Graft Rejection, Kidney Failure, Kidney Transplantation
Conditions
Keywords
Kidney Transplant
Brief summary
Evaluate renal graft function (based on the calculated Glomerular Filtration Rate) at 12 months after transplantation in patients receiving either a regimen of sirolimus plus mycophenolate mofetil following an antibody induction (RATG) or a standard regimen combining tacrolimus plus mycophenolate mofetil, both regimens including corticosteroids in patients undergoing renal allograft transplantation. In addition, the two treatment groups will be compared with respect to the incidence of acute rejection at 3, 6 and 12 months following transplantation, and the patient and graft survival at 6 and 12 months after transplantation. The safety of sirolimus plus mycophenolate mofetil following an antibody induction (ATG) will be evaluated beginning in the immediate post-operative period.
Interventions
DRUGtacrolimus
DRUGmycophenolate mofetil
DRUGmethylprednisolone
DRUGprednisolone
DRUGsirolimus
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age: 18 and \< 65 years * End-stage renal disease, with patients scheduled to receive a primary renal allograft from a cadaveric donor * Patients receiving a second transplant without an immunological loss of their first graft in the first six months of transplant
Exclusion criteria
* Evidence of active systemic or localized major infection at the time of initial sirolimus administration * Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during pre-study screening * Use of any investigational drug or treatment up to 4 weeks prior to enrollment to the study and during the 12-month treatment phase
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| transplantation. | — |
| - Graft function as measured by Glomerular Filtration Rate (GFR) by Nankivell formula at Month 12 post- | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of occurrence of primary acute rejection biopsy confirmed by a local pathologist using the 1997 Banff | — |
| criteria at 3, 6 and 12 Months following transplantation | — |
| One year graft biopsy status | — |
| Incidence of document infection | — |
Outcome results
None listed