Liver Transplantation
Conditions
Keywords
Prograf, Advagraf, Myfortic
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.
Interventions
Sponsors
Astellas Pharma Taiwan, Inc.
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of biopsy confirmed acute rejection | during the 6 months post-transplant. |
Secondary
| Measure | Time frame |
|---|---|
| Patient and graft survival rates | during the 6 months post-transplant |
| Time to first biopsy confirmed acute rejection episode | during the 6 months post-transplant |
| Incidence of anti-lymphocyte antibody therapy for treatment of rejection | during the 6 months post-transplant. |
| Safety assessed by adverse events, laboratory parameters, physical examinations and vital signs | throughout the study |
Countries
Taiwan
Outcome results
None listed