Status:
COMPLETED
Comparison of Safety and Efficacy of Intravenous Iron Versus Oral Iron in Chronic Renal Failure Subjects With Anemia
Lead Sponsor:
American Regent, Inc.
Conditions:
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in non-dialysis dependent, chronic renal failure in patients receiving or not receiving erythropoietin.
Detailed Description
The intent of this study was to assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in non-dialysis dependent, chronic renal failure patients receiving or not recei...
Eligibility Criteria
Inclusion
- Hemoglobin \< or = 11.5 gm/dL
- Stable dose or not receiving EPO
- Renal Anemia
Exclusion
- IV iron with last 6 months
- Chronic infection, malignancy,major surgery within last month
- Blood Transfusion with last two months
- Significant blood loss within last 3 months
- Concomitant sever diseases of the liver
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2004
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT00236977
Start Date
August 1 2003
End Date
October 1 2004
Last Update
October 6 2020
Active Locations (1)
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1
Luitpold Pharmaceuticals
Valley Forge, Pennsylvania, United States, 19403