Liver Transplantation
Conditions
Keywords
advagraf, prograf, living donor liver transplantation, FK506, Immunosuppressant
Brief summary
The purpose of this study is to investigate and compare the pharmacokinetic parameters of tacrolimus from Advagraf and Prograf in de nove living donor liver transplant recipients.
Interventions
DRUGAdvagraf
oral
DRUGPrograf
oral
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* subject receiving a primary, partial liver graft from a living donor * subject must receive the first dose of tacrolimus and corticosteroids after operation and are expected to be maintained on tacrolimus throughout the study. MMF could be combined
Exclusion criteria
* subjects receiving a multi-organ transplant or having previously received an organ transplant (including liver re-transplantation) * subjects receiving an auxiliary graft or in whom a bio-artificial liver (cell system) has been used * subjects allergic or intolerant to macrolide antibiotics or tacrolimus * subjects requiring immunosuppressive treatment and / or systemic chemotherapy prior to transplantation * subjects with malignancies or a history of malignancy within the last 5 years, with the exception of those with basalioma or squamous cell carcinoma of the skin * subjects with systemic infection requiring treatment, except viral hepatitis * subjects with severe diarrhoea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus * subjects with serum creatinine \> 1.5mg/dl * subjects taking or having taken potassium preserved diuretics * 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 or donors known to be HIV positive * donors known to be HBV, HCV positive and/or IgM positive of CMV, EBV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-24 (Area under the curve for 24 hours) of tacrolimus plasma concentration | Day 6 and day 21 |
Secondary
| Measure | Time frame |
|---|---|
| Safety assessed by the incidence of adverse events and lab-tests | up to 24 weeks |
| Cmax (maximum concentration) of tacrolimus plasma concentration | Day 6 and day 21 |
| Incidence of the composite event: graft loss (defined as re-transplantation or death) or biopsy confirmed acute rejection (BCAR) | up to 24 weeks |
| Time to first incidence of the composite event: graft loss (defined as re-transplantation or death) or biopsy confirmed acute rejection (BCAR) | up to 24 weeks |
Countries
South Korea
Outcome results
None listed