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Safety and Tolerability of a Single Dose of Ferric Carboxymaltose (FCM) Versus Standard of Care in Treating Iron Deficiency Anemia
This study is currently recruiting participants.
Verified by Luitpold Pharmaceuticals, October 2008
Sponsored by: Luitpold Pharmaceuticals
Information provided by: Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00704353
  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
Phase III

MedlinePlus related topics: Anemia
Drug Information available for: Ferric carboxymaltose
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Official Title: A Multi-Center, Randomized, Controlled Study to Investigate the Safety and Tolerability of a Single Dose of Intravenous Ferric Carboxymaltose (FCM) vs. Standard Medical Care in Treating Iron Deficiency Anemia in Subjects Who Are Not Dialysis Dependent

Further study details as provided by Luitpold Pharmaceuticals:

Primary Outcome Measures:
  • Safety and Tolerability

Study Start Date: June 2008
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Subjects >/18 years of age and able to give informed consent
  • Iron deficiency is the primary etiology of anemia
  • 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
  • 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 requiring general anesthesia
  • AST of ALT greater than 1.5 times the upper limit of normal
  • Received an investigational drug within 30 days of screening
  • Pregnant or sexually-active females who are not able to use an effective form of birth control
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00704353

Contacts
Contact: Todd Koch 610-650-4200 tkoch@lpicrd.com
Contact: Marc Tokars 610-650-4200 mtokars@lpicrd.com

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

Study ID Numbers: 1VIT08021
Study First Received: June 20, 2008
Last Updated: October 15, 2008
ClinicalTrials.gov Identifier: NCT00704353  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Metabolic Diseases
Ferric Compounds
Hematologic Diseases
Anemia
Iron Metabolism Disorders
Metabolic disorder
Iron
Anemia, Iron-Deficiency

Additional relevant MeSH terms:
Hematinics
Therapeutic Uses
Hematologic Agents
Anemia, Hypochromic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009