2 Doses of Ferrlecit Versus Oral Iron to Treat Iron-deficiency Anemia in Peritoneal Dialysis Patients.

Study Overview
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Brief Summary
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This is a phase 3 clinical investigation. Patients who meet the eligibility criteria and provide signed informed consent will be randomized to receive one of two levels of Ferrlecit or oral iron in a 1:1:1 ratio.

Official Title
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A Multi-center, Randomized, Open Label Study of the Efficacy and Safety of Two Doses of Ferrlecit Versus Oral Iron to Treat Iron-deficiency Anemia in Peroneal Dialysis Patients Receiving Erythropoietin.

Conditions
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Iron Deficiency Anemia

Intervention / Treatment
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* Drug: Sodium Ferric Gluconate Complex
* Drug: Sodium Ferric Gluconate Complex
* Drug: Oral Iron


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, at least 18 years of age. Received maintenance peritoneal dialysis therapy for at least 4 weeks. Was expected to remain on peritoneal dialysis therapy for duration of study. Had predetermined low hemoglobin and transferrin saturation (TSAT) levels. Signed patient informed consent. Exclusion Criteria: Had a predetermined serum levels of Ferritin and TSAT Pregnant or lactating. Had a serious concomitant medical disorder incompatible with participation in the study. Had a known hypersensitivity to Ferrlecit or any of its components. Unable to cooperate or comply with the protocol.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sodium ferric gluconate complex 125 mg<br>125 mg sodium ferric gluconate weekly x 8 weeks | Drug: Sodium Ferric Gluconate Complex<br>* 125 mg weekly x 8 weeks<br>* Other names: Ferrlecit;|
| Experimental: Sodium ferric gluconate complex 250 mg<br>250 mg sodium ferric gluconate complex weekly x 4 weeks | Drug: Sodium Ferric Gluconate Complex<br>* 250 mg weekly x 4<br>* Other names: Ferrlecit;|
| Active Comparator: Oral iron<br>325 mg ferrous sulfate three times daily x 8 weeks | Drug: Oral Iron<br>* 325 mg ferrous sulfate orally three times daily x 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin | Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection | Baseline to 5 weeks and 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Hematocrit (Hct) | Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection | Baseline to 5 weeks and 9 weeks | 
| Change From Baseline in Transferrin Saturation (TSAT). | Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection | Baseline to 5 weeks and 9 weeks | 
| Change From Baseline in Serum Ferritin. | Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection | Baseline to 5 weeks and 9 weeks | 
| Responders by Treatment Group | Patients were classified as responders to treatment if they had an increase in Hgb of at least 1.0 g/dL assessed at 2 weeks following the final administration of Ferrlecit or 1 week following the last dose of oral iron. | Baseline to 5 weeks and 9 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anemia.