Roxadustat in the Treatment of Anemia in Chronic Kidney Disease Patients Not Requiring Dialysis
Summary
This study was conducted to treat anemia in patients with chronic kidney disease. Anemia is a reduced number of red blood cells or hemoglobin. Hemoglobin is important for the transport of oxygen in your blood. The purpose of the study was to see if Roxadustat is both effective and safe as a treatment for anemia in patients with chronic kidney disease.
Timeline
- Start
- 2013-09-03
- Primary completion
- 2017-11-01
- Completion
- 2017-11-01
Outcome
Met primary endpoint
registry NUMBER Roxadustat: 79.2 (74.8 to 83.1) Percentage of Participants NCT01887600 ↗
registry analysis (superiority test); Roxadustat vs Placebo; p <0.001; Odds Ratio (OR) 34.74 (95% CI 20.48 to 58.93); Cochran-Mantel-Haenszel NCT01887600 ↗
registry LEAST_SQUARES_MEAN Roxadustat: 1.992 (1.82 to 2.16) g/dL NCT01887600 ↗
registry analysis (superiority test); Roxadustat vs Placebo; p <0.001; Least squares mean difference 1.692 (95% CI 1.52 to 1.86); ANCOVA NCT01887600 ↗
Publications
- 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.
- Provenzano R, Szczech L, Leong R, Saikali KG, Zhong M, Lee TT, Little DJ, Houser MT, Frison L, Houghton J, Neff TB. Efficacy and Cardiovascular Safety of Roxadustat for Treatment of Anemia in Patients with Non-Dialysis-Dependent CKD: Pooled Results of Three Randomized Clinical Trials. Clin J Am Soc Nephrol. 2021 Aug;16(8):1190-1200. doi: 10.2215/CJN.16191020.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Roxadustat | Small molecule | — | — |
Indications
No indication recorded.