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
About this trial
This is an interventional prevention trial for Anemia focused on measuring Anemia, epoetin alfa
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
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
NCT ID
NCT00364260
First Posted
August 11, 2006
Last Updated
January 31, 2011
Sponsor
Janssen-Ortho Inc., Canada
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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