Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients Receiving Erythropoietic Agents

Study Overview
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Brief Summary
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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®.

Official Title
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A Randomized, Controlled, Open-label Study of the Safety and Efficacy of Ferrlecit® vs Oral Iron in Iron Deficient Patients With Chronic Kidney Disease Being Treated With Erythropoietic Therapy

Conditions
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Anemia, Iron-Deficiency, Kidney Failure, Chronic

Intervention / Treatment
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* Drug: Sodium Ferric Gluconate complex in sucrose
* Drug: Ferrous sulfate tablets


Participation Criteria
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Eligibility Criteria
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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

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: IV iron<br> | Drug: Sodium Ferric Gluconate complex in sucrose<br>* Sodium ferric gluconate complex in sucrose, 250 mg IV weekly for 4 doses<br>* Other names: Ferrlecit;|
| Active Comparator: oral iron<br> | Drug: Ferrous sulfate tablets<br>* ferrous sulfate 325 mg three times daily for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline Hemoglobin Concentration |  | Baseline | 
| 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. | Baseline to 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline Serum Ferritin Concentration |  | Baseline | 
| 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. | Baseline to 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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