The purpose of this study is to evaluate the efficacy and safety of conversion to TacroBell slow-release cap.(Once-daily Tacrolimus) in patients undergoing maintenance therapy with Twice-Daily Tacrolimus after liver transplantation.
This study is a multi-center, non-comparative, and phase IV clinical trial that evaluates the efficacy and safety of conversion to TacroBell slow-release cap.(Once-daily Tacrolimus) in patients who have undergone at least one year after liver transplantation and receive maintenance therapy with Twice-Daily Tacrolimus. Enrolled subjects will take TacroBell slow-release cap.(Once-daily Tacrolimus) for 24 weeks and will conduct scheduled tests with four additional visits.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
146
* Orally, once-daily in the morning * The first dose is converted to approximately 100% of the existing daily dose, taking into account the subject's blood concentration, after which the investigator check the blood concentration of tacrolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 3\~10ng/ml.
Samsung Medical Center
Seoul, South Korea
Incidence of composite efficacy failure
composite efficacy failure include biopsy-confirmed acute rejection, graft loss, death, or follow-up failure
Time frame: until 24 weeks
Incidence of biopsy-confirmed acute rejection
episode of biopsy-confirmed acute rejection until 24weeks after conversion
Time frame: until 24 weeks
Pathological results of acute rejection
acute rejection using Banff 2016 Criteria and RAI(Rejection activity index) score; total 0\~9
Time frame: until 24 weeks
Survival rate of transplanted organ
Time frame: at 24 weeks
Survival rate of Patients
Time frame: at 24 weeks
Serum-Cr, eGFR(estimated glomerular filtration rate)
eGFR using MDRD(Modification of Diet in Renal Disease) method
Time frame: at 24 weeks
Evaluate safety of TacroBell SR. cap. from number of participants with adverse events
Time frame: until 24 weeks
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