Efficacy and Safety of Venofer (Iron Sucrose Injection USP) in Patients Receiving Peritoneal Dialysis

Study Overview
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Brief Summary
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This is a open-label, prospective study comparing intravenous (IV) iron supplementation to standard care in anemic patents undergoing peritoneal dialysis.

Detailed Description
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This is an open-label, prospective study comparing IV iron supplementation to standard care in anemic patients undergoing peritoneal dialysis. After successfully completing a 6 month enrollment period, qualifying patients were randomized to receive 1000mg of IV iron over a four week period, or no iron supplementation. Erythropoietin regimen was to remain stable. Patients were followed to day 71 for safety and efficacy.

Official Title
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Efficacy and Safety of Venofer (Iron Sucrose Injection USP) in Patients Receiving Peritoneal Dialysis

Conditions
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Anemia

Intervention / Treatment
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* Drug: Venofer and stable erythropoietin (EPO) regimen
* Drug: stable erythropoietin (EPO) regimen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hemoglobin >= 9.5 and <= 11.5 g/dL. Ferritin <= 500 ng/ml. Serum Transferrin Saturation (TSAT) <= 25%. Stable erythropoietin (EPO) Regimen for 8 weeks. No iron for last 4 weeks before randomization. Exclusion Criteria: Known Sensitivity to Iron Sucrose. Suffering concomitant severe diseases of the liver & cardiovascular system. Pregnancy / Lactation. Inadequate dialysis. Current treatment for asthma. Significant blood loss. Probability of need for transfusion or transfusion within 1 week of enrollment. Anticipated major surgery. Hemochromatosis / hemosiderosis.

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: Group A<br>Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29. | Drug: Venofer and stable erythropoietin (EPO) regimen<br>* Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.<br>* Other names: Iron Sucrose;|
| Active Comparator: Group B<br>Stable erythropoietin (EPO) dose and no supplemental iron. | Drug: stable erythropoietin (EPO) regimen<br>* Stable erythropoietin (EPO) dose and no supplemental iron.<br>* Other names: EPO;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline to the Highest Hemoglobin up to Day 71 |  | Change from Baseline up to Day 71 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Mean Change From Baseline to the Highest Serum Transferrin Saturation (TSAT) up to Day 71 |  | Change from Baseline up to Day 71 | 
| The Mean Change From Baseline to the Highest Ferritin up to Day 71 |  | Change from Baseline up to Day 71 | 
| The Mean Change From Baseline to the Highest Reticulocyte Count up to Day 71 |  | Change from Baseline up to Day 71 | 

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