Status:
COMPLETED
Safety and Tolerability of a Single Dose of FCM vs. Standard of Care in Treating Iron Deficiency Anemia
Lead Sponsor:
American Regent, Inc.
Conditions:
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The objective of this study is to evaluate the safety of FCM in patients with anemia who are not dialysis dependent
Eligibility Criteria
Inclusion
- Subjects ≥18 years of age and able to give informed consent
- Iron deficiency is the primary etiology of anemia
- Screening Visit central laboratory Hgb indicative of anemia ≤12 g/dL
- Screening Visit ferritin indicative of iron deficiency anemia ≤100 ng/mL or ≤300 when TSAT was ≤30%
Exclusion
- Previous participation in a FCM trial
- Known hypersensitivity reaction to FCM
- Requires dialysis for treatment of chronic kidney disease
- Current anemia not attributed to iron deficiency
- Received IV iron, RBC transfusion(s), or antibiotics 10 days prior and during the screening phase
- Anticipated need for surgery requiring general anesthesia 30 days prior to screening or during the study period
- AST of ALT greater than 1.5 times the upper limit of normal
- Received an investigational drug within 30 days of screening
- Pregnant or sexually-active females who are not able to use an effective form of birth control
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
735 Patients enrolled
Trial Details
Trial ID
NCT00704353
Start Date
June 1 2008
End Date
March 1 2011
Last Update
February 20 2018
Active Locations (1)
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1
Luitpold Pharmaceuticals
Norristown, Pennsylvania, United States, 19403