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
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: 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 August 26, 2014