Kidney Transplantation
Conditions
Brief summary
The study evaluated renal graft function (based on the calculated creatinine clearance) 6 months after kidney transplantation in patients receiving either a regimen of 'reduced-dose' tacrolimus + sirolimus + corticosteroids or a regimen of 'standard-dose' tacrolimus + sirolimus + corticosteroids.
Detailed description
The study evaluated renal graft function (based on the calculated creatinine clearance) 6 months after kidney transplantation in patients receiving either a regimen of 'reduced-dose' tacrolimus + sirolimus + corticosteroids or a regimen of 'standard-dose' tacrolimus + sirolimus + corticosteroids. The two treatment groups were also compared with respect to the incidence of acute graft rejection at 6 months and patient and graft survival at 6 months after transplantation.
Interventions
DRUGTacrolimus
DRUGPerioperative Corticosteroids
The corticosteroids use was left up to the investigators decision.
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 No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years of age * End-stage renal disease in patients receiving a primary or secondary renal allograft from a cadaveric, living-unrelated, or living-related mismatched donor * Patients with a secondary transplant must have maintained a primary graft for at least 6 months
Exclusion criteria
* Planned antibody induction * Multiple organ transplants * History of malignancy within five years of enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Calculated creatinine clearance at month 6 post transplantation | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Patient and graft survival at 6 months post transplantation; the safety of sirolimus + corticosteroids given concomitantly with reduced or standard dose tacrolimus | 6 months |
Outcome results
None listed