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

This study has been completed.
Information provided by (Responsible Party):
Luitpold Pharmaceuticals Identifier:
First received: June 20, 2008
Last updated: September 16, 2013
Last verified: September 2013
The objective of this study is to evaluate the safety of FCM in patients with anemia who are not dialysis dependent.

Condition Intervention Phase
Drug: Ferric Carboxymaltose
Drug: Iron Dextran
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Luitpold Pharmaceuticals:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 161
Study Start Date: June 2008
Study Completion Date: March 2011
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00704028

United States, Pennsylvania
Luitpold Pharmaceuticals
Norristown, Pennsylvania, United States, 19403
Sponsors and Collaborators
Luitpold Pharmaceuticals
  More Information

No publications provided

Responsible Party: Luitpold Pharmaceuticals Identifier: NCT00704028     History of Changes
Other Study ID Numbers: 1VIT08020 
Study First Received: June 20, 2008
Results First Received: September 16, 2013
Last Updated: September 16, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia, Hypochromic
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Ferric Compounds
Iron-Dextran Complex
Blood Substitutes
Growth Substances
Hematologic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Plasma Substitutes
Therapeutic Uses
Trace Elements processed this record on February 07, 2016