A Study to Compare Safety and Efficacy of Prograf + Myfortic and Advagraf + Myfortic in Liver Transplantation Patients

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

Official Title
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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

Conditions
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Liver Transplantation

Intervention / Treatment
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* Drug: Prograf
* Drug: Advagraf
* Drug: Myfortic


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prograf with Myfortic<br> | Drug: Prograf<br>* oral<br>* Other names: FK506;Drug: Myfortic<br>* oral<br>* Other names: Mycophenolate sodium;|
| Experimental: Advagraf with Myfortic<br> | Drug: Advagraf<br>* oral<br>* Other names: MR4;Drug: Myfortic<br>* oral<br>* Other names: Mycophenolate sodium;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of biopsy confirmed acute rejection |  | during the 6 months post-transplant. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prograf, Advagraf, Myfortic