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

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ClinicalTrials.gov Identifier: NCT00703937
Recruitment Status : Completed
First Posted : June 24, 2008
Results First Posted : November 25, 2013
Last Update Posted : February 20, 2018
Information provided by (Responsible Party):
Luitpold Pharmaceuticals

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 (FCM) Drug: Standard Medical Care (SMC) for the treatment of IDA Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 708 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. Standard Medical Care in Treating Iron Deficiency Anemia
Study Start Date : July 2008
Primary Completion Date : July 2009
Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: Ferric Carboxymaltose (FCM)
750 mg of iron as undiluted FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg per minute weekly until the calculated iron deficit dose has been administered (to a maximum cumulative dose of 2,250 mg).
Drug: Ferric Carboxymaltose (FCM)
Active Comparator: Standard Medical Care (SMC) for the treatment of IDA
SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA).
Drug: Standard Medical Care (SMC) for the treatment of IDA

Primary Outcome Measures :
  1. Safety, as Defined by the Occurence of Serious Adverse Events (SAE's), of FCM Compared to SMC [ Time Frame: First administration of FCM, or Day 0 for SMC subjects, through end of study (Day 42) or 28 days after the last dose of study drug (FCM or SMC) whichever was longer ]
    Safety, as defined by the occurence of serious adverse events (SAE's), of FCM compared to SMC in the treatment of IDA in subjects who were not dialysis dependent

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

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 Hemoglobin (Hgb) ≤ 11g/dL
  • Screening Visit ferritin ≤ 100ng/mL or ≤ 300 ng/mL when TSAT was ≤ 30%

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
  • AST or 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 willing to use an effective form of birth control

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): NCT00703937

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

Responsible Party: Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00703937     History of Changes
Other Study ID Numbers: 1VIT08019
First Posted: June 24, 2008    Key Record Dates
Results First Posted: November 25, 2013
Last Update Posted: February 20, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Ferric Compounds