Safety of FCM vs. Standard of Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Post Partum Patients

American Regent

Status and phase: Completed; Phase 3

Conditions: Anemia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00548860

1VIT07017

Details and patient eligibility

About

The Objective of this study is to study the safety of FCM in patients with anemia caused by Heavy Uterine Bleeding and the Post Partum state.

Enrollment: 2,018 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female with iron deficiency anemia
• Hg </= 11 g/dL

Exclusion criteria

• Previous participation in a FCM trial
• Known Hypersensitivity to FCM
• History of anemia other that anemia due to heavy uterine bleeding or the post partum state
• current history of GI bleeding
• Received IV Iron within the month prior
• Anticipated need for surgery
• Malignancy history
• AST or ALT greater than normal
• Received an investigational drug within 30 days of screening
• Pregnant or sexually active females who are not willing ot 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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2,018 participants in 2 patient groups

Ferric Carboxymaltose (FCM)

Experimental group

Description:

Undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg)

Treatment:

Drug: Ferric Carboxymaltose

Standard Medical Care (SMC)

Active Comparator group

Description:

Varied as determined by the Investigator

Treatment:

Drug: Standard Medical Care (SMC)