Safety and Tolerability of a Single Dose 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:
NCT00704353
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: Standard Medical Care (SMC)
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 a Single Dose of Intravenous Ferric Carboxymaltose (FCM) vs. Standard Medical Care in Treating Iron Deficiency Anemia in Subjects Who Are Not Dialysis Dependent

Resource links provided by NLM:


Further study details as provided by Luitpold Pharmaceuticals:

Primary Outcome Measures:
  • Incidence of Treatment-emergent Serious Adverse Events (SAE's) [ Time Frame: through 30 days after the last dose of study drug (FCM or SMC for the treatment of IDA) ] [ Designated as safety issue: Yes ]

Enrollment: 735
Study Start Date: June 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)
15 mg/kg up to a maximum of 750 mg at 100 mg/minute intravenously on Day 0.
Drug: Ferric Carboxymaltose
15 mg/kg up to a maximum of 750 mg at 100 mg/minute intravenously on Day 0.
Active Comparator: Standard Medical Care
Per product label
Drug: Standard Medical Care (SMC)
Per product label
Other Name: Ferrous Sulfate, Venofer, Ferrlecit, Infed, 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
  • Screening Visit central laboratory Hgb indicative of anemia ≤12 g/dL
  • Screening Visit ferritin indicative of iron deficiency anemia ≤100 ng/mL or ≤300 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 requiring general anesthesia 30 days prior to screening or during the study period
  • 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

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: NCT00704353     History of Changes
Other Study ID Numbers: 1VIT08021
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 14, 2014