Status:
COMPLETED
Ferumoxytol Versus Oral Iron in the Treatment of Anemia in Hemodialysis Patients
Lead Sponsor:
AMAG Pharmaceuticals, Inc.
Conditions:
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- Male or female patients ≥18 years.
- Chronic hemodialysis.
- Stable supplemental EPO therapy.
- Baseline hemoglobin of ≤ 11.5 g/dl.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT00233597
Start Date
August 1 2004
End Date
March 1 2007
Last Update
April 4 2022
Active Locations (50)
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1
Phoenix, Arizona, United States, 85012
2
Tempe, Arizona, United States, 85284
3
Los Angeles, California, United States, 90073
4
Mountain View, California, United States, 94014