Primary purpose of this study is to compare renal function between subjects receiving optimized dose Advagraf® over 52 weeks after kidney transplantation and subjects receiving standard dose Advagraf®. Pilot results of safety and efficacy in optimized dose Advagraf® over 52 weeks after kidney transplantation will also be obtained.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
73
oral
Unnamed facility
Seoul, South Korea
Unnamed facility
Taipei, Taiwan
estimated GFR
Time frame: at Week-52 after transplantation
creatinine clearance
Time frame: at Week-52 after transplantation
serum creatinine level
Time frame: at Week-52 after transplantation
Number of graft survival
Time frame: at Week-52 after transplantation
Subject survival
Time frame: at Week-52 after transplantation
number of biopsy-proven acute rejection
Time frame: at Week-52 after transplantation
Composite of graft loss, subject death and biopsy proven acute rejection
Time frame: at Week-52 after transplantation
Time to the first acute rejection
Time frame: up to Week-52 after transplantation
Time to the first steroid-resistant acute rejection
Time frame: up to Week-52 after transplantation
Severity of biopsy proven acute rejection
Severity is evaluated using Banff '07 Criteria
Time frame: up to Week-52 after transplantation
Safety assessed by the incidence of adverse events, vital signs and lab tests
Time frame: for 52 weeks after transplantation
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