Anemia, Iron-Deficiency, Kidney Failure, Chronic
Conditions
Keywords
Iron deficiency, Anemia, Chronic kidney disease, Erythropoietic agents, Sodium Ferric Gluconate, Anemia, Iron-Deficiency/drug therapy/etiology, Kidney Failure, Chronic/blood/complications/therapy, Erythropoietin, Recombinant/adverse effects/therapeutic use
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 receiving erythropoietic agents, such as Procrit® and Aranesp®.
Interventions
Sodium ferric gluconate complex in sucrose, 250 mg IV weekly for 4 doses
ferrous sulfate 325 mg 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 * Receiving therapy with erythropoietic agent
Exclusion criteria
* Receiving dialysis * Known sensitivity to Ferrlecit® or any of its components * Clinically unstable
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Baseline Hemoglobin Concentration | Baseline | — |
| 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 |
|---|---|---|
| Baseline Serum Ferritin Concentration | Baseline | — |
| 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 |
|---|---|
| Ferrlecit Sodium ferric gluconate complex in sucrose injection | 26 |
| Oral Iron | 26 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | Did not meet lab incusion criteria | 2 | 3 |
| Overall Study | Other | 2 | 0 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | Oral Iron | Ferrlecit | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 18 Participants | 14 Participants | 32 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 12 Participants | 20 Participants |
| Age Continuous | 66.1 years STANDARD_DEVIATION 14.65 | 67.4 years STANDARD_DEVIATION 17.75 | 66.8 years STANDARD_DEVIATION 16.13 |
| Region of Enrollment United States | 26 participants | 26 participants | 52 participants |
| Sex: Female, Male Female | 16 Participants | 12 Participants | 28 Participants |
| Sex: Female, Male Male | 10 Participants | 14 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 18 / 26 | 16 / 26 |
| serious Total, serious adverse events | 4 / 26 | 2 / 26 |
Outcome results
Primary
Baseline Hemoglobin Concentration
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ferrlecit | Baseline Hemoglobin Concentration | 10.3 g/dL | Standard Deviation 0.9 |
| Oral Iron | Baseline Hemoglobin Concentration | 10.4 g/dL | Standard Deviation 0.92 |
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 |
|---|---|---|---|
| Ferrlecit | Change in Hemoglobin (Hgb) | 1.2 g/dL | Standard Deviation 1.23 |
| Oral Iron | Change in Hemoglobin (Hgb) | 1.0 g/dL | Standard Deviation 1.34 |
Secondary
Baseline Serum Ferritin Concentration
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ferrlecit | Baseline Serum Ferritin Concentration | 74.3 ng/mL | Standard Deviation 80.95 |
| Oral Iron | Baseline Serum Ferritin Concentration | 68.7 ng/mL | Standard Deviation 67.36 |
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 |
|---|---|---|---|
| Ferrlecit | Change in Serum Ferritin | 150.0 ng/mL | Standard Deviation 113.11 |
| Oral Iron | Change in Serum Ferritin | 18.1 ng/mL | Standard Deviation 33.66 |