NCT00233597

Ferumoxytol Versus Oral Iron in the Treatment of Anemia in Hemodialysis Patients

A Phase III Study of the Safety and Efficacy of Ferumoxytol (Compared With Oral Iron) as an Iron Replacement Therapy in Hemodialysis Patients Who Are Receiving Supplemental EPO Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 230 (planned)
• Sponsor: AMAG Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will evaluate the safety and efficacy of a new intravenously administered iron drug to treat anemia in patients on hemodialysis.

Detailed description

This study will evaluate the efficacy and safety of intravenous (IV) iron (ferumoxytol) as compared to oral iron in the treatment of anemia in hemodialysis patients receiving erythropoietin. Patients are randomized to receive either two doses of 510 mg of intravenous ferumoxytol in sequential dialysis sessions or 200 mg oral elemental iron daily for three weeks.

Conditions

• Anemia

Interventions

Type	Name	Description
DRUG	ferumoxytol or oral iron

Timeline

• Start date: 2004-08-01
• Completion: 2007-03-01
• First posted: 2005-10-06
• Last updated: 2022-04-04

Locations

50 sites across 1 country: United States