Comparison of Safety and Efficacy of Intravenous Iron Versus Oral Iron in Chronic Renal Failure Subjects With Anemia

Study Overview
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Brief Summary
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To assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in non-dialysis dependent, chronic renal failure in patients receiving or not receiving erythropoietin.

Detailed Description
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The intent of this study was to assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in non-dialysis dependent, chronic renal failure patients receiving or not receiving erythropoietin. After an extensive enrollment period, patients were randomized to receive oral iron (ferrous sulfate, 325mg three times daily (TID) for 56 days) or IV iron sucrose (total 1000mg, 500mg X 2 OR 200mg X 5 within two weeks). Erythropoietin schedule was to remain unchanged during the 56 day study.

Official Title
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Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in Chronic Renal Failure Subjects With Anemia

Conditions
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Anemia

Intervention / Treatment
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* Drug: Venofer
* Drug: Ferrous Sulfate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hemoglobin < or = 11.5 gm/dL Stable dose or not receiving EPO Renal Anemia Exclusion Criteria: IV iron with last 6 months Chronic infection, malignancy,major surgery within last month Blood Transfusion with last two months Significant blood loss within last 3 months Concomitant sever diseases of the liver

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: Venofer<br>iron sucrose injection | Drug: Venofer<br>* iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.<br>* Other names: iron sucrose tablets;|
| Active Comparator: Ferrous Sulfate<br>oral iron | Drug: Ferrous Sulfate<br>* oral iron tablets; 325 mg three times a day orally for 56 days<br>* Other names: Oral Iron Tablets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients With an Increase in Hemoglobin >= 1gm/dL. |  | Change from Baseline up to Day 56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With a Clinical Response | Clinical Response (change in Hemoblobin (Hgb) >= 1gm/dL and change in ferritin >= 160ng/ml) | Change from Baseline up to Day 56 | 
| Highest Change From Baseline in Hemoglobin (g/dL) up to Day 56 |  | Change from Baseline up to Day 56 | 
| Highest Change From Baseline in Ferritin (ng/mL) up to Day 56 |  | Change from Baseline up to Day 56 | 
| Mean Change in Ferritin (ng/mL) From Baseline to Day 56 |  | Change from Baseline at Day 56 | 
| Mean Change From Baseline in Serum Transferrin Saturation (TSAT) (%) at Day 56 |  | Change from Baseline at Day 56 | 
| Mean Change From Baseline in Hemoglobin (g/dL) at Day 56 |  | Change from Baseline at Day 56 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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iron, CKD, anemia