Status:
COMPLETED
Ferumoxytol Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease 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 with chronic kidney disease who are not on dialysis.
Detailed Description
This study will evaluate the efficacy and safety of intravenous (IV) ferumoxytol as compared to oral iron in the treatment of anemia in non-dialysis dependent CKD patients. Patients are randomized to ...
Eligibility Criteria
Inclusion
- Male or female patients ≥ 18 years.
- Have chronic kidney disease per K/DOQI guidelines.
- No change in EPO status during study.
- Baseline hemoglobin of ≤ 11.0 g/dl.
Exclusion
- Women who are pregnant or lactating.
- 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 major surgery during the study.
- Patients whose EPO status changes while on study.
- Patients with active infections.
- Recent blood transfusions.
- Patients with any known allergies to iron products.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
304 Patients enrolled
Trial Details
Trial ID
NCT00255437
Start Date
June 1 2004
End Date
November 1 2006
Last Update
January 9 2015
Active Locations (13)
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1
Phoenix, Arizona, United States, 85012
2
Tempe, Arizona, United States, 85284
3
New Haven, Connecticut, United States, 06511
4
Augusta, Georgia, United States, 30901