NCT00233597CompletedPhase 3
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
AMAG Pharmaceuticals, Inc.50 sites in 1 country230 target enrollmentStarted: August 2004Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- AMAG Pharmaceuticals, Inc.
- Enrollment
- 230
- Locations
- 50
- Primary Endpoint
- The mean change in hemoglobin from baseline.
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
The mean change in hemoglobin from baseline.
Secondary Outcomes
- Change in iron indices.
Investigators
Study Sites (50)
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