The objective of this study is to compare the efficacy and safety between a group that has been on Prograf twice daily therapy but converted to Advagraf once daily therapy and a group that maintained Prograf twice daily therapy.
De novo Liver Transplant Recipients will be divided into two groups. Both groups will receive Prograf (Tacrolimus twice daily therapy), and at Month 1 (Week 4) after surgery, Prograf will be converted to Advagraf (modified release Tacrolimus, once daily) in one group, while Prograf therapy will be continued in other group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Unnamed facility
Seoul, South Korea
Incidence of biopsy-confirmed acute rejection
Acute rejection incidence (%) = Number of subjects with at least one biopsy -confirmed acute rejection / Total number of subjects included in the relevant analysis set \* 100
Time frame: from Week 4 to Week 24 post-transplant
Incidence of biopsy-confirmed acute rejection
Time frame: from Week 4 to Week 12 or Week 24
Severity of biopsy-confirmed acute rejection
Severity guideline is Banff criteria
Time frame: from Week 4 to Week 12 and Week 24 after liver transplant
Subject survival rate and graft survival rate
Time frame: from Week 4 to Week 12 and Week 24 after liver transplant
Safety assessed by the incidence of adverse events, vital signs, physical exam. and labo-tests
Time frame: for 24 weeks after liver transplant
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