EPO-BUL-01 - Study of the Optimization of Anemia Management of EPREX (Epoetin Alfa) in Predialysis Patients With Chronic Renal Failure

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the effectiveness, safety and clinical outcome of Epoetin alfa with dosing regime in accordance with Summary of Product Characteristics in the treatment of anemia in predialysis.

Detailed Description
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Open-label, non-randomized, multicenter study for anemic patients with hemoglobin <or=11 g/dl. The dose of epoetin alfa is the routine dosage regimen and is in accordance of the approved SmPC. That's why the study had in general two phases - first period: subcutaneous administration and second period:intravenous administration. The evaluation is made in 4 visits:baseline, 2 month (Visit 1), 4 month (Visit 2), 6 month (Visit 3), 9 month (Visit 4). Echographic evaluation - on baseline visit, Visit 3 and Visit 4.Baseline visit - weight, arterial pressure, Hemoglobin, Hematocrit, Erythrocytes, Middle Cells Volume, Middle Cells Hemoglobin, Middle Cells Hemoglobin Concentration, Transferrin, Creatinine, Clerans, Visit1, Visit 2, Visit 3, Visit 4 - Hemoglobin, Hematocrit, Erythrocytes, Middle Cells Volume, Middle Cells Hemoglobin, Middle Cells Hemoglobin Concentration. The dosage is in routine dosing regimen, the starting dose of epoetin alfa is 50 Units/kg body weight. The maintaining dose depends on hematological results. Administration - subcutaneous (during the first period), intravenous (second period). Duration of the study - 9 months.

Official Title
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An Open-Label Study of the Optimization of Anemia Management of EPREX (Epoetin Alfa) in Predialysis Patients With Chronic Renal Failure

Conditions
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Chronic Renal Failure

Intervention / Treatment
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* Drug: Epoetin alfa


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Hb<or= 11g/dl Females - using adequate contraceptive method Exclusion Criteria: Patients with uncontrolled or severe cardiovascular disease, including recent myocardial infarction, uncontrolled hypertension or congestive heart failure treatment within the previous 6 months with epoetin alfa or any erythropoietin, known hypersensitivity to the product or to any of the ingredients patient not in line with the approved SmPC

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Epoetin alfa|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin change - reach of target Hb levels (measured at Visit 1, 2, 3, 4) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of left ventricular hypertrophy (measured at Visit 3 and 4) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic renal failure, left ventricular hypertrophy, epoetin alfa