Clinical trial NCT01339468: A Study to Assess the Pharmacokinetics, Safety and Efficacy of Advagraf and Prograf in de Novo Liver Transplantation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Liver Transplantation
Keywords: advagraf
prograf
living donor liver transplantation
FK506
Immunosuppressant
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2011-04-20
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: AUC0-24 (Area under the curve for 24 hours) of tacrolimus plasma concentration
timeFrame: Day 6 and day 21
Secondary outcomes:
measure: Cmax (maximum concentration) of tacrolimus plasma concentration
timeFrame: Day 6 and day 21
measure: Incidence of the composite event: graft loss (defined as re-transplantation or death) or biopsy confirmed acute rejection (BCAR)
timeFrame: up to 24 weeks
measure: Time to first incidence of the composite event: graft loss (defined as re-transplantation or death) or biopsy confirmed acute rejection (BCAR)
timeFrame: up to 24 weeks
measure: Safety assessed by the incidence of adverse events and lab-tests
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
citation: Shin MH, Song GW, Lee SG, Hwang S, Kim KH, Ahn CS, Moon DB, Ha TY, Jung DH, Park GC, Yun YI, Kim WJ, Kang WH, Kim SH, Jiang H, Lee S, Tak EY. Once-daily, prolonged-release tacrolimus vs twice-daily, immediate-release tacrolimus in de novo living-donor liver transplantation: A Phase 4, randomized, open-label, comparative, single-center study. Clin Transplant. 2018 Sep;32(9):e13376. doi: 10.1111/ctr.13376. Epub 2018 Aug 26.