Safety and Tolerability of Ferric Carboxymaltose (FCM) Versus Iron Dextran in Treating Iron Deficiency Anemia

Completed · Phase 3

Conditions studied: Anemia

In brief

The objective of this study is to evaluate the safety of FCM in patients with anemia who are not dialysis dependent.

Key facts

Study ID

NCT00704028

Run by

American Regent, Inc.

People needed

161

Starts

2008-06-01

Expected to finish

2011-03-01

Last updated by the study team

2018-02-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects ≥18 years of age and able to give informed consent
• 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%

You may not qualify if…

• Previous participation in a FCM trial
• 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

Where it is running

• Luitpold Pharmaceuticals — Norristown, Pennsylvania, United States

Full record on ClinicalTrials.gov

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