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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-27

Study Completion Date

2014-05-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Liver Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Intravenous Prograf therapy followed by oral Advagraf therapy

Group Type EXPERIMENTAL

Advagraf

Intervention Type DRUG

oral

Prograf

Intervention Type DRUG

intravenous

Arm 2

Intravenous Prograf therapy followed by oral Prograf therapy

Group Type ACTIVE_COMPARATOR

Prograf

Intervention Type DRUG

oral

Prograf

Intervention Type DRUG

intravenous

Interventions

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Advagraf

oral

Intervention Type DRUG

Prograf

oral

Intervention Type DRUG

Prograf

intravenous

Intervention Type DRUG

Other Intervention Names

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FK506E modified release tacrolimus FK506 tacrolimus tacrolimus FK506

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No