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

Phase 3

Completed

• Conditions: Anemia
• Interventions: Drug: Ferric Carboxymaltose; Drug: Iron Dextran

• Registration Number: NCT00704028
• Lead Sponsor: American Regent, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-20
• Study First Submitted QC: 2008-06-23
• Study First Posted: 2008-06-24
• Primary Completion: 2010-01
• Study Completion: 2011-03
• Results First Submitted: 2013-09-16
• Results First Submitted QC: 2013-09-16
• Results First Posted: 2013-11-25
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-22
• Last Update Posted: 2018-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

Inclusion Criteria

• Subjects ≥18 years of age and able to give informed consent
• Iron deficiency is the primary etiology of anemia
• History of intolerance or an unsatisfactory response to oral iron
• Screening Visit central laboratory Hgb ≤11 g/dL
• Screening Visit ferritin ≤100 ng/mL or ≤300 when TSAT was ≤30%

Exclusion Criteria

• Previous participation in a FCM trial
• Known hypersensitivity reaction to FCM or iron dextran
• 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 during the 30 day period prior to screening or during the study period
• AST or ALT greater than 1.5 times the upper limit of normal
• Received an investigational drug within 30 days of screening
• Women who are breastfeeding
• Pregnant or sexually-active females who are not willing to use an effective form of birth control

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ferric Carboxymaltose (FCM)	Ferric Carboxymaltose	15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg.
Iron Dextran	Iron Dextran	As determined by the investigator to a maximum cumulative dose of 2,250 mg.

Primary Outcome Measures

Name	Time	Method
The Number of Subjects Who Reported Treatment-emergent Adverse Events (AE's)	Day 0 through end of study (Day 42), or 28 days after the last dose of study drug whichever was longer

Trial Locations

Locations (1)

Luitpold Pharmaceuticals; 🇺🇸 Norristown, Pennsylvania, United States