Renal Transplantation
Conditions
Keywords
Renal/Kidney, transplantation, everolimus, calcineurin sparing
Brief summary
This study will assess the safety and efficacy of everolimus with basiliximab, corticosteroids and lower levels versus higher levels of tacrolimus in de novo renal transplant recipients.
Interventions
DRUGEverolimus
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Inclusion criteria
* Male or female patients between 18 and 65 years of age * Male or female patients who are primary cadaveric, living unrelated or non-HLA identical living related donor renal transplant recipients * The renal cold ischemic time (CIT) must be \< 30 hours * The age of the donor must be between 10 and 59 years and not meet UNOS expanded donor criteria
Exclusion criteria
* Patients meeting any of the following criteria at baseline will be excluded from study participation. * Patients who have previously received an organ transplant * Patients who are recipients of a multiple organ transplants * Recipients of non heart-beating donor organs Other protocol define inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| renal function as measured by serum creatinine at 6 months post-transplant | — |
Secondary
| Measure | Time frame |
|---|---|
| Renal function as measured by calculated creatinine clearance and calculated glomerular filtration rate at 6 months | — |
| Occurrence of biopsy-proven acute rejection at 6 months post-transplant | — |
| Combined and individual incidence of biopsy-proven acute rejection episodes, graft loss, and death at 6 months | — |
| Incidence of adverse events and serious adverse events | — |
| Incidence of New Onset Diabetes post-transplant at 3 and 6 months | — |
Outcome results
None listed