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
DRUGStandard Medical Care (SMC) for the treatment of IDA
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 Hemoglobin (Hgb) ≤ 11g/dL * Screening Visit ferritin ≤ 100ng/mL or ≤ 300 ng/mL 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 * AST or 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 willing to use an effective form of birth control
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety, as Defined by the Occurence of Serious Adverse Events (SAE's), of FCM Compared to SMC | First administration of FCM, or Day 0 for SMC subjects, through end of study (Day 42) or 28 days after the last dose of study drug (FCM or SMC) whichever was longer | Safety, as defined by the occurence of serious adverse events (SAE's), of FCM compared to SMC in the treatment of IDA in subjects who were not dialysis dependent |
Countries
United States
Participant flow
Recruitment details
Hospitals and medical clinics
Pre-assignment details
5 subjects randomized into the trial were discontinued prior to dosing.
Participants by arm
| Arm | Count |
|---|---|
| Ferric Carboxymaltose (FCM) 750 mg of iron as undiluted FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg per minute weekly until the calculated iron deficit dose has been administered (to a maximum cumulative dose of 2,250 mg). | 343 |
| Standard Medical Care (SMC) for the Treatment of IDA SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA). | 360 |
| Total | 703 |
Baseline characteristics
| Characteristic | Standard Medical Care (SMC) for the Treatment of IDA | Ferric Carboxymaltose (FCM) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 3 Participants | 1 Participants | 4 Participants |
| Age, Categorical >=65 years | 70 Participants | 75 Participants | 145 Participants |
| Age, Categorical Between 18 and 65 years | 287 Participants | 267 Participants | 554 Participants |
| Age, Continuous | 47.7 years STANDARD_DEVIATION 17.62 | 49.3 years STANDARD_DEVIATION 18.48 | 48.5 years STANDARD_DEVIATION 18.05 |
| Region of Enrollment United States | 360 participants | 343 participants | 703 participants |
| Sex: Female, Male Female | 318 Participants | 292 Participants | 610 Participants |
| Sex: Female, Male Male | 42 Participants | 51 Participants | 93 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 41 / 343 | 71 / 360 |
| serious Total, serious adverse events | 17 / 343 | 11 / 360 |
Outcome results
Primary
Safety, as Defined by the Occurence of Serious Adverse Events (SAE's), of FCM Compared to SMC
Safety, as defined by the occurence of serious adverse events (SAE's), of FCM compared to SMC in the treatment of IDA in subjects who were not dialysis dependent
Time frame: First administration of FCM, or Day 0 for SMC subjects, through end of study (Day 42) or 28 days after the last dose of study drug (FCM or SMC) whichever was longer
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ferric Carboxymaltose (FCM) | Safety, as Defined by the Occurence of Serious Adverse Events (SAE's), of FCM Compared to SMC | 17 participants |
| Standard Medical Care (SMC) for the Treatment of IDA | Safety, as Defined by the Occurence of Serious Adverse Events (SAE's), of FCM Compared to SMC | 11 participants |