A Safety and Efficacy Study for Epoetin Alfa in Pre-Dialysis Subjects.
Information source: Janssen-Ortho Inc., Canada
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Left Ventricular Hypertrophy; Anemia; Kidney Failure
Intervention: epoetin alfa (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Janssen-Ortho Inc., Canada Official(s) and/or principal investigator(s):
Janssen-Ortho Inc. Clinical Trial, Study Director, Affiliation: Janssen-Ortho Inc., Canada
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.
Clinical Details
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 design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The change in left ventricular mass index from baseline to 24 months as mesaured by 2-dimensional targeted M-mode echocardiography.
Secondary outcome: 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
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, contolled, randomized trial to determine if maintaining hemoglobin within
the normal range delays the progess of left venticular 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: October 1997
Ending date: August 2003
Last updated: May 18, 2007
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