Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients

Phase 4 Completed 89 enrolled Watson Pharmaceuticals

RandomizedParallel-groupOpen-labelTreatment

Summary

This study compares the effect of Ferrlecit® (a form of intravenous iron) to ferrous sulfate (a form of oral iron) in treating anemia and iron deficiency in chronic kidney disease patients who are not receiving erythropoietic agents (hormones that stimulate the bone marrow to make more red blood cells).

Timeline

Start: 2003-04
Primary completion: 2004-09
Completion: 2004-09

Outcome

Missed primary endpoint

paper CFB in Hgb was similar in the two groups (intravenous iron 0.4 g/dl vs. oral iron 0.2 g/dl, p = n.s.). PMID 17035697 ↗

Publications

Results Agarwal R, Rizkala AR, Bastani B, Kaskas MO, Leehey DJ, Besarab A. A randomized controlled trial of oral versus intravenous iron in chronic kidney disease. Am J Nephrol. 2006;26(5):445-54. doi: 10.1159/000096174. Epub 2006 Oct 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Ferrous Sulfate	Diagnostic / imaging agent	325 mg	Oral
Subject	Sodium Ferric Gluconate Complex	Unknown	250 mg	Intravenous