Status:
COMPLETED
A Safety and Efficacy Study for Epoetin Alfa in Pre-dialysis Subjects.
Lead Sponsor:
Janssen-Ortho Inc., Canada
Conditions:
Anemia
Kidney Failure
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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 ca...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2003
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT00364260
Start Date
December 1 1997
End Date
August 1 2003
Last Update
February 1 2011
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