Clinical trial NCT01018914: A Study to Compare Safety and Efficacy of Prograf + Myfortic and Advagraf + Myfortic in Liver Transplantation Patients
Official title: A Randomized, Open-Label, Comparative, Multi-Center Study to Assess the Safety and Efficacy of Prograf® (Tacrolimus)/ Myfortic® and Advagraf® (Extended Release Tacrolimus) / Myfortic® in de Novo Liver Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Liver Transplantation
Keywords: Prograf
Advagraf
Myfortic
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Taiwan, Inc.
First posted: 2009-11-25
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the safety and efficacy of Prograf® with Myfortic® to Advagraf® extended release tacrolimus with Myfortic® in de novo liver transplant recipients.


Eligibility criteria: Inclusion Criteria:

* Patient is a primary liver transplant recipient
* Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to transplant
* Patient has been fully informed and has signed an IRB approved informed consent form and is willing and able to follow study procedures
* Patient must receive 1st dose of study drug within 24 hours of pre-transplantation

Exclusion Criteria:

* Patient has previously received or is receiving an organ transplant other than a liver
* Patient currently requires dialysis
* Patient has received a liver transplant from a non-heart beating donor
* Patient has received an ABO incompatible donor liver
* Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV)
* Patient has fulminant hepatic failure, unless hemodynamically stable
* Patient has an uncontrolled concomitant infection, a systemic infection requiring treatment (except viral hepatitis), or any other unstable medical condition that could interfere with the study objectives
* Patient is currently taking or has been taking an investigational drug in the 30 days prior to transplant
* Patient has a known hypersensitivity to tacrolimus, enteric-coated mycophenolate sodium or corticosteroids
* Patient is pregnant or lactating

Primary outcomes:
measure: Incidence of biopsy confirmed acute rejection
timeFrame: during the 6 months post-transplant.
Secondary outcomes:
measure: Patient and graft survival rates
timeFrame: during the 6 months post-transplant
measure: Time to first biopsy confirmed acute rejection episode
timeFrame: during the 6 months post-transplant
measure: Incidence of anti-lymphocyte antibody therapy for treatment of rejection
timeFrame: during the 6 months post-transplant.
measure: Safety assessed by adverse events, laboratory parameters, physical examinations and vital signs
timeFrame: throughout the study
Other outcomes:
Locations:
city: Taichung
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References: