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/minute intravenously on Day 0.
Per product label
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 * Screening Visit central laboratory Hgb indicative of anemia ≤12 g/dL * Screening Visit ferritin indicative of iron deficiency anemia ≤100 ng/mL or ≤300 when TSAT was ≤30%
Exclusion criteria
* Previous participation in a FCM trial * Known hypersensitivity reaction to FCM * 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 requiring general anesthesia 30 days prior to screening or during the study period * AST of ALT greater than 1.5 times the upper limit of normal * Received an investigational drug within 30 days of screening * Pregnant or sexually-active females who are not able to use an effective form of birth control
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Treatment-emergent Serious Adverse Events (SAE's) | through 30 days after the last dose of study drug (FCM or SMC for the treatment of IDA) |
Countries
United States
Participant flow
Recruitment details
Hospitals and medical clinics
Participants by arm
| Arm | Count |
|---|---|
| Ferric Carboxymaltose (FCM) Subjects receieved an undiluted dose of iron as FCM (15mg/kg up to a maximum of 750 mg) at 100 mg/minute on Day 0. | 366 |
| Standard Medical Care Subjects received standard medical care (as determined by the Investigator) for treatment of IDA. | 369 |
| Total | 735 |
Baseline characteristics
| Characteristic | Standard Medical Care | Ferric Carboxymaltose (FCM) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 6 Participants | 3 Participants | 9 Participants |
| Age, Categorical >=65 years | 98 Participants | 97 Participants | 195 Participants |
| Age, Categorical Between 18 and 65 years | 265 Participants | 266 Participants | 531 Participants |
| Age, Continuous | 49.6 years STANDARD_DEVIATION 19.88 | 49.2 years STANDARD_DEVIATION 19.94 | 49.4 years STANDARD_DEVIATION 19.91 |
| Region of Enrollment United States | 369 participants | 366 participants | 735 participants |
| Sex: Female, Male Female | 315 Participants | 322 Participants | 637 Participants |
| Sex: Female, Male Male | 54 Participants | 44 Participants | 98 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 366 | 0 / 369 |
| serious Total, serious adverse events | 5 / 366 | 9 / 369 |
Outcome results
Primary
Number of Participants With Treatment-emergent Serious Adverse Events (SAE's)
Time frame: through 30 days after the last dose of study drug (FCM or SMC for the treatment of IDA)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ferric Carboxymaltose (FCM) | Number of Participants With Treatment-emergent Serious Adverse Events (SAE's) | 5 participants |
| Standard Medical Care | Number of Participants With Treatment-emergent Serious Adverse Events (SAE's) | 9 participants |