Safety and Tolerability of Ferric Carboxymaltose (FCM) Versus Iron Dextran in Treating Iron Deficiency Anemia
NCT ID: NCT00704028
Last Updated: 2018-02-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
161 participants
INTERVENTIONAL
2008-06-30
2011-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ferric Carboxymaltose (FCM)
15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg.
Ferric Carboxymaltose
15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg.
Iron Dextran
As determined by the investigator to a maximum cumulative dose of 2,250 mg.
Iron Dextran
As determined by the investigator to a maximum cumulative dose of 2,250 mg.
Interventions
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Ferric Carboxymaltose
15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg.
Iron Dextran
As determined by the investigator to a maximum cumulative dose of 2,250 mg.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Iron deficiency is the primary etiology of anemia
* History of intolerance or an unsatisfactory response to oral iron
* Screening Visit central laboratory Hgb ≤11 g/dL
* Screening Visit ferritin ≤100 ng/mL or ≤300 when TSAT was ≤30%
Exclusion Criteria
* Known hypersensitivity reaction to FCM or iron dextran
* 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 during the 30 day period prior to screening or during the study period
* AST or ALT greater than 1.5 times the upper limit of normal
* Received an investigational drug within 30 days of screening
* Women who are breastfeeding
* Pregnant or sexually-active females who are not willing to use an effective form of birth control
18 Years
ALL
No
Sponsors
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American Regent, Inc.
INDUSTRY
Responsible Party
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Locations
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Luitpold Pharmaceuticals
Norristown, Pennsylvania, United States
Countries
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Other Identifiers
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1VIT08020
Identifier Type: -
Identifier Source: org_study_id
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