drugset

drugset / Trial / NCT00233597

Ferumoxytol Versus Oral Iron in the Treatment of Anemia in Hemodialysis Patients

NCT00233597 ↗

Phase 3 Completed 230 enrolled AMAG Pharmaceuticals, Inc.

RandomizedParallel-groupOpen-labelTreatment

Summary

The study will evaluate the safety and efficacy of a new intravenously administered iron drug to treat anemia in patients on hemodialysis.

Timeline

Start: 2004-08
Primary completion: —
Completion: 2007-03

Publications

Background Landry R, Jacobs PM, Davis R, Shenouda M, Bolton WK. Pharmacokinetic study of ferumoxytol: a new iron replacement therapy in normal subjects and hemodialysis patients. Am J Nephrol. 2005 Jul-Aug;25(4):400-10. doi: 10.1159/000087212. Epub 2005 Jul 28.
Results Provenzano R, Schiller B, Rao M, Coyne D, Brenner L, Pereira BJ. Ferumoxytol as an intravenous iron replacement therapy in hemodialysis patients. Clin J Am Soc Nephrol. 2009 Feb;4(2):386-93. doi: 10.2215/CJN.02840608. Epub 2009 Jan 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ferumoxytol	Diagnostic / imaging agent	510 mg	Intravenous
Subject	ferumoxytol or oral iron	Unknown	200 mg	Oral

Indications