None listed
Conditions
Interventions
Drug : Taking previous Tacrolimus daily dose, 24weeks, oral, radomization(1:1)
* ADVAGRAF®: 0.5mg, 1mg, 5mg capsule / once daily
* PROGRAF®: 0.5mg, 1mg capsule / twice daily
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A subject is eligible for the study if all of the following apply: ?More than 20 years of age ?A minimum of 12 months post liver transplant ?Average of tacrorimus trough level is 1-10 ng/mL for 12 weeks before screening. ?Female subjects of child bearing potential must have a negative urine or serum pregnancy test prior to enrolment and at the end of study and must agree to practice effective birth control during the study. ?Subjects are stable clinically in the opinion of the investigator. ?Subjects capable of understanding the purpose and risks of the study, having been fully informed and has given written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: A subject will be excluded from participation if any of the following apply: ?Subjects having previously received an organ transplant excluding liver transplant. Or Subjects receiving an auxiliary graft or in whom a bio-artificial liver(cell system) has been used. ?Acute rejection within 12 weeks before screening or acute rejection requiring anti-lymphocyte antibody therapy within 24 weeks before screening. ?Subjects diagnosed new malignant tumor after liver transplantation, with the exception of basalioma or squamous cell carcinoma of the skin that has been treated successfully. ?Subjects allergic to tacrolimus or investigational product. ?Subjects are unstable clinically state in the opinion of the investigator. ?Subjects with any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator. ?Subjects participating or having participated in another clinical trial and/or those taking or having taken an investigational / non-registered drug in the past 28 days. ?Subjects taking forbidden concomitant medications or within 28 days prior to enroll. ?Subjects who are pregnant or breast-feeding mother. ?Subjects known to be HIV positive. ?Subjects unlikely to comply with the visits scheduled in the protocol. ?Subjects with renal dysfunction or serum creatinine > 1.6mg/dL or GFR(MDRD)<30mL/min in the baseline. ?Hepatic dysfunction: rising more than twice the normal range of SGPT/ALT and/or SGOT/AST and/or bilirubin, hepatic cirrhosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of biopsy confirmed acute rejection | — |
Secondary
| Measure | Time frame |
|---|---|
| Severity of biopsy confirmed acute rejection;Subject survival rate;Graft survival rate;Tacrorimus trough level | — |
Countries
Korea, Republic of
Contacts
Public ContactSeul Lee
Samsung Medical Center
Outcome results
None listed