A Study to Assess the Pharmacokinetics, Safety and Efficacy of Advagraf and Prograf in de Novo Liver Transplantation

• Status: Completed
• Trial end date: 2014-05-27
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Tacrolimus

Criteria

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