Kidney Disease
Conditions
Keywords
Kidney Disease
Brief summary
To assess equivalence in the rates of functional graft survival at 12 months after transplantation in patients receiving induction therapy with cyclosporin (CsA, Neoral) and Rapamune® followed by CsA dose reduction and concentration-controlled Rapamune® versus induction with CsA and Rapamune® followed by discontinuation of CsA and concentration-controlled Rapamune®.
Interventions
DRUGRapamune®
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
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age: = to ≥ 18 years. * End-stage renal disease, with patients scheduled to receive a primary or secondary renal allograft from a cadaveric donor, from a living-unrelated donor, or from a living-related donor. * Patients with second and subsequent transplants must have maintained their primary graft for at least 6 months after transplantation (with the exception of graft failure due to technical reasons).
Exclusion criteria
* Evidence of active systemic or localised major infection prior to initial Rapamune® administration. * Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during screening. * Use of any investigational drug or treatment up to 4 weeks prior to enrolling in the study and during the 12-month treatment phase. Exception: the use of erythropoiesis stimulating products. In these cases, erythrocyte-stimulating products must be discontinued prior to administration of Rapamune®.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Kidney Function at 12 months after transplantation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Kidney function at 6 months; incidence of side effects and rejection at 6 and 12 months. | — |
Outcome results
None listed