This study's objective is to evaluate the incidence rate of acute rejection reactions after 24 weeks treatment with ADVAGRAF® following 3 months treatment with tacrolimus in new liver transplant recipients. Treatment conversion will take place from twice daily tacrolimus to once daily tacrolimus (ADVAGRAF) 3 months after transplant in new liver transplant recipients.
This is single center,open-label study with ADVAGRAF® Primary endpoint is Incidence rate of biopsy confirmed acute rejection reactions within 24 weeks following conversion+ Incidence rate of acute rejection reactions (%) = number of subjects with at least one acute rejection reaction 1)/total number of subjects in the relevant analysis set \* 100 Only those acute rejection reactions confirmed by biopsy will be acceptable as acute rejection reactions. Administration method is following The total daily dose of 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, starting from Day 1 (at least one hour before breakfast or 2 to 3 hours after breakfast). * Dose adjustment after conversion On Day 1, the total dose will be converted to 1:1. 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\~8ng/ml for 0 to 3 months and then at 5ng/ ml or below for 3 to 6 months of study treatment. * Duration of treatment The investigational product will be administered for 24 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
31
Administration method The total daily dose of 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, starting from Day 1 (at least one hour before breakfast or 2 to 3 hours after breakfast). * Dose adjustment after conversion On Day 1, the total dose will be converted to 1:1. 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\~8ng/ml for 0 to 3 months and then at 5ng/ml or below for 3 to 6 months of study treatment. * Duration of treatment The investigational product will be administered for 24 weeks.
Incidence rate of acute rejection reaction confirmed by biopsy within 24 weeks after conversion
Incidence rate of acute rejection reaction (%) = The number of subjects with at least one acute rejection reaction / Total number of subjects included in the analysis group \* 100 number of subjects in the relevant analysis set \* 100
Time frame: within 24 weeks
Severity of acute rejection reaction confirmed by biopsy within 24 weeks after conversion
Severity of acute rejection reactions is defined as the highest severity in a subject who had at least one acute rejection reaction.
Time frame: within 24 weeks
Survival rates of subjects after conversion
Time frame: at week 24
Survival rate of transplanted organs after conversion
Time frame: at week 24
Blood concentration of tacrolimus
Time frame: at week -4, week 0, week 2, week 4, week 8, week 16 and week 24
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