A Study to Assess Use of Zenapax (Daclizumab) and CellCept (Mycophenolate Mofetil) to Improve Kidney Function in Kidney Transplant Patients
Phase 3
Completed
- Conditions
- Kidney Transplantation
- Interventions
- Registration Number
- NCT00048152
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 539
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Corticosteroids - 1 Neoral - 1 Zenapax - 1 mycophenolate mofetil [CellCept] - 2 Corticosteroids - 2 Neoral - 2 Zenapax - 2 mycophenolate mofetil [CellCept] - 3 Corticosteroids - 3 Neoral - 3 mycophenolate mofetil [CellCept] -
- Primary Outcome Measures
Name Time Method Renal function (as measured by GFR) 12 months post-transplant
- Secondary Outcome Measures
Name Time Method 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