Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia (IDA)

Phase 3

Completed

• Conditions: Iron Deficiency Anemia
• Interventions: Drug: Ferric Carboxymaltose (FCM); Drug: Ferrous Sulfate Tablets; Drug: IV Iron (standard of care)

• Registration Number: NCT00982007
• Lead Sponsor: American Regent, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-21
• Study First Submitted QC: 2009-09-21
• Study First Posted: 2009-09-22
• Primary Completion: 2011-03
• Study Completion: 2011-08
• Results First Submitted: 2013-08-14
• Results First Submitted QC: 2013-08-14
• Results First Posted: 2013-10-18
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-22
• Last Update Posted: 2018-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 997

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.
• Estimated life expectancy of less than 6 months or, for cancer patients, an ECOG Performance Status greater than 1.
• Any other laboratory abnormality, medical condition, or psychiatric disorders which in the opinion of the investigator would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements.
• Pregnant or sexually-active females who are of childbearing potential and who are not willing to use an acceptable form of contraception.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1 (Group A) - Ferric Carboxymaltose (FCM)	Ferric Carboxymaltose (FCM)	Intravenous (IV) iron
Cohort 2 (Group C) - Ferric Carboxymaltose (FCM)	Ferric Carboxymaltose (FCM)	Intravenous (IV) iron
Cohort 1 (Group B) - Ferrous Sulfate	Ferrous Sulfate Tablets	Oral iron - Ferrous Sulfate tablets
Cohort 2 (Group D) - IV Iron (standard of care)	IV Iron (standard of care)	Other IV iron

Primary Outcome Measures

Name	Time	Method
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.	Day 35

Trial Locations

Locations (1)

Luitpold Pharmaceuticals, Inc.; 🇺🇸 Norristown, Pennsylvania, United States