To clarify that tacrolimus-sparing regimen with minimal tacrolimus dose together with mycophenolate sodium dose increment will preserve renal allograft function without rising adverse effects Primary endpoints: 1. estimated GFR (MDRD equation) 12 months after randomization 2. estimated GFR change from randomization to end of the study (calculated by MDRD equation and Nankivell equation)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
350
oral regular dose of tacrolimus + less dose of myfortic trough level of tacrolimus will be 5-10 ng/mL and oral myfortic dose will be 180-360 mg twice a day
low dose of tacrolimus + maximum dose of myfortic target trough level of tacrolimus should be reduced to 2-5 ng/mL for 3 months after randomization and oral MPS dose increased to 540-720mg twice a day
Asan Medical Center
Seoul, Asan Medical Center, South Korea
estimated GFR (MDRD equation)12 months after randomization
Time frame: 12 months after randomization
Urine protein excretion
24hr urine collection or urine protein/creatinine ratio
Time frame: 12 months after randomization
graft survival
12 month graft survival
Time frame: 12 month after randomization
follow-up loss
frequency of follow-up loss
Time frame: From randomization to 12 months after randomization
Allograft biopsy
number of performed allograft biopsy performed
Time frame: From randomization to 12 months after randomization
Treated or biopsy proven acute rejection
Time frame: From randomization to 12 months after randomization
estimated GFR change from randomization to end of the study
calculated by MDRD equation and Nankivell equation
Time frame: 12 months after randomization
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