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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00703937
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 (FCM)
Drug: Standard Medical Care (SMC) for the treatment of IDA
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy 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. Standard Medical Care in Treating Iron Deficiency Anemia

Resource links provided by NLM:


Further study details as provided by Luitpold Pharmaceuticals:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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


Enrollment: 708
Study Start Date: July 2008
Study Completion Date: March 2011
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00703937

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: NCT00703937     History of Changes
Other Study ID Numbers: 1VIT08019
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
Deficiency Diseases
Anemia, Iron-Deficiency
Hematologic Diseases
Malnutrition
Nutrition Disorders
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Ferric Compounds
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014