Iron Deficiency Anemia
Conditions
Brief summary
The primary objective of this study is to assess the safety of an investigational intravenous iron (ferric carboxymaltose \[FCM\]) or an equal dose of iron dextran and explore the mechanism of hypophosphatemia following administration of FCM or that of an equal dose of iron dextran when treating women with iron deficiency anemia due to heavy uterine bleeding (HUB).
Detailed description
To assess the safety of an investigational intravenous iron (ferric carboxymaltose \[FCM\]) or an equal dose of iron dextran and explore the mechanism of hypophosphatemia following administration of FCM or that of an equal dose of iron dextran when treating women with iron deficiency anemia due to heavy uterine bleeding (HUB).
Interventions
15 mg/kg up to a maximum of 1000 mg intravenous diluted in 250 cc normal saline solution administered over 15 minutes on Day 0
Test dose of 25 mg administered over 5 minutes, if no reaction occurs then the remainder of the dose (15 mg/kg or 1000 mg including the test dose) will be administered as per investigator. The infusion must be given only when resuscitative techniques for the treatment of anaphylactic reactions are readily available.
Sponsors
American Regent, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female subjects \> or = to 18 years of age * History of Heavy Uterine Bleeding within the past 6 months * Screening visit central laboratory Hgb \< 12 g/dL * Screening Visit ferritin \< or = to 100 ng/mL or \< or = to 300 when transferrin saturation (TSAT) is \< or = to 30% * Demonstrate the ability to understand the requirements of the study, willingness to abide by study restrictions and to return for the required assessments
Exclusion criteria
* Known hypersensitivity reaction to any component of ferric carboxymaltose or iron dextran * Previously randomized in a clinical study of ferric carboxymaltose * Requires dialysis for treatment of chronic kidney disease * Chronic kidney disease, marked by estimated glomerular filtration rate \< 60 ml/min/1.73m squared * Previous kidney transplant * History of primary hypophosphatemic disorder * Hypophosphatemia \< 2.6 mg/dl * No evidence of iron deficiency * During the 10 day period prior to screening has been treated with intravenous iron * During the 30 day period prior to screening or during the study period has or will be treated with erythropoiesis stimulating agents (ESA) in a regimen that is off label * During the 30 day period prior to screening or during the study period has or will be treated with a red blood cell transfusion, radiotherapy and/or chemotherapy * During the 30 day period prior to screening or during the study period has or will require a surgical procedure that necessitates general anesthesia * Any non-viral infection * Aspartate aminotransferase (AST) or Alanine Aminotransferase (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 * Malignancy history within the past 5 years other than basal or squamous cell skin cancer * Any other laboratory abnormality, medical condition or psychiatric disorders 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 of childbearing potential and who are not willing to use an acceptable form of contraception * Untreated primary hyperparathyroidism * Untreated gastrointestinal malabsorption (e.g., sprue)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Blood Markers | Day 35 | Changes in blood markers of phosphate |
Participant flow
Recruitment details
Hospitals and medical clinics
Pre-assignment details
In the FCM group, reasons for discontinuation prior to dosing included lost to follow-up (5 subjects), subject request (2 subjects), and selection criteria/study compliance (2 subjects). In the iron dextran group, reasons for discontinuation prior to dosing included subject request (4 subjects) and lost to follow-up (1 subject).
Participants by arm
| Arm | Count |
|---|---|
| Ferric Carboxymaltose (FCM) Ferric Carboxymaltose (FCM) : 15 mg/kg up to a maximum of 1000 mg intravenous diluted in 250 cc normal saline solution administered over 15 minutes on Day 0 | 25 |
| Iron Dextran Injection Iron Dextran Injection : Test dose of 25 mg administered over 5 minutes, if no reaction occurs then the remainder of the dose (15 mg/kg or 1000 mg including the test dose) will be administered as per investigator. The infusion must be given only when resuscitative techniques for the treatment of anaphylactic reactions are readily available. | 30 |
| Total | 55 |
Baseline characteristics
| Characteristic | Iron Dextran Injection | Ferric Carboxymaltose (FCM) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 25 Participants | 55 Participants |
| Age, Continuous | 33.7 years STANDARD_DEVIATION 10.72 | 36.8 years STANDARD_DEVIATION 10.26 | 35.1 years STANDARD_DEVIATION 10.54 |
| Region of Enrollment United States | 30 participants | 25 participants | 55 participants |
| Sex: Female, Male Female | 30 Participants | 25 Participants | 55 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 | 12 / 25 | 14 / 30 |
| serious Total, serious adverse events | 0 / 25 | 0 / 30 |
Outcome results
Primary
Changes in Blood Markers
Changes in blood markers of phosphate
Time frame: Day 35
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ferric Carboxymaltose (FCM) | Changes in Blood Markers | -.38 mg/dL | Standard Deviation 0.878 |
| Iron Dextran Injection | Changes in Blood Markers | -.08 mg/dL | Standard Deviation 0.633 |