Iron Deficiency Anemia, Impaired Renal Function
Conditions
Keywords
IDA
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.
Interventions
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
Sponsors
American Regent, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline to the Highest Observed Hemoglobin Any Time From Baseline to End of Study. | Day 56 | — |
| Proportion of Subjects Experiencing at Least One Event in the Primary Composite Safety Endpoint in the Randomized Population. | 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. |
Countries
United States
Participant flow
Recruitment details
04-Sept-2009 through 15-Jun-2011; Hospitals and Medical Clinics
Pre-assignment details
14 subjects randomized to FCM and 9 subjects randomized to Venofer were discontinued prior to dosing due to subject request or selection criteria/study compliance reasons.
Participants by arm
| Arm | Count |
|---|---|
| Ferric Carboxymaltose (FCM) 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 | 1,276 |
| Iron Sucrose (Venofer) Iron Sucrose (Venofer) : 5 doses of 200 mg for a total cumulative dose of 1000 mg | 1,285 |
| Total | 2,561 |
Baseline characteristics
| Characteristic | Iron Sucrose (Venofer) | Ferric Carboxymaltose (FCM) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 785 Participants | 808 Participants | 1593 Participants |
| Age, Categorical Between 18 and 65 years | 500 Participants | 468 Participants | 968 Participants |
| Age, Continuous | 67.2 years STANDARD_DEVIATION 13 | 67.5 years STANDARD_DEVIATION 13 | 67.3 years STANDARD_DEVIATION 12.99 |
| Region of Enrollment United States | 1285 participants | 1276 participants | 2561 participants |
| Sex: Female, Male Female | 818 Participants | 810 Participants | 1628 Participants |
| Sex: Female, Male Male | 467 Participants | 466 Participants | 933 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 305 / 1,276 | 151 / 1,285 |
| serious Total, serious adverse events | 202 / 1,276 | 197 / 1,285 |
Outcome results
Primary
Mean Change From Baseline to the Highest Observed Hemoglobin Any Time From Baseline to End of Study.
Time frame: Day 56
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ferric Carboxymaltose (FCM) | Mean Change From Baseline to the Highest Observed Hemoglobin Any Time From Baseline to End of Study. | 1.13 g/dL | Standard Deviation 1.044 |
| Iron Sucrose (Venofer) | Mean Change From Baseline to the Highest Observed Hemoglobin Any Time From Baseline to End of Study. | 0.92 g/dL | Standard Deviation 0.917 |
Primary
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.
Time frame: Day 120
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ferric Carboxymaltose (FCM) | Proportion of Subjects Experiencing at Least One Event in the Primary Composite Safety Endpoint in the Randomized Population. | 175 participants |
| Iron Sucrose (Venofer) | Proportion of Subjects Experiencing at Least One Event in the Primary Composite Safety Endpoint in the Randomized Population. | 156 participants |