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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 (Responsible Party):
Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00704028
First received: June 20, 2008
Last updated: September 16, 2013
Last verified: September 2013
  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
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

  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 ≤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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on November 27, 2014