Study to Evaluate the Efficacy and Safety of Roxadustat in the Treatment of Anemia in Participants With ESRD on Stable Dialysis

Summary

The primary objective of this study is to evaluate the efficacy and safety of roxadustat compared with active control (epoetin alfa) for the maintenance treatment of anemia in participants with ESRD on dialysis.

Timeline

Start

2015-01-15

Primary completion

2018-09-19

Completion

2018-09-19

Outcome

Met primary endpoint

registry analysis (non-inferiority test); Roxadustat vs Epoetin Alfa; p <0.0001; LS Mean Difference 0.48 (95% CI 0.365 to 0.591); ANCOVA NCT02273726 ↗

registry analysis (non-inferiority test); Roxadustat vs Epoetin Alfa; p <0.0001; LS Mean Difference 0.55 (95% CI 0.404 to 0.687); Mixed Models Analysis NCT02273726 ↗

Publications

• Hamano T, Yamaguchi Y, Goto K, Martin S, Jiletcovici A, Dellanna F, Akizawa T, Barratt J. Risk Factors for Thromboembolic Events in Patients With Dialysis-Dependent CKD: Pooled Analysis of Four Global Roxadustat Phase 3 Trials. Adv Ther. 2024 Apr;41(4):1553-1575. doi: 10.1007/s12325-023-02728-2. Epub 2024 Feb 16.
• Barratt J, Dellanna F, Portoles J, Choukroun G, De Nicola L, Young J, Dimkovic N, Reusch M. Safety of Roxadustat Versus Erythropoiesis-Stimulating Agents in Patients with Anemia of Non-dialysis-Dependent or Incident-to-Dialysis Chronic Kidney Disease: Pooled Analysis of Four Phase 3 Studies. Adv Ther. 2023 Apr;40(4):1546-1559. doi: 10.1007/s12325-023-02433-0. Epub 2023 Feb 7.
• Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Roxadustat	Small molecule	—	Oral
Comparator	epoetin alfa	Protein / enzyme biologic	—	Intravenous

Indications

No indication recorded.