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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00981045
First received: September 21, 2009
Last updated: October 22, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Iron Deficiency Anemia
Impaired Renal Function
Drug: Ferric Carboxymaltose (FCM)
Drug: Iron Sucrose (Venofer)
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: Randomized Evaluation of Efficacy and Safety of Ferric Carboxymaltose in Patients With Iron Deficiency Anemia and Impaired Renal Function

Resource links provided by NLM:


Further study details as provided by Luitpold Pharmaceuticals:

Primary Outcome Measures:
  • Mean Change From Baseline to the Highest Observed Hemoglobin Any Time From Baseline to End of Study. [ Time Frame: Day 56 ] [ Designated as safety issue: No ]
  • Proportion of Subjects Experiencing at Least One Event in the Primary Composite Safety Endpoint in the Randomized Population. [ Time Frame: Day 120 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 2561
Study Start Date: August 2009
Study Completion Date: August 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT00981045

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

No publications provided

Responsible Party: Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00981045     History of Changes
Other Study ID Numbers: 1VIT09030
Study First Received: September 21, 2009
Results First Received: August 14, 2013
Last Updated: October 22, 2013
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014