Anemia
Conditions
Brief summary
The objective of this study is to evaluate the safety of FCM in patients with anemia who are not dialysis dependent.
Interventions
DRUGFerric Carboxymaltose
15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg.
DRUGIron Dextran
As determined by the investigator to a maximum cumulative dose of 2,250 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
* Subjects ≥18 years of age and able to give informed consent * Iron deficiency is the primary etiology of anemia * History of intolerance or an unsatisfactory response to oral iron * Screening Visit central laboratory Hgb ≤11 g/dL * Screening Visit ferritin ≤100 ng/mL or ≤300 when TSAT was ≤30%
Exclusion criteria
* Previous participation in a FCM trial * Known hypersensitivity reaction to FCM or iron dextran * Requires dialysis for treatment of chronic kidney disease * Current anemia not attributed to iron deficiency * Received IV iron, RBC transfusion(s), or antibiotics 10 days prior and during the screening phase * Anticipated need for surgery during the 30 day period prior to screening or during the study period * AST or ALT greater than 1.5 times the upper limit of normal * Received an investigational drug within 30 days of screening * Women who are breastfeeding * Pregnant or sexually-active females who are not willing to use an effective form of birth control
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Number of Subjects Who Reported Treatment-emergent Adverse Events (AE's) | Day 0 through end of study (Day 42), or 28 days after the last dose of study drug whichever was longer |
Countries
United States
Participant flow
Recruitment details
Hospitals and medical clinics
Pre-assignment details
One subject randomized to iron dextran never received study drug and was discontinued due to subject request.
Participants by arm
| Arm | Count |
|---|---|
| Ferric Carboxymaltose (FCM) 15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg. | 82 |
| Iron Dextran As determined by the investigator to a maximum cumulative dose of 2,250 mg. | 78 |
| Total | 160 |
Baseline characteristics
| Characteristic | Iron Dextran | Ferric Carboxymaltose (FCM) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 15 Participants | 10 Participants | 25 Participants |
| Age, Categorical Between 18 and 65 years | 62 Participants | 72 Participants | 134 Participants |
| Age, Continuous | 48.2 years STANDARD_DEVIATION 17.1 | 46.2 years STANDARD_DEVIATION 14.64 | 47.2 years STANDARD_DEVIATION 15.84 |
| Region of Enrollment United States | 78 participants | 82 participants | 160 participants |
| Sex: Female, Male Female | 69 Participants | 73 Participants | 142 Participants |
| Sex: Female, Male Male | 9 Participants | 9 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 45 / 82 | 54 / 78 |
| serious Total, serious adverse events | 5 / 82 | 3 / 78 |
Outcome results
Primary
The Number of Subjects Who Reported Treatment-emergent Adverse Events (AE's)
Time frame: Day 0 through end of study (Day 42), or 28 days after the last dose of study drug whichever was longer
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ferric Carboxymaltose (FCM) | The Number of Subjects Who Reported Treatment-emergent Adverse Events (AE's) | 60 participants |
| Iron Dextran | The Number of Subjects Who Reported Treatment-emergent Adverse Events (AE's) | 59 participants |