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

• ClinicalTrials.gov Identifier: NCT00981045
• Recruitment Status: Completed
• First Posted: September 22, 2009
• Results First Posted: October 18, 2013
• Last Update Posted: February 20, 2018
• Sponsor: American Regent, Inc.
• Information provided by (Responsible Party): American Regent, Inc.

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
• Actual Primary Completion Date: July 2011
• Actual Study Completion Date: August 2011

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

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

Locations

United States, Pennsylvania

Luitpold Pharmaceuticals, Inc.

Norristown, Pennsylvania, United States, 19403

Sponsors and Collaborators

American Regent, Inc.

More Information

• Responsible Party: American Regent, Inc.
• ClinicalTrials.gov Identifier: NCT00981045
• Other Study ID Numbers: 1VIT09030
• First Posted: September 22, 2009
• Results First Posted: October 18, 2013
• Last Update Posted: February 20, 2018
• Last Verified: January 2018

Keywords provided by American Regent, Inc.:

IDA

Additional relevant MeSH terms:

Renal Insufficiency; Anemia; Anemia, Iron-Deficiency; Deficiency Diseases; Hematologic Diseases; Anemia, Hypochromic; Iron Metabolism Disorders; Metabolic Diseases; Malnutrition; Nutrition Disorders; Kidney Diseases; Urologic Diseases; Ferric Oxide, Saccharated; Hematinics