Study of Roxadustat (FG-4592) in Participants With End-Stage Renal Disease Receiving Maintenance Hemodialysis

Summary

The primary objective of this study is to evaluate the efficacy and safety of roxadustat in participants with end-stage renal disease (ESRD) on maintenance hemodialysis (HD) therapy, previously treated with intravenous (IV) epoetin alfa.

Timeline

Start

2010-05-17

Primary completion

2012-10-15

Completion

2012-10-15

Outcome

Missed primary endpoint

registry analysis (other test); Cohort A-1 (Roxadustat 1.0 mg/kg TIW) vs Cohort A (Epoetin Alfa); p = 1.0000; Fisher Exact; note: Threshold for significance at 0.05 level. NCT01147666 ↗

registry analysis (other test); Cohort A-2 (Roxadustat 1.5 mg/kg TIW) vs Cohort A (Epoetin Alfa); p = 0.0698; Fisher Exact; note: Threshold for significance at 0.05 level. NCT01147666 ↗

registry analysis (other test); Cohort B-2 (Roxadustat 2.0 mg/kg TIW) vs Cohort B (Placebo); p = 1.0000; Fisher Exact; note: Threshold for significance at 0.05 level. NCT01147666 ↗

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Roxadustat	Small molecule	1 mg/kg	Oral
Subject	Roxadustat	Small molecule	1.3 mg/kg	Oral
Subject	Roxadustat	Small molecule	1.5 mg/kg	Oral
Subject	Roxadustat	Small molecule	1.8 mg/kg	Oral
Subject	Roxadustat	Small molecule	2 mg/kg	Oral
Subject	Roxadustat	Small molecule	70 mg	Oral
Subject	Roxadustat	Small molecule	100 mg	Oral
Subject	Roxadustat	Small molecule	120 mg	Oral
Subject	Roxadustat	Small molecule	150 mg	Oral
Subject	Roxadustat	Small molecule	200 mg	Oral
Comparator	epoetin alfa	Protein / enzyme biologic	—	Intravenous

Indications