Anemia
Conditions
Brief summary
The Objective of this study is to study the safety of FCM in patients with anemia caused by Heavy Uterine Bleeding and the Post Partum state.
Interventions
DRUGFerric Carboxymaltose
Sponsors
American Regent, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Female with iron deficiency anemia * Hg \</= 11 g/dL
Exclusion criteria
* Previous participation in a FCM trial * Known Hypersensitivity to FCM * History of anemia other that anemia due to heavy uterine bleeding or the post partum state * current history of GI bleeding * Received IV Iron within the month prior * Anticipated need for surgery * Malignancy history * AST or ALT greater than normal * Received an investigational drug within 30 days of screening * Pregnant or sexually active females who are not willing ot use an effective form of birth control
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the Safety of the Maximum Administered Dose, 15 mg/kg (up to a Maximum 1,000 mg) of FCM Compared to SMC. | From Day 0 through 30 days after the last dose of study drug. | Evaluate the safety of the maximum administered dose, 15 mg/kg (up to a maximum 1,000 mg) of FCM compared to SMC. The primary safety endpoint was the incidence of Serious Adverse Events (SAE's). |
Countries
United States
Participant flow
Recruitment details
Hospitals and medical clinics
Participants by arm
| Arm | Count |
|---|---|
| Ferric Carboxymaltose (FCM) Intravenous (IV) iron | 996 |
| Standard Medical Care (SMC) SMC for postpartum and heavy uterine bleeding subjects with anemia | 1,022 |
| Total | 2,018 |
Baseline characteristics
| Characteristic | Standard Medical Care (SMC) | Ferric Carboxymaltose (FCM) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 27 Participants | 25 Participants | 52 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 995 Participants | 971 Participants | 1966 Participants |
| Age, Continuous | 31.4 years STANDARD_DEVIATION 8.98 | 31.2 years STANDARD_DEVIATION 9.36 | 31.3 years STANDARD_DEVIATION 9.17 |
| Region of Enrollment United States | 1022 participants | 996 participants | 2018 participants |
| Sex: Female, Male Female | 1022 Participants | 996 Participants | 2018 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 996 | 79 / 1,022 |
| serious Total, serious adverse events | 6 / 996 | 22 / 1,022 |
Outcome results
Primary
Evaluate the Safety of the Maximum Administered Dose, 15 mg/kg (up to a Maximum 1,000 mg) of FCM Compared to SMC.
Evaluate the safety of the maximum administered dose, 15 mg/kg (up to a maximum 1,000 mg) of FCM compared to SMC. The primary safety endpoint was the incidence of Serious Adverse Events (SAE's).
Time frame: From Day 0 through 30 days after the last dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ferric Carboxymaltose (FCM) | Evaluate the Safety of the Maximum Administered Dose, 15 mg/kg (up to a Maximum 1,000 mg) of FCM Compared to SMC. | 6 participants |
| Standard Medical Care (SMC) | Evaluate the Safety of the Maximum Administered Dose, 15 mg/kg (up to a Maximum 1,000 mg) of FCM Compared to SMC. | 22 participants |