Efficacy and Safety of Venofer (Iron Sucrose Injection USP) in Patients Receiving Peritoneal Dialysis

Phase 3 Completed 121 enrolled American Regent, Inc.

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a open-label, prospective study comparing intravenous (IV) iron supplementation to standard care in anemic patents undergoing peritoneal dialysis.

Timeline

Start: 2002-07
Primary completion: 2004-09
Completion: 2004-10

Publications

Background Singh H, Reed J, Noble S, Cangiano JL, Van Wyck DB; United States Iron Sucrose (Venofer) Clinical Trials Group. Effect of intravenous iron sucrose in peritoneal dialysis patients who receive erythropoiesis-stimulating agents for anemia: a randomized, controlled trial. Clin J Am Soc Nephrol. 2006 May;1(3):475-82. doi: 10.2215/CJN.01541005. Epub 2006 Mar 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Iron sucrose	Unknown	300 mg	Intravenous
Background	epoetin alfa	Protein / enzyme biologic	—	—

Efficacy and Safety of Venofer (Iron Sucrose Injection USP) in Patients Receiving Peritoneal Dialysis

Summary

Timeline

Publications

Drugs

Indications