Status:
COMPLETED
VIT45 Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease
Lead Sponsor:
American Regent, Inc.
Conditions:
Anemia
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
This study compares the efficacy and safety of intravenous (IV) iron (VIT45) versus oral iron (ferrous sulfate) administered to subjects who suffer from anemia and are diagnosed with non-dialysis depe...
Detailed Description
This study compares the efficacy and safety of intravenous (IV) iron (VIT45) versus oral iron (ferrous sulfate) administered to subjects who suffer from anemia and are diagnosed with non-dialysis depe...
Eligibility Criteria
Inclusion
- Males or females \> or = 12 years of age
- NDD-CKD subjects
- Baseline hemoglobin \< or = 11g/dl
- Stable erythropoietin (EPO) status
Exclusion
- Known hypersensitivity to ferrous sulfate or IV iron
- Unstable EPO status
- Anemia not related to CKD
- Chronic, serious infection
- Recent IV iron
- Recent blood transfusion
- Recent blood loss
- Need for surgery
- Received investigational drug within 30 days
- Female subjects who are pregnant or lactating
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
255 Patients enrolled
Trial Details
Trial ID
NCT00317239
Start Date
May 1 2005
End Date
August 1 2007
Last Update
February 20 2018
Active Locations (1)
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1
Luitpold Pharmaceuticals
Norristown, Pennsylvania, United States, 19403