Anemia, Iron-Deficiency, Kidney Failure, Chronic
Conditions
Keywords
Iron deficiency, Anemia, Chronic kidney disease, Sodium Ferric Gluconate, Anemia, Iron-Deficiency/drug therapy/etiology, Kidney Failure, Chronic/blood/complications/therapy
Brief summary
This study compares the effect of Ferrlecit® (a form of intravenous iron) to ferrous sulfate (a form of oral iron) in treating anemia and iron deficiency in chronic kidney disease patients who are not receiving erythropoietic agents (hormones that stimulate the bone marrow to make more red blood cells).
Interventions
Sodium Ferric Gluconate Complex in Sucrose Injection (Ferrlecit®), 250 mg IV weekly for 4 weeks
ferrous sulfate, 325 mg oral, three times daily for 6 weeks
Sponsors
Watson Pharmaceuticals
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
* Moderate to severe anemia * Iron deficiency * Moderate to severe chronic kidney disease
Exclusion criteria
* Receiving dialysis * Known sensitivity to Ferrlecit® or any of its components * Receiving therapy with erythropoietic agent * Clinically unstable
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin (Hgb) | Baseline to 10 weeks | Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Serum Ferritin | Baseline to 10 weeks | Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d. |
Countries
Puerto Rico, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IV Iron | 44 |
| Oral Iron | 45 |
| Total | 89 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 9 | 3 |
| Overall Study | Inclusion Violation | 3 | 6 |
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | Other | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | IV Iron | Oral Iron | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 15 Participants | 26 Participants | 41 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants | 19 Participants | 48 Participants |
| Age Continuous | 66.3 years STANDARD_DEVIATION 12.27 | 62.6 years STANDARD_DEVIATION 14.86 | 64.4 years STANDARD_DEVIATION 13.7 |
| Region of Enrollment Puerto Rico | 1 participants | 1 participants | 2 participants |
| Region of Enrollment United States | 43 participants | 44 participants | 87 participants |
| Sex: Female, Male Female | 24 Participants | 25 Participants | 49 Participants |
| Sex: Female, Male Male | 20 Participants | 20 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 22 / 44 | 21 / 45 |
| serious Total, serious adverse events | 4 / 44 | 4 / 45 |
Outcome results
Primary
Change in Hemoglobin (Hgb)
Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d.
Time frame: Baseline to 10 weeks
Population: Modified ITT with LOCF imputation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IV Iron | Change in Hemoglobin (Hgb) | 0.6 g/dL | Standard Deviation 0.94 |
| Oral Iron | Change in Hemoglobin (Hgb) | 0.2 g/dL | Standard Deviation 1.11 |
Secondary
Change in Serum Ferritin
Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d.
Time frame: Baseline to 10 weeks
Population: Modified ITT with LOCF imputation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IV Iron | Change in Serum Ferritin | 207.7 ng/mL | Standard Deviation 207.02 |
| Oral Iron | Change in Serum Ferritin | 22.6 ng/mL | Standard Deviation 53.4 |