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

Phase 4

Completed

• Conditions: Liver Transplantation
• Interventions: Drug: Prograf; Drug: Advagraf

• Registration Number: NCT01339468
• Lead Sponsor: Astellas Pharma Inc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-12
• Study First Submitted QC: 2011-04-19
• Study First Posted: 2011-04-20
• Study Start: 2011-04-27
• Primary Completion: 2014-05-27
• Study Completion: 2014-05-27
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-17
• Last Update Posted: 2017-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Prograf	Intravenous Prograf therapy followed by oral Prograf therapy
Arm 1	Advagraf	Intravenous Prograf therapy followed by oral Advagraf therapy
Arm 1	Prograf	Intravenous Prograf therapy followed by oral Advagraf therapy

Primary Outcome Measures

Name	Time	Method
AUC0-24 (Area under the curve for 24 hours) of tacrolimus plasma concentration	Day 6 and day 21

Secondary Outcome Measures

Name	Time	Method
Cmax (maximum concentration) of tacrolimus plasma concentration	Day 6 and day 21
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
Safety assessed by the incidence of adverse events and lab-tests	up to 24 weeks
Incidence of the composite event: graft loss (defined as re-transplantation or death) or biopsy confirmed acute rejection (BCAR)	up to 24 weeks