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Evaluation of Efficacy and Safety of Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia and Impaired Renal Function (REPAIR-IDA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00981045
Recruitment Status : Completed
First Posted : September 22, 2009
Results First Posted : October 18, 2013
Last Update Posted : November 15, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The primary objective of this study is to examine the efficacy and safety (cardiovascular) of an investigational intravenous (IV) iron, ferric carboxymaltose (FCM), compared to IV iron sucrose (Venofer) in subjects who have iron deficiency anemia (IDA) and impaired renal function.

Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia Impaired Renal Function Drug: Ferric Carboxymaltose (FCM) Drug: Iron Sucrose (Venofer) Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2561 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Evaluation of Efficacy and Safety of Ferric Carboxymaltose in Patients With Iron Deficiency Anemia and Impaired Renal Function
Study Start Date : August 2009
Primary Completion Date : July 2011
Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Ferric Carboxymaltose (FCM)
2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg
Drug: Ferric Carboxymaltose (FCM)
2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg
Active Comparator: Iron Sucrose (Venofer)
5 doses of 200 mg for a total cumulative dose of 1000 mg
Drug: Iron Sucrose (Venofer)
5 doses of 200 mg for a total cumulative dose of 1000 mg


Outcome Measures

Primary Outcome Measures :
  1. Mean Change From Baseline to the Highest Observed Hemoglobin Any Time From Baseline to End of Study. [ Time Frame: Day 56 ]
  2. Proportion of Subjects Experiencing at Least One Event in the Primary Composite Safety Endpoint in the Randomized Population. [ Time Frame: Day 120 ]
    The primary composite safety endpoint was defined as death due to any cause, nonfatal myocardial infarction, nonfatal stroke, unstable angina requiring hospitalization or medical intervention, arrhythmias, protocol-defined hypersensitive events, and protocol-defined hyposensitive events.


Eligibility Criteria

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
Criteria

Inclusion Criteria:

  • Male or female subjects > or = to 18 years of age.
  • Chronically impaired renal function.
  • Screening visit central laboratory hemoglobin < or = to 11.5 g/dL.
  • Screening ferritin < or = to 100 ng/mL or < or = to 300 when transferrin saturation (TSAT) is < or = to 30%.
  • If on an erythropoiesis stimulating agent(ESA) a stable dose (+/- 20%) for 4 weeks prior to randomization.

Exclusion Criteria:

  • Known hypersensitivity reaction to any component of ferric carboxymaltose (FCM) or Venofer.
  • Previously randomized in a clinical study of Ferric Carboxymaltose (FCM).
  • Requires dialysis for treatment of chronic kidney disease OR is being considered for initiation of dialysis during the time period of this trial.
  • No evidence of iron deficiency.
  • Any non-viral infection.
  • AST or ALT at screening as determined by central labs greater than 1.5 times the upper limit of normal.
  • Known positive hepatitis with evidence of active disease.
  • Received an investigational drug within 30 days of screening.
  • Alcohol or drug abuse within the past 6 months.
  • Hemochromatosis or other iron storage disorders.
  • Estimated life expectancy of less than 6 months, or for cancer patients, an ECOG Performance Status greater than 1.
  • Any other laboratory abnormality, medical condition or psychiatric disorder which in the opinion of the investigator would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements.
  • Pregnant or sexually-active female subjects who are not willing to use an acceptable form of contraception.
Contacts and Locations

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): NCT00981045


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

Responsible Party: Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00981045     History of Changes
Other Study ID Numbers: 1VIT09030
First Posted: September 22, 2009    Key Record Dates
Results First Posted: October 18, 2013
Last Update Posted: November 15, 2013
Last Verified: October 2013

Keywords provided by Luitpold Pharmaceuticals:
IDA

Additional relevant MeSH terms:
Anemia
Anemia, Iron-Deficiency
Deficiency Diseases
Renal Insufficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Malnutrition
Nutrition Disorders
Kidney Diseases
Urologic Diseases
Iron
Ferric oxide, saccharated
Ferric Compounds
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics