The primary objective of this study is to evaluate the efficacy of 6-month treatment with Advagraf® converted from 12-month treatment with tacrolimus in stable liver transplant recipients. The secondary objective of this study is to evaluate severity of acute rejection confirmed by biopsy in 24 weeks, incidence of chronic rejection, patient and graft survival rates in 24 weeks, incidence of adverse events, blood pressure, tacrolimus trough level, drug compliance, and adherence.
This is single-center, single-group, open-label study, phase 4 IIT. The Subject is transplantated liver at a minimum of 12 month of screening and at least 12 month Treatment with a Tacrolimus stably And start screening after obtain consent to participate in clinical trials, if appropriate in the selection criteria do not apply to the exclusion criteria are enrolled in clinical trials. Administration method is following : The total daily dose of -1 tacrolimus will be converted to 1:1 (mg:mg) and the total daily dose of ADVAGRAF® will be administered only once daily in the morning for 24 weeks, starting from Day 0. Researchers must check the blood concentration of tacrolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 5\~10ng/ml of study treatment. Duration of treatment : The investigational product will be administered for 24 weeks. Tacrorimus blood level is 3-10 ng/ml for 6 months prior to screening and during the maintenance therapy. It is recommended to check the blood concentration of tacrolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 5\~10ng/ml of study treatment. (The lowest blood levels shall be adjusted at the discretion of the researchers, taking a blood sample is carried out in the morning before have of Investigational Product) Subjects, who participated in this clinical trial, are scheduled up to 5 times, and it will be proceed for 24 weeks. (screening and baseline, 3 weeks, 12 weeks, 24 weeks) admitted for 24 weeks including a screening visit.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
101
Researchers must check the blood concentration of tacrolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 5\~10ng/ml of study treatment. Duration of treatment The investigational product will be administered for 24 weeks. (The lowest blood levels shall be adjusted at the discretion of the researchers, taking a blood sample is carried out in the morning before administrated of Investigational Product) Tacrolimus blood level is 3-10 ng/ml for 6 months prior to screening and during the maintenance therapy. ( ① -1day to enrollment : swich to the day before ADVAGRAF®, ② 0day to enrollment : the day swich to ADVAGRAF® ) Duration of treatment the investigational product will be administered for 24 weeks.
Seoul Asan Medical Center
Seoul, South Korea
Incidence of acute rejection confirmed by biopsy in 24 weeks after conversion
* Incidence of acute rejection (%) = no. of subjects who had acute rejection at least once / no. of all the subjects in the relevant analysis set \* 100 * Only acute rejection confirmed by biopsy will be recognized. * In addition, concomitant immunosuppressants other than tacrolimus will be divided into sub-groups (by type and dosage/administration), and point estimation and calculation of 95% two-sided confidence interval will be conducted for incidence of acute rejection.
Time frame: within 24 weeks
Severity of acute rejection confirmed by biopsy in 24 weeks after conversion
\* For the subjects who developed acute rejection at least once, severity of acute rejection is defined as the highest severity.
Time frame: within 24 weeks
Incidence of chronic rejection
\* Chronic rejection will be confirmed by biopsy.
Time frame: within 24 weeks
Patient and graft survival rates in 24 weeks after conversion
Time frame: within 24 weeks
Time from conversion to onset of acute rejection
Time frame: within 24 weeks
Tacrolimus trough level at each visit
Time frame: within 24 weeks
Incidence of adverse events
Time frame: within 24 weeks
Tacrolimus compliance
Evaluation of adherence through a subject questionnaire
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: within 24 weeks