI: 10.67, 11.42; ESA Untreated) and 10.93 g/dL (95% CI: 10.73, 11.13; ESA Treated); mean change in average Hb at Weeks 18–24 from baseline was 1.69 g/dL (95% CI: 1.06, 2.33; ESA Untreated) and 0.14 g/dL (95% CI: −0.12, 0.39; ESA Treated). In the ESA Untreated Group, mean (SD) rate of rise in Hb levels from Week 0 to Week 4 was 0.193 (0.203) and 0.556 (0.408) g/dL/week with roxadustat 50mg and 70mg, respectively. The most common AEs were nasopharyngitis, back pain, catheter site infection, diarrhea, vomiting, abdominal pain, conjunctivitis, constipation, nausea, and pruritus.

Conclusion

Roxadustat was well tolerated and effective in achieving and maintaining Hb levels within the target range in Japanese CKD patients on PD previously treated or untreated with ESA.

Funding

  • Commercial Support