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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00704028
Recruitment Status : Completed
First Posted : June 24, 2008
Results First Posted : November 25, 2013
Last Update Posted : January 12, 2017
Sponsor:
Information provided by (Responsible Party):

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
Primary Completion Date : January 2010
Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron
U.S. FDA Resources

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00704028


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

Responsible Party: Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00704028     History of Changes
Other Study ID Numbers: 1VIT08020
First Posted: June 24, 2008    Key Record Dates
Results First Posted: November 25, 2013
Last Update Posted: January 12, 2017
Last Verified: November 2016

Additional relevant MeSH terms:
Anemia
Anemia, Iron-Deficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Iron
Ferric Compounds
Iron-Dextran Complex
Dextrans
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics
Anticoagulants
Plasma Substitutes
Blood Substitutes