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

Astellas

Status and phase: Completed; Phase 4

Conditions: Liver Transplantation

Treatments: Drug: Prograf; Drug: Advagraf

Study type: Interventional

Funder types: Industry

Identifiers

NCT01339468

MR-08-04-KOR_Main

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Arm 1

Experimental group

Description:

Intravenous Prograf therapy followed by oral Advagraf therapy

Treatment:

Drug: Advagraf

Drug: Prograf

Drug: Prograf

Arm 2

Active Comparator group

Description:

Intravenous Prograf therapy followed by oral Prograf therapy

Treatment:

Drug: Prograf

Drug: Prograf