A Study of the Safety and Efficacy of Long-term Correction of Anemia With Epoetin Alfa in Early Hemodialysis Patients

• Status: Completed
• Trial end date: 2003-05-01
• Target enrollment: 0
• Participant gender: All

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 function.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.