A Study to Compare Safety and Efficacy of Prograf + Myfortic and Advagraf + Myfortic in Liver Transplantation Patients
Phase 4
Completed
- Conditions
- Liver Transplantation
- Interventions
- Registration Number
- NCT01018914
- Lead Sponsor
- Astellas Pharma Inc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Advagraf with Myfortic Advagraf - Prograf with Myfortic Prograf - Prograf with Myfortic Myfortic - Advagraf with Myfortic Myfortic -
- Primary Outcome Measures
Name Time Method Incidence of biopsy confirmed acute rejection during the 6 months post-transplant.
- Secondary Outcome Measures
Name Time Method 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