Status:
COMPLETED
Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia (IDA)
Lead Sponsor:
American Regent, Inc.
Conditions:
Iron Deficiency Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The main objective of this study is to demonstrate the efficacy and safety of an investigational intravenous (IV) iron, ferric carboxymaltose (FCM), compared to oral iron in subjects who have iron def...
Eligibility Criteria
Inclusion
- Male or female subjects ≥ to 18 years of age and able to give informed consent.
- Diagnosis of Iron Deficiency Anemia (IDA).
- Hemoglobin (Hgb) ≤ to 11 g/dL.
- Ferritin ≤ to 100 ng/mL or ≤ 300 when Transferrin Saturation (TSAT) was ≤ 30%.
- Must demonstrate an unsatisfactory response or intolerance to oral iron.
Exclusion
- Known hypersensitivity reaction to any component of ferric carboxymaltose or ferrous sulfate.
- Previously randomized in a clinical study of Ferric Carboxymaltose (FCM).
- Requires dialysis for treatment of chronic kidney disease.
- No evidence of iron deficiency.
- Any non-viral infection.
- AST or ALT at screen 1, as determined by central labs, greater than 1.5 times the upper limit of normal.
- Known positive hepatitis with evidence of active disease.
- Received an investigational drug within 30 days of screening.
- Alcohol or drug abuse within the past 6 months.
- Hemochromatosis or other iron storage disorders.
- Estimated life expectancy of less than 6 months or, for cancer patients, an ECOG Performance Status greater than 1.
- Any other laboratory abnormality, medical condition, or psychiatric disorders which in the opinion of the investigator would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements.
- Pregnant or sexually-active females who are of childbearing potential and who are not willing to use an acceptable form of contraception.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
997 Patients enrolled
Trial Details
Trial ID
NCT00982007
Start Date
September 1 2009
End Date
August 1 2011
Last Update
February 20 2018
Active Locations (1)
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1
Luitpold Pharmaceuticals, Inc.
Norristown, Pennsylvania, United States, 19403