Anemia
Conditions
Keywords
Anemia
Brief summary
A phase 4 clinical investigation in iron-replete pediatric hemodialysis patients, whose legal guardian had provided signed informed consent, and who had satisfied the inclusion and exclusion criteria of the study.
Interventions
DRUGSodium Ferric Gluconate Complex in Sucrose.
Sponsors
Watson Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* Male or female pediatric ESRD, Patients \>\_ 2 and \<\_ 16 years of age, whose legally authorized representative provided signed informed consent. * Stabilized on chronic hemodialysis therapy with an identified need for maintenance iron therapy. * Predetermined TSAT and serum Ferritin (at the screening visit). * Receiving a stable EPO dosing regimen.
Exclusion criteria
* Receipt of any form of iron supplementation during the 2 weeks prior to the first Ferrlecit dosing. * Hypersensitivity to Ferrlecit or any of its inactive components. * High TSAT level. * High Serum Ferritin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Ferritin | 14 weeks | Change from baseline to 2 weeks after last Fe dose |
| Transferrin Saturation | 14 weeks | Change from baseline to 2 weeks after last dose |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the Effect of Intravenous Administration of Ferrlecit on Hematology Parameteres, on EPO Dose, and Safety. | 14 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sodium Ferric Gluconate Complex | 23 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Protocol Violation | 2 |
| Overall Study | unk | 3 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Sodium Ferric Gluconate Complex |
|---|---|
| Age, Categorical <=18 years | 23 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age Continuous | 13.2 years STANDARD_DEVIATION 2.39 |
| Region of Enrollment United States | 23 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 16 Participants |
Outcome results
Primary
Serum Ferritin
Change from baseline to 2 weeks after last Fe dose
Time frame: 14 weeks
Population: Per protocol (completer) population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sodium Ferric Gluconate Complex | Serum Ferritin | 26.7 ng/mL | Standard Deviation 240.05 |
Primary
Transferrin Saturation
Change from baseline to 2 weeks after last dose
Time frame: 14 weeks
Population: Per protocol (completer) population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sodium Ferric Gluconate Complex | Transferrin Saturation | 2.0 % | Standard Deviation 11.67 |
Secondary
Evaluate the Effect of Intravenous Administration of Ferrlecit on Hematology Parameteres, on EPO Dose, and Safety.
Time frame: 14 weeks