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

Liver Transplantation Clinical Trial

— MAIN  

Official title:

A Phase IV, Randomized, Open-label, Comparative, Single-center Study to Assess the Pharmacokinetics, Safety and Efficacy of Advagraf® (Modified Release Tacrolimus) and Prograf® (Tacrolimus) in de Novo Living Donor Liver Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01339468
• Other study ID #: MR-08-04-KOR_Main
• Status: Completed
• Phase: Phase 4
• First received: April 12, 2011
• Last updated: July 17, 2017
• Start date: April 27, 2011
• Est. completion date: May 27, 2014

Study information

• Verified date: July 2017
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 27, 2014
• Est. primary completion date: May 27, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

Drug:
• Advagraf
oral
• Prograf
oral
• Prograf
intravenous

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC0-24 (Area under the curve for 24 hours) of tacrolimus plasma concentration		Day 6 and day 21
Secondary	Cmax (maximum concentration) of tacrolimus plasma concentration		Day 6 and day 21
Secondary	Incidence of the composite event: graft loss (defined as re-transplantation or death) or biopsy confirmed acute rejection (BCAR)		up to 24 weeks
Secondary	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
Secondary	Safety assessed by the incidence of adverse events and lab-tests		up to 24 weeks

External Links

•   Link to results on Astellas Clinical Study Results website
•   Link to results on Astellas Clinical Study Results website