Comparison of Safety and Efficacy of Intravenous Iron Versus Oral Iron in Chronic Renal Failure Subjects With Anemia

Phase 3 Completed 182 enrolled American Regent, Inc.

RandomizedParallel-groupOpen-labelTreatment

Summary

To assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in non-dialysis dependent, chronic renal failure in patients receiving or not receiving erythropoietin.

Timeline

Start: 2003-08
Primary completion: 2004-10
Completion: 2004-10

Outcome

Met primary endpoint

paper oral iron treatment group (44.3% vs. 28.0%, P= 0.0344) PMID 16316362 ↗

Publications

Results Van Wyck DB, Roppolo M, Martinez CO, Mazey RM, McMurray S; United States Iron Sucrose (Venofer) Clinical Trials Group. A randomized, controlled trial comparing IV iron sucrose to oral iron in anemic patients with nondialysis-dependent CKD. Kidney Int. 2005 Dec;68(6):2846-56. doi: 10.1111/j.1523-1755.2005.00758.x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Ferrous Sulfate	Diagnostic / imaging agent	325 mg	Oral
Subject	Iron sucrose	Unknown	200 mg	Intravenous
Subject	Iron sucrose	Unknown	500 mg	Intravenous