This study was done to find out which treatment, tacrolimus or sirolimus, leads to better long-term kidney function in kidney transplant patients.
The aim of this study was to compare the complete avoidance of calcineurin inhibitors (CI) using a sirolimus-based immunosuppressive regimen to a tacrolimus-based regimen in kidney transplantation. This study was a prospective open-label trial randomizing patients to receive tacrolimus, mycophenolate mofetil and prednisone or sirolimus, mycophenolate mofetil and prednisone. All patients received antithymocyte globulin induction. All rejection episodes were proven by biopsy. The hypothesis was that CI free immunosuppression after kidney transplantation will lead to an increase in glomerular filtration rate (GFR) at one year after kidney transplantation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
165
Thymoglobulin 1.5 mg/kg/d (days 0,1,2,4,6)
Mycophenolate mofetil 750 mg p.o. b.i.d.- maintenance
Prednisone 500 mg/day initially, tapered to 5 mg/day by day 92
Mayo Clinic
Rochester, Minnesota, United States
Glomerular filtration rate (GFR) (iothalamate clearance) at 12 months following transplantation
Glomerular filtration rate (Iothalamate clearance) at 12 months following transplantation.
Time frame: 12 months following transplantation
GFR (iothalamate clearance) at other time points
Time frame: 24 months
Other measures of renal function (serum creatinine, proteinuria and albuminuria)
Time frame: 24 months
Acute rejection both early and after tacrolimus withdrawal
Time frame: 24 months
Patient and graft survival
Time frame: 24 months after transplantation
Complications-especially hypertension, diabetes, dyslipidemia
Time frame: 24 months
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Tacrolimus - maintain trough levels of 6-8 ng/ml (whole blood Imx assay)
Rapamycin 3 to 5 mg/day; adjust to the high-performance liquid chromatography (HPLC) blood level 15 to 20 ng ml