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

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

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

Summary

Timeline

Publications

Drugs

Indications