A Randomized, Open-label Study Comparing the Effects of Low-dose Cyclosporine vs Cyclosporine Withdrawal on Renal Function in Kidney Transplant Patients Treated With CellCept and Daclizumab
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 539
- Primary Endpoint
- Renal function (as measured by GFR)
Study Overview
Brief Summary
This study will compare kidney function in kidney transplant patients following treatment with various combinations of Zenapax, CellCept, corticosteroids, and Neoral (Cyclosporine). The anticipated time on study treatment is 6-12 months, and the target sample size is 500+ individuals.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •adult patients greater than 18 years of age
- •recipients of primary kidney transplant
- •single-organ recipients (kidney only)
Exclusion Criteria
- •previous treatment with Zenapax
- •history of malignancy (except localized skin cancer)
Arms & Interventions
1
Intervention: Corticosteroids (Drug)
1
Intervention: Neoral (Drug)
1
Intervention: Zenapax (Drug)
1
Intervention: mycophenolate mofetil [CellCept] (Drug)
2
Intervention: Corticosteroids (Drug)
2
Intervention: Neoral (Drug)
2
Intervention: Zenapax (Drug)
2
Intervention: mycophenolate mofetil [CellCept] (Drug)
3
Intervention: Corticosteroids (Drug)
3
Intervention: Neoral (Drug)
3
Intervention: mycophenolate mofetil [CellCept] (Drug)
Outcomes
Primary Outcomes
Renal function (as measured by GFR)
Time Frame: 12 months post-transplant
Secondary Outcomes
- AEs, OIs, malignancies, deaths(Throughout study)
- Patient and graft survival \n(12 months post-transplant)
- Proportion of patients with biopsy-proven rejection; treatment failure.(6 and 12 months post-transplant)