Iron Deficiency Anemia
Conditions
Keywords
IDA
Brief summary
The main objective of this study is to demonstrate the efficacy and safety of an investigational intravenous (IV) iron, ferric carboxymaltose (FCM), compared to oral iron in subjects who have iron deficiency anemia (IDA) and have shown an unsatisfactory response to oral iron.
Interventions
A total maximum cumulative dose of 1500 mg administered on Days 0 and 7.
325 mg Ferrous Sulfate tablets taken orally three times a day
IV standard of care (other IV iron) per the Investigator's discretion
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
* Male or female subjects ≥ to 18 years of age and able to give informed consent. * Diagnosis of Iron Deficiency Anemia (IDA). * Hemoglobin (Hgb) ≤ to 11 g/dL. * Ferritin ≤ to 100 ng/mL or ≤ 300 when Transferrin Saturation (TSAT) was ≤ 30%. * Must demonstrate an unsatisfactory response or intolerance to oral iron.
Exclusion criteria
* Known hypersensitivity reaction to any component of ferric carboxymaltose or ferrous sulfate. * Previously randomized in a clinical study of Ferric Carboxymaltose (FCM). * Requires dialysis for treatment of chronic kidney disease. * No evidence of iron deficiency. * Any non-viral infection. * AST or ALT at screen 1, 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. * Estimated life expectancy of less than 6 months or, for cancer patients, an ECOG Performance Status greater than 1. * 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 females who are of childbearing potential and who are not willing to use an acceptable form of contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Increase From Baseline to the Highest Observed Hemoglobin Value Between Baseline and Day 35 or Time of Intervention for Patients Taking FCM as Compared to That for Patients Taking Ferrous Sulfate. | Day 35 |
Countries
United States
Participant flow
Recruitment details
Hospitals and Medical Clinics
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 (Group A) - Ferric Carboxymaltose (FCM) Intravenous (IV) iron
Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7. | 246 |
| Cohort 1 (Group B) - Ferrous Sulfate Oral iron
Ferrous Sulfate Tablets : 325 mg Ferrous Sulfate tablets taken orally three times a day | 253 |
| Cohort 2 (Group C) - Ferric Carboxymaltose (FCM) Intravenous (IV) iron
Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7. | 253 |
| Cohort 2 (Group D) - IV Iron (Standard of Care) Other IV iron IV Iron (standard of care) : IV standard of care (other IV iron) per the Investigator's discretion | 245 |
| Total | 997 |
Baseline characteristics
| Characteristic | Cohort 1 (Group B) - Ferrous Sulfate | Cohort 2 (Group C) - Ferric Carboxymaltose (FCM) | Cohort 1 (Group A) - Ferric Carboxymaltose (FCM) | Cohort 2 (Group D) - IV Iron (Standard of Care) | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 7 Participants | 2 Participants | 2 Participants | 3 Participants | 14 Participants |
| Age, Categorical >=65 years | 38 Participants | 35 Participants | 35 Participants | 24 Participants | 132 Participants |
| Age, Categorical Between 18 and 65 years | 208 Participants | 216 Participants | 209 Participants | 218 Participants | 851 Participants |
| Age, Continuous | 43.5 years STANDARD_DEVIATION 17.71 | 43.6 years STANDARD_DEVIATION 16.88 | 43.1 years STANDARD_DEVIATION 17.18 | 42.6 years STANDARD_DEVIATION 15.51 | 43.2 years STANDARD_DEVIATION 16.63 |
| Region of Enrollment United States | 253 participants | 253 participants | 246 participants | 245 participants | 997 participants |
| Sex: Female, Male Female | 238 Participants | 239 Participants | 233 Participants | 231 Participants | 941 Participants |
| Sex: Female, Male Male | 15 Participants | 14 Participants | 13 Participants | 14 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 31 / 246 | 5 / 253 | 26 / 253 | 10 / 245 |
| serious Total, serious adverse events | 8 / 246 | 10 / 253 | 17 / 253 | 16 / 245 |
Outcome results
Primary
Mean Increase From Baseline to the Highest Observed Hemoglobin Value Between Baseline and Day 35 or Time of Intervention for Patients Taking FCM as Compared to That for Patients Taking Ferrous Sulfate.
Time frame: Day 35
Population: Modified Intent-to-Treat Population: Subjects who have received at least 1 dose of randomized study medication and had at least 1 post-baseline hemoglobin assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (Group A) - Ferric Carboxymaltose (FCM) | Mean Increase From Baseline to the Highest Observed Hemoglobin Value Between Baseline and Day 35 or Time of Intervention for Patients Taking FCM as Compared to That for Patients Taking Ferrous Sulfate. | 1.57 g/dL | Standard Deviation 1.194 |
| Cohort 1 (Group B) - Ferrous Sulfate | Mean Increase From Baseline to the Highest Observed Hemoglobin Value Between Baseline and Day 35 or Time of Intervention for Patients Taking FCM as Compared to That for Patients Taking Ferrous Sulfate. | 0.80 g/dL | Standard Deviation 0.799 |
| Cohort 2 (Group C) - Ferric Carboxymaltose (FCM) | Mean Increase From Baseline to the Highest Observed Hemoglobin Value Between Baseline and Day 35 or Time of Intervention for Patients Taking FCM as Compared to That for Patients Taking Ferrous Sulfate. | 2.90 g/dL | Standard Deviation 1.64 |
| Cohort 2 (Group D) - IV Iron (Standard of Care) | Mean Increase From Baseline to the Highest Observed Hemoglobin Value Between Baseline and Day 35 or Time of Intervention for Patients Taking FCM as Compared to That for Patients Taking Ferrous Sulfate. | 2.16 g/dL | Standard Deviation 1.252 |