Anemia
Conditions
Keywords
Anemia, Chronic Kidney Disease, Iron
Brief summary
This study compares the efficacy and safety of intravenous (IV) iron (VIT45) versus oral iron (ferrous sulfate) administered to subjects who suffer from anemia and are diagnosed with non-dialysis dependent chronic kidney disease (NDD-CKD).
Detailed description
This study compares the efficacy and safety of intravenous (IV) iron (VIT45) versus oral iron (ferrous sulfate) administered to subjects who suffer from anemia and are diagnosed with non-dialysis dependent chronic kidney disease (NDD-CKD).
Interventions
325 mg/TID x 8 weeks
A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values.
Sponsors
American Regent, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males or females \> or = 12 years of age * NDD-CKD subjects * Baseline hemoglobin \< or = 11g/dl * Stable erythropoietin (EPO) status
Exclusion criteria
* Known hypersensitivity to ferrous sulfate or IV iron * Unstable EPO status * Anemia not related to CKD * Chronic, serious infection * Recent IV iron * Recent blood transfusion * Recent blood loss * Need for surgery * Received investigational drug within 30 days * Female subjects who are pregnant or lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Subjects Achieving an Increase in Hemoglobin ≥1g/dL | anytime during the study |
Countries
United States
Participant flow
Recruitment details
Hospitals and medical clinics
Participants by arm
| Arm | Count |
|---|---|
| Ferric Carboxymaltose (FCM) A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values. | 147 |
| Ferrous Sulfate Tablets 325 mg/TID x 8 weeks | 103 |
| Total | 250 |
Baseline characteristics
| Characteristic | Ferrous Sulfate Tablets | Ferric Carboxymaltose (FCM) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 61 Participants | 82 Participants | 143 Participants |
| Age, Categorical Between 18 and 65 years | 42 Participants | 65 Participants | 107 Participants |
| Age, Continuous | 66.8 years STANDARD_DEVIATION 13.48 | 65.4 years STANDARD_DEVIATION 12.56 | 65.94 years STANDARD_DEVIATION 12.94 |
| Region of Enrollment United States | 103 participants | 147 participants | 250 participants |
| Sex: Female, Male Female | 73 Participants | 94 Participants | 167 Participants |
| Sex: Female, Male Male | 30 Participants | 53 Participants | 83 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 147 | 20 / 103 |
| serious Total, serious adverse events | 13 / 147 | 10 / 103 |
Outcome results
Primary
Number of Subjects Achieving an Increase in Hemoglobin ≥1g/dL
Time frame: anytime during the study
Population: Modified Intent to Treat (mITT) population defined as subjects who received at least 1 dose of study medication, had stable EPO for at least 8 weeks prior to randomization, had at least 1 post-baseline hemoglobin assessment, and who had NDD-CKD characterized by a GFR ≤45 mL/min/1.73²
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ferric Carboxymaltose (FCM) | Number of Subjects Achieving an Increase in Hemoglobin ≥1g/dL | 87 participants |
| Ferrous Sulfate Tablets | Number of Subjects Achieving an Increase in Hemoglobin ≥1g/dL | 35 participants |