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

This study has been completed.
Sponsor:
Information provided by:
Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00704028
First received: June 20, 2008
Last updated: February 23, 2011
Last verified: February 2011
History of Changes
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
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:

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

Further study details as provided by Luitpold Pharmaceuticals:

Primary Outcome Measures:
  • Safety and Tolerability [ Time Frame: Days 7, 14, 28, and 42 ] [ Designated as safety issue: Yes ]

Enrollment: 128
Study Start Date: June 2008
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ferric Carboxymaltose (FCM) 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 Drug: Iron Dextran
As determined by the investigator to a maximum cumulative dose of 2,250 mg.
Other Name: Dexferrum

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 indicative of anemia
  • Screening Visit ferritin indicative of iron deficiency anemia

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
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00704028

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

No publications provided

Responsible Party: Marc Tokars, Luitpold Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00704028     History of Changes
Other Study ID Numbers: 1VIT08020
Study First Received: June 20, 2008
Last Updated: February 23, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on June 17, 2013