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

Primary Purpose

Chronic Renal Failure

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Epoetin alfa
Sponsored by
Janssen Pharmaceutica N.V., Belgium
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Renal Failure focused on measuring Chronic renal failure, left ventricular hypertrophy, epoetin alfa

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Hemoglobin change - reach of target Hb levels (measured at Visit 1, 2, 3, 4)

    Secondary Outcome Measures

    Prevention of left ventricular hypertrophy (measured at Visit 3 and 4)

    Full Information

    First Posted
    June 16, 2006
    Last Updated
    January 31, 2011
    Sponsor
    Janssen Pharmaceutica N.V., Belgium
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00338000
    Brief Title
    EPO-BUL-01 - Study of the Optimization of Anemia Management of EPREX (Epoetin Alfa) in Predialysis Patients With Chronic Renal Failure
    Official Title
    An Open-Label Study of the Optimization of Anemia Management of EPREX (Epoetin Alfa) in Predialysis Patients With Chronic Renal Failure
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2001 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    May 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Janssen Pharmaceutica N.V., Belgium

    4. Oversight

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Renal Failure
    Keywords
    Chronic renal failure, left ventricular hypertrophy, epoetin alfa

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    292 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Epoetin alfa
    Primary Outcome Measure Information:
    Title
    Hemoglobin change - reach of target Hb levels (measured at Visit 1, 2, 3, 4)
    Secondary Outcome Measure Information:
    Title
    Prevention of left ventricular hypertrophy (measured at Visit 3 and 4)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Janssen Pharmaceutica N.V. Clinical Trial
    Organizational Affiliation
    Janssen Pharmaceutica N.V.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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