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

American Regent

Status and phase: Completed; Phase 3

Conditions: Anemia

Treatments: Drug: Ferric Carboxymaltose (FCM); Drug: Standard Medical Care (SMC) for the treatment of IDA

Study type: Interventional

Funder types: Industry

Identifiers

NCT00703937

1VIT08019

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: 708 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
• Screening Visit central laboratory Hemoglobin (Hgb) ≤ 11g/dL
• Screening Visit ferritin ≤ 100ng/mL or ≤ 300 ng/mL when TSAT was ≤ 30%

Exclusion criteria

• 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
• AST or 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 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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708 participants in 2 patient groups

Ferric Carboxymaltose (FCM)

Experimental group

Description:

750 mg of iron as undiluted FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg per minute weekly until the calculated iron deficit dose has been administered (to a maximum cumulative dose of 2,250 mg).

Treatment:

Drug: Ferric Carboxymaltose (FCM)

Standard Medical Care (SMC) for the treatment of IDA

Active Comparator group

Description:

SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA).

Treatment:

Drug: Standard Medical Care (SMC) for the treatment of IDA