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

• ClinicalTrials.gov Identifier: NCT00704028
• Recruitment Status: Completed
• First Posted: June 24, 2008
• Results First Posted: November 25, 2013
• Last Update Posted: February 20, 2018
• Sponsor: American Regent, Inc.
• Information provided by (Responsible Party): American Regent, Inc.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Anemia	Drug: Ferric Carboxymaltose; Drug: Iron Dextran	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 161 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multi-Center, Randomized, Controlled Study to Investigate the Safety and Tolerability of Intravenous Ferric Carboxymaltose (FCM) vs. Iron Dextran in Treating Iron Deficiency Anemia
• Study Start Date: June 2008
• Actual Primary Completion Date: January 2010
• Actual Study Completion Date: March 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: Ferric Carboxymaltose (FCM); 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.	Drug: 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.
Active Comparator: Iron Dextran; As determined by the investigator to a maximum cumulative dose of 2,250 mg.	Drug: Iron Dextran; As determined by the investigator to a maximum cumulative dose of 2,250 mg.; Other Name: Dexferrum, INFeD

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Pennsylvania

Luitpold Pharmaceuticals

Norristown, Pennsylvania, United States, 19403

Sponsors and Collaborators

American Regent, Inc.

More Information

• Responsible Party: American Regent, Inc.
• ClinicalTrials.gov Identifier: NCT00704028
• Other Study ID Numbers: 1VIT08020
• First Posted: June 24, 2008
• Results First Posted: November 25, 2013
• Last Update Posted: February 20, 2018
• Last Verified: January 2018

Additional relevant MeSH terms:

Anemia; Anemia, Iron-Deficiency; Hematologic Diseases; Anemia, Hypochromic; Iron Metabolism Disorders; Metabolic Diseases; Dextrans; Iron-Dextran Complex; Anticoagulants; Plasma Substitutes; Blood Substitutes; Hematinics