Status:
COMPLETED
Long Term Safety Study of (VIT45) Extension Study: 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
The primary objective of this study is to evaluate the long term safety and tolerability of an iron maintenance dosing strategy utilizing VIT45 in the treatment of anemia of non-dialysis dependent chr...
Detailed Description
The primary objective of this study is to evaluate the long term safety and tolerability of an iron maintenance dosing strategy utilizing VIT45 in the treatment of anemia of non-dialysis dependent chr...
Eligibility Criteria
Inclusion
- Subjects who completed or discontinued Protocol 1VIT04004
Exclusion
- Known hypersensitivity reaction to VIT-45
- Anemia not related to CKD
- Chronic, serious infection
- Recent IV iron other than study drug in past 12 weeks
- Recent blood loss within the last 12 weeks
- Need for surgery or dialysis
- Female subjects who are pregnant or lactating
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT00317226
Start Date
June 1 2005
End Date
September 1 2007
Last Update
February 20 2018
Active Locations (1)
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1
Luitpold Pharmaceuticals Inc.
Norristown, Pennsylvania, United States, 19403