NCT00224042

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 52 (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 receiving erythropoietic agents, such as Procrit® and Aranesp®.

Conditions

• Anemia, Iron-Deficiency
• Kidney Failure, Chronic

Interventions

Type	Name	Description
DRUG	Sodium Ferric Gluconate complex in sucrose	Sodium ferric gluconate complex in sucrose, 250 mg IV weekly for 4 doses
DRUG	Ferrous sulfate tablets	ferrous sulfate 325 mg three times daily for 6 weeks

Timeline

• Start date: 2003-04-01
• Primary completion: 2005-05-01
• 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