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A Safety and Efficacy Study for Epoetin Alfa in Pre-dialysis Subjects.

Primary Purpose

Anemia, Kidney Failure, Left Ventricular Hypertrophy

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
epoetin alfa
Sponsored by
Janssen-Ortho Inc., Canada
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anemia focused on measuring Anemia, epoetin alfa

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients have had a decrease in hemoglobin >= 10 g/L within the past 12 months and a current hemoglobin level between 110-135 g/L (men) and 100-135 g/L (women) OR a hemoglobin level between 115-125 g/L (men) and 110-120 g/L (women) Have a calculated creatinine clearance <80 mL/min and >15 mL/min Exclusion Criteria: No uncontrolled hypertension (diastolic blood pressure>= 105 mm Hg on average for the previous month) No unstable angina or cardiac procedure within the past 12 months or a planned procedure No myocardial infarction with the past 12 months

Sites / Locations

    Outcomes

    Primary Outcome Measures

    The change in left ventricular mass index from baseline to 24 months as measured by 2-dimensional targeted M-mode echocardiography.

    Secondary Outcome Measures

    The difference in renal function (calculated creatinine clearance) between groups at 24 months; The functional cardiac status (NYHA/CCS classification) between groups at 24 months;The change in SF-36 scores between groups from baseline to 24 months

    Full Information

    First Posted
    August 11, 2006
    Last Updated
    January 31, 2011
    Sponsor
    Janssen-Ortho Inc., Canada
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00364260
    Brief Title
    A Safety and Efficacy Study for Epoetin Alfa in Pre-dialysis Subjects.
    Official Title
    A Study to Determine the Impact of Hemoglobin Maintenance and Other Interventional Strategies to Prevent or Delay the Progression of Left Ventricular Mass Growth in Subjects With Early Renal Insufficiency.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    December 1997 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    August 2003 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Janssen-Ortho Inc., Canada

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to determine if using Eprex, to maintain hemoglobin within the normal range, will prevent or delay the progression of left ventricular mass growth.
    Detailed Description
    Cardiovascular disease continues to be the major cause of morbidity and mortality in subjects with renal (kidney) disease. Left ventricular hypertrophy (LVH) has been correlated with a high risk of cardiac and all cause mortality. In the renal population , many factors have been shown to be important in the development of LVH, including anemia. This is a multicentre, open, controlled, randomized trial to determine if maintaining hemoglobin within the normal range delays the progress of left ventricular mass growth. Additionally, this study will evaluated the safety of maintaining hemoglobin within the normal range in pre-dialysis subjects. The trial duration is 24 months. Subjects randomized to the treatment arm will receive Eprex therapy to maintain hemoglobin between 120-140 g/L. Subjects randomized to the control arm will not receive any treatment unless their hemoglobin falls to less than or equal to 90 g/L. Those subjects will then be treated to maintain their hemoglobin between 90-105 g/L. The subjects were to receive injections of Eprex once weekly to maintain hemoglobin levels within the target range for the arm to which they were randomized. The subjects were to receive treatment for up to 24 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anemia, Kidney Failure, Left Ventricular Hypertrophy
    Keywords
    Anemia, epoetin alfa

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    172 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    epoetin alfa
    Primary Outcome Measure Information:
    Title
    The change in left ventricular mass index from baseline to 24 months as measured by 2-dimensional targeted M-mode echocardiography.
    Secondary Outcome Measure Information:
    Title
    The difference in renal function (calculated creatinine clearance) between groups at 24 months; The functional cardiac status (NYHA/CCS classification) between groups at 24 months;The change in SF-36 scores between groups from baseline to 24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients have had a decrease in hemoglobin >= 10 g/L within the past 12 months and a current hemoglobin level between 110-135 g/L (men) and 100-135 g/L (women) OR a hemoglobin level between 115-125 g/L (men) and 110-120 g/L (women) Have a calculated creatinine clearance <80 mL/min and >15 mL/min Exclusion Criteria: No uncontrolled hypertension (diastolic blood pressure>= 105 mm Hg on average for the previous month) No unstable angina or cardiac procedure within the past 12 months or a planned procedure No myocardial infarction with the past 12 months
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Janssen-Ortho Inc. Clinical Trial
    Organizational Affiliation
    Janssen-Ortho Inc., Canada
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16253719
    Citation
    Levin A, Djurdjev O, Thompson C, Barrett B, Ethier J, Carlisle E, Barre P, Magner P, Muirhead N, Tobe S, Tam P, Wadgymar JA, Kappel J, Holland D, Pichette V, Shoker A, Soltys G, Verrelli M, Singer J. Canadian randomized trial of hemoglobin maintenance to prevent or delay left ventricular mass growth in patients with CKD. Am J Kidney Dis. 2005 Nov;46(5):799-811. doi: 10.1053/j.ajkd.2005.08.007.
    Results Reference
    result

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    A Safety and Efficacy Study for Epoetin Alfa in Pre-dialysis Subjects.

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