Renal Transplantation
Conditions
Keywords
Renal allograft, Renal, Kidney, Transplant
Brief summary
To assess equivalence in the rates of functional graft survival at 12 months after transplantation in patients receiving continuous therapy with cyclosporine (CsA, Sandimmune, Neoral) and sirolimus versus induction with CsA and sirolimus followed by CsA elimination and concentration-controlled sirolimus.
Interventions
DRUGSirolimus
DRUGcyclosporine
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* End-stage renal disease, with patients receiving a primary or secondary renal allograft from a cadaveric donor, from a living-unrelated donor, or from a living-related (excluding 0 antigen mismatch) donor. * Women who are of childbearing potential must have a negative pregnancy test before sirolimus administration and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of sirolimus
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. * Chronic antiarrhythmic therapy for ventricular arrhythmia or other cardiac abnormality contraindicating general anesthesia or surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Equivalence of graft survival at month 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Renal function; biopsy-confirmed acute rejection, grade of acute rejection; subject and graft survival; incidence of infection, malignancy, treatment failure, and of chronic rejection as determined by protocol biopsies; quality of life. | — |
Outcome results
None listed