Kidney Week

Abstract: SA-OR075

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

Session Information

• Improving Dialysis Delivery and Patient Outcomes
  October 27, 2018 | Location: 2, San Diego Convention Center
  Abstract Time: 05:54 PM - 06:06 PM

Category: Anemia and Iron Metabolism

• 202 Anemia and Iron Metabolism: Clinical

Authors

• Akizawa, Tadao, Showa University School of Medicine, Tokyo, Japan

Tadao Akizawa, MD



Prof. Tadao Akizawa, MD, PhD Visiting Prof. Division of Nephrology, Department of Medicine, Showa University School of Medicine Prof. Tadao Akizawa graduated Tokyo Medical and Dental University in 1973, and after a 3-year residency at the University hospital, he moved to the Renal Division, Department of Internal Medicine, Fujigaoka Hospital, Showa University. In 1999, he became Prof. Division of Nephrology and Blood Purification Medicine, Wakayama Medical University. In 2005 he accepted the position of Prof. in Chief, Division of Nephrology, Department of Medicine, Showa University School of Medicine until 2013 and continues scientific activity as a Visiting Prof of that division. In the past he has served as President of Japanese Society for Dialysis Therapy (JSDT), President of International Society of Blood Purification (ISBP), President of International Society for Apheresis (ISFA), and several other positions of academic societies. He is now the President of Japanese Association of Dialysis Physicians. He is also an Editor-In-Chief of Therapeutic Apheresis and Dialysis and a member of Editorial Board of several academic Journals.

• Otsuka, Tetsuro, Astellas Pharma Inc., Tokyo, Japan

Tetsuro Otsuka,

• Reusch, Michael, Astellas Pharma Europe B.V., Leiden, Netherlands

Michael Reusch,

• Ueno, Mai, Astellas Pharma Inc., Tokyo, Japan

Mai Ueno,

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 – Astellas Pharma Inc