Kidney Transplantation
Conditions
Brief summary
This study evaluated renal graft function based on calculated creatinine clearance at 6 months after transplantation in patients receiving a regimen of 'reduced' or 'standard' dose tacrolimus plus sirolimus and corticosteroids.
Detailed description
This study evaluated renal graft function based on calculated creatinine clearance at 6 months after transplantation in patients receiving a regimen of 'reduced' or 'standard' dose tacrolimus plus sirolimus and corticosteroids. Blood serum creatinine, the incidence of biopsy-confirmed acute graft rejection, and patient and graft survival were also evaluated at 6 months post transplantation.
Interventions
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 donor * Patients with secondary kidney transplant must have maintained their primary graft for at least 6 months
Exclusion criteria
* Planned antibody induction * Multiple organ transplants * Patients at high risk of acute rejection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Graft function as measured by calculated creatinine clearance at month 6 post-transplantation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood serum creatinine, incidence of biopsy-confirmed acute graft rejection, and patient and graft survival at 6 months; presumptive acute rejection; incidence of infection; histologically-confirmed lymphoproliferative disease or malignancy. | — |
Outcome results
None listed