Back to resultsEvaluation of Efficacy and Safety of Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia and Impaired Renal Function (REPAIR-IDA)
Primary Purpose
Iron Deficiency Anemia, Impaired Renal Function
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ferric Carboxymaltose (FCM)
Iron Sucrose (Venofer)
Sponsored by
About this trial
This is an interventional treatment trial for Iron Deficiency Anemia focused on measuring IDA
Eligibility 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.
Sites / Locations
- Luitpold Pharmaceuticals, Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ferric Carboxymaltose (FCM)
Iron Sucrose (Venofer)
Arm Description
2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg
5 doses of 200 mg for a total cumulative dose of 1000 mg
Outcomes
Primary Outcome Measures
Mean Change From Baseline to the Highest Observed Hemoglobin Any Time From Baseline to End of Study.
Proportion of Subjects Experiencing at Least One Event in the Primary Composite Safety Endpoint in the Randomized Population.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00981045
First Posted
September 21, 2009
Last Updated
January 22, 2018
Sponsor
American Regent, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00981045
Brief Title
Evaluation of Efficacy and Safety of Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia and Impaired Renal Function
Acronym
REPAIR-IDA
Official Title
Randomized Evaluation of Efficacy and Safety of Ferric Carboxymaltose in Patients With Iron Deficiency Anemia and Impaired Renal Function
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
American Regent, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia, Impaired Renal Function
Keywords
IDA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2561 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ferric Carboxymaltose (FCM)
Arm Type
Experimental
Arm Description
2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg
Arm Title
Iron Sucrose (Venofer)
Arm Type
Active Comparator
Arm Description
5 doses of 200 mg for a total cumulative dose of 1000 mg
Intervention Type
Drug
Intervention Name(s)
Ferric Carboxymaltose (FCM)
Intervention Description
2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg
Intervention Type
Drug
Intervention Name(s)
Iron Sucrose (Venofer)
Intervention Description
5 doses of 200 mg for a total cumulative dose of 1000 mg
Primary Outcome Measure Information:
Title
Mean Change From Baseline to the Highest Observed Hemoglobin Any Time From Baseline to End of Study.
Time Frame
Day 56
Title
Proportion of Subjects Experiencing at Least One Event in the Primary Composite Safety Endpoint in the Randomized Population.
Description
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.
Time Frame
Day 120
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Luitpold Pharmaceuticals, Inc.
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19403
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Efficacy and Safety of Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia and Impaired Renal Function
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