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

NCT ID: NCT00703937

Last Updated: 2018-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 708 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2011-03-31

Brief Summary

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

Conditions

Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ferric Carboxymaltose (FCM)

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).

Group Type: EXPERIMENTAL

Ferric Carboxymaltose (FCM)

Intervention Type: DRUG

Standard Medical Care (SMC) for the treatment of IDA

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

Group Type: ACTIVE_COMPARATOR

Standard Medical Care (SMC) for the treatment of IDA

Intervention Type: DRUG

Interventions

Ferric Carboxymaltose (FCM)

Intervention Type: DRUG

Standard Medical Care (SMC) for the treatment of IDA

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Regent, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Luitpold Pharmaceuticals

Norristown, Pennsylvania, United States

Countries

United States

Other Identifiers

1VIT08019

Identifier Type: -

Identifier Source: org_study_id