Study of Roxadustat (FG-4592) to Correct Anemia in Newly Initiated Dialysis Participants Not on Erythropoiesis-Stimulating Agent Treatment

Phase 2 Completed 60 enrolled Kyntra Bio Astellas Pharma Inc · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate efficacy and safety of roxadustat in the correction of anemia in participants with end-stage renal disease who recently started dialysis.

Timeline

Start: 2011-07-21
Primary completion: 2013-01-10
Completion: 2013-01-10

Outcome

Missed primary endpoint

registry Roxadustat Only, No Iron vs Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg; p = 0.0757 NCT01414075 ↗

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	FERROUS GLUCONATE ANHYDROUS	Small molecule	—	Oral
Subject	Ferrous Sulfate	Diagnostic / imaging agent	—	Oral
Subject	Roxadustat	Small molecule	60 mg	Oral
Subject	Roxadustat	Small molecule	100 mg	Oral
Subject	Roxadustat	Small molecule	140 mg	Oral
Subject	ferric gluconate	Unknown	60 mg	Intravenous