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

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AMAG Pharmaceuticals, Inc.
• Treatments: Ferrosoferric Oxide; Iron

Criteria

Inclusion Criteria:

• Male or female patients ≥18 years.

• Chronic hemodialysis.

• Stable supplemental EPO therapy.

• Baseline hemoglobin of ≤ 11.5 g/dl.

Exclusion Criteria:

• Women who are pregnant or who are breast feeding.

• Received another investigational drug or device within 30 days.

• Recent parenteral or oral iron therapy.

• Patients with active GI bleeding or acute bleeding within 4 weeks. Patients that have other causes of anemia.

• Major surgery within 30 days or anticipated or planned surgery during the study.

• Patients with active infections.

• Recent blood transfusions.

• Patients with known allergies to iron products.