Phase 2 Study of Roxadustat in Participants With Anemia and Chronic Kidney Disease Not Requiring Dialysis

Summary

The primary objective of the study is to evaluate the safety, tolerability, and pharmacodynamic effects of different oral doses of roxadustat administered 2 times a week (BIW) or 3 times a week (TIW) for up to 4 weeks to participants with chronic kidney disease (CKD) not requiring dialysis.

Timeline

Start

2006-11-01

Primary completion

2010-06-21

Completion

2010-06-21

Outcome

Met primary endpoint

registry analysis (other test); Roxadustat 1.5 mg/kg BIW vs Placebo; p <0.0001; t-test, 2 sided; note: Threshold for significance at 0.05 level. NCT00761657 ↗

registry analysis (other test); Roxadustat 1.5 mg/kg TIW vs Placebo; p <0.0001; t-test, 2 sided; note: Threshold for significance at 0.05 level. NCT00761657 ↗

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.
• Besarab A, Provenzano R, Hertel J, Zabaneh R, Klaus SJ, Lee T, Leong R, Hemmerich S, Yu KH, Neff TB. Randomized placebo-controlled dose-ranging and pharmacodynamics study of roxadustat (FG-4592) to treat anemia in nondialysis-dependent chronic kidney disease (NDD-CKD) patients. Nephrol Dial Transplant. 2015 Oct;30(10):1665-73. doi: 10.1093/ndt/gfv302. Epub 2015 Aug 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Roxadustat	Small molecule	0.7 mg/kg	Oral
Subject	Roxadustat	Small molecule	1 mg/kg	Oral
Subject	Roxadustat	Small molecule	1.5 mg/kg	Oral
Subject	Roxadustat	Small molecule	2 mg/kg	Oral

Indications