Status:
COMPLETED
Comparison of Oral Iron With IV Iron in Patients With Anemia of Chronic Renal Failure Not on Dialysis
Lead Sponsor:
American Regent, Inc.
Conditions:
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the study was to compare the efficacy of oral iron (ferrous sulfate) plus erythropoietin to Iron Sucrose plus erythropoietin for managing anemia patients with chronic renal failure who ...
Detailed Description
Randomized open-label multicenter active-controlled study of anemic patients with Chronic Renal Failure who are not yet receiving dialysis. The duration of the study was five months. After screening p...
Eligibility Criteria
Inclusion
- Creatine Clearance \<40 mL/min
- Average Baseline Hemoglobin \< 10.5g/dL
- Serum Transferrin Saturation (TSAT) \< 25% and Ferritin \<300ng/mL
Exclusion
- Blood Transfusion within 30days
- Uncontrolled Hypertension
- Suffering form concommitant disease of the liver
- Serious bacterial infection
- Pregnancy / lactation
- Symptomatic HIV
- Expected to under dialysis or renal transplant during study
Key Trial Info
Start Date :
February 23 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2002
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00236964
Start Date
February 23 2001
End Date
May 30 2002
Last Update
May 9 2025
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