NCT00224055

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

A Randomized, Controlled, Open-label Study of the Safety and Efficacy of Ferrlecit® vs Oral Iron in Iron Deficient Patients With Chronic Kidney Disease

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Watson Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Anemia, Iron-Deficiency
• Kidney Failure, Chronic

Interventions

Type	Name	Description
DRUG	Sodium Ferric Gluconate Complex in Sucrose Injection	Sodium Ferric Gluconate Complex in Sucrose Injection (Ferrlecit®), 250 mg IV weekly for 4 weeks
DRUG	Ferrous sulfate tablets	ferrous sulfate, 325 mg oral, three times daily for 6 weeks

Timeline

• Start date: 2003-04-01
• Primary completion: 2004-09-01
• Completion: 2004-09-01
• First posted: 2005-09-22
• Last updated: 2012-03-29
• Results posted: 2012-03-29

Locations

24 sites across 2 countries: United States, Puerto Rico