Safety and Tolerability of a Single Dose of FCM vs. Standard of Care in Treating Iron Deficiency Anemia

American Regent

Status and phase: Completed; Phase 3

Conditions: Anemia

Treatments: Drug: Ferric Carboxymaltose; Drug: Standard Medical Care (SMC)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00704353

1VIT08021

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: 735 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 Hgb indicative of anemia ≤12 g/dL
• Screening Visit ferritin indicative of iron deficiency anemia ≤100 ng/mL or ≤300 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 requiring general anesthesia 30 days prior to screening or during the study period
• AST of 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 able 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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735 participants in 2 patient groups

Ferric Carboxymaltose (FCM)

Experimental group

Description:

15 mg/kg up to a maximum of 750 mg at 100 mg/minute intravenously on Day 0.

Treatment:

Drug: Ferric Carboxymaltose

Standard Medical Care

Active Comparator group

Description:

Per product label

Treatment:

Drug: Standard Medical Care (SMC)