Status:
COMPLETED
A Study of the Safety and Efficacy of Long-term Correction of Anemia With Epoetin Alfa in Early Hemodialysis Patients
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Kidney Failure, Chronic
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study in early hemodialysis patients (on dialysis 3 to 18 months) is to assess the effect of correction versus partial correction of anemia using epoetin alfa on heart pumping func...
Detailed Description
Cardiovascular disease is very common among patients with end-stage renal disease. This study is a long-term, double-blind, parallel-group, multicenter study to determine the efficacy and safety of ad...
Eligibility Criteria
Inclusion
- On hemodialysis for 3 to 18 months and expected to remain on hemodialysis for at least two more years and with a life expectancy of a year or more
- Kidney transplant patients, whose transplant has failed, and now have been on hemodialysis for 3-18 months, may be eligible for the study, if they are not receiving excessive immunosuppression (e.g., \<=10 mg of steroids/day allowed)
- Pre-dialysis hemoglobin 8-12 g/dL, inclusive, within the previous month (single reading is sufficient)
- Stable hemodialysis vascular access, within the previous 3 months
- No heart disease or asymptomatic heart disease without enlarged heart
Exclusion
- Heart diseases for which surgical intervention occurred during the previous two years or which may require intervention within the next year
- Patients with medical conditions likely to affect the response to epoetin
- Predialysis sitting diastolic blood pressure \>= 100 mmHg on average for the previous month
- Folate, Vitamin B12, or transferrin deficiency
- History of seizure within 1 year
- Transfusion within 30 days prior to study entry.
Key Trial Info
Start Date :
February 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2003
Estimated Enrollment :
596 Patients enrolled
Trial Details
Trial ID
NCT00261521
Start Date
February 1 2000
End Date
May 1 2003
Last Update
December 3 2010
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