A Multi-center, Randomized, Active Controlled Study to Investigate the Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia (IDA)

American Regent, Inc.1 site in 1 country997 target enrollmentSeptember 2009

ConditionsIron Deficiency Anemia

InterventionsFerric Carboxymaltose (FCM)Ferrous Sulfate Tablets IV Iron (standard of care)

DrugsFerric Carboxymaltose (FCM)Ferrous Sulfate Tablets IV Iron (standard of care)

Overview

Phase: Phase 3
Intervention: Ferric Carboxymaltose (FCM)
Conditions: Iron Deficiency Anemia
Sponsor: American Regent, Inc.
Enrollment: 997
Locations: 1
Primary Endpoint: Mean Increase From Baseline to the Highest Observed Hemoglobin Value Between Baseline and Day 35 or Time of Intervention for Patients Taking FCM as Compared to That for Patients Taking Ferrous Sulfate.
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The main objective of this study is to demonstrate the efficacy and safety of an investigational intravenous (IV) iron, ferric carboxymaltose (FCM), compared to oral iron in subjects who have iron deficiency anemia (IDA) and have shown an unsatisfactory response to oral iron.

Registry

clinicaltrials.gov

Start Date

September 2009

End Date

August 2011

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

American Regent, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female subjects ≥ to 18 years of age and able to give informed consent.
•Diagnosis of Iron Deficiency Anemia (IDA).
•Hemoglobin (Hgb) ≤ to 11 g/dL.
•Ferritin ≤ to 100 ng/mL or ≤ 300 when Transferrin Saturation (TSAT) was ≤ 30%.
•Must demonstrate an unsatisfactory response or intolerance to oral iron.

Exclusion Criteria

•Known hypersensitivity reaction to any component of ferric carboxymaltose or ferrous sulfate.
•Previously randomized in a clinical study of Ferric Carboxymaltose (FCM).
•Requires dialysis for treatment of chronic kidney disease.
•No evidence of iron deficiency.
•Any non-viral infection.
•AST or ALT at screen 1, as determined by central labs, greater than 1.5 times the upper limit of normal.
•Known positive hepatitis with evidence of active disease.
•Received an investigational drug within 30 days of screening.
•Alcohol or drug abuse within the past 6 months.
•Hemochromatosis or other iron storage disorders.

Arms & Interventions

Cohort 1 (Group A) - Ferric Carboxymaltose (FCM)

Intravenous (IV) iron

Intervention: Ferric Carboxymaltose (FCM)

Cohort 1 (Group B) - Ferrous Sulfate

Oral iron - Ferrous Sulfate tablets

Intervention: Ferrous Sulfate Tablets

Cohort 2 (Group D) - IV Iron (standard of care)

Other IV iron

Intervention: IV Iron (standard of care)

Cohort 2 (Group C) - Ferric Carboxymaltose (FCM)

Intravenous (IV) iron

Intervention: Ferric Carboxymaltose (FCM)

Outcomes

Primary Outcomes

Mean Increase From Baseline to the Highest Observed Hemoglobin Value Between Baseline and Day 35 or Time of Intervention for Patients Taking FCM as Compared to That for Patients Taking Ferrous Sulfate.

Time Frame: Day 35