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

American Regent

Status and phase: Completed; Phase 3

Conditions: Anemia

Treatments: Drug: Ferric Carboxymaltose; Drug: Iron Dextran

Study type: Interventional

Funder types: Industry

Identifiers

NCT00704028

1VIT08020

Details and patient eligibility

About

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

Enrollment: 161 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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%

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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161 participants in 2 patient groups

Ferric Carboxymaltose (FCM)

Experimental group

Description:

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.

Treatment:

Drug: Ferric Carboxymaltose

Iron Dextran

Active Comparator group

Description:

As determined by the investigator to a maximum cumulative dose of 2,250 mg.

Treatment:

Drug: Iron Dextran