A Randomized Study to Assess the Safety and Efficacy of Prograf vs Prograf-XL in de Novo Liver Transplant Recipients.

Study Overview
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Brief Summary
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The purpose of this study is to compare the efficacy and safety of Prograf extended release(XL) plus MMF with Prograf plus MMF and steroid withdrawal 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)/MMF and Extended Release (XL) Tacrolimus /MMF and Steroid Withdraw in de Novo Liver Transplant Recipients.

Conditions
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Liver Transplantation, Transplantation Immunology, Host vs Graft Reaction

Intervention / Treatment
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* Drug: Prograf-XL
* Drug: Prograf
* Drug: MMF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has been fully informed and has signed an IRB approved informed consent form and is willing and able to follow study procedures Patient is a primary liver transplant recipient Patient must receive first dose of XL or Prograf (or IV tacrolimus for subjects unable to tolerate oral study drug) within 48 hours of transplantation Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to transplant Exclusion Criteria: Patient has previously received or is receiving an organ transplant other than a liver Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV) Patient has received a liver transplant from a non-heart beating donor Patient has received an ABO incompatible donor liver Patient has a current malignancy or a history of malignancy (within the past 5 years), except hepatocellular carcinoma within UCSF Criteria 21 and basal or non-metastatic squamous cell carcinoma of skin that has been treated successfully 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 has severe diarrhea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus 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, mycophenolate mofetil or corticosteroids Patient is pregnant or lactating Patient is unlikely to comply with the visits scheduled in the protocol, including the protocol biopsies Patient has any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication with the investigator

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 |
| --- | --- |
| Experimental: Prograf-XL + MMF<br> | Drug: Prograf-XL<br>* oral<br>* Other names: MR4;Drug: MMF<br>* oral<br>* Other names: Mycophenolate Mofetil;|
| Active Comparator: Prograf + MMF<br> | Drug: Prograf<br>* oral<br>* Other names: FK506;Drug: MMF<br>* oral<br>* Other names: Mycophenolate Mofetil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of biopsy confirmed acute rejection (local assessment of biopsies performed due to hepatic dysfunction) during the 6 months post-transplant. |  | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient and graft survival rates during the 6 and 12 months post-transplant |  | 6 and 12 month | 
| Incidence of biopsy confirmed acute rejection (local assessment of biopsies performed due to hepatic dysfunction) during the 12 months post-transplant |  | 12 month | 
| Incidence of anti-lymphocyte antibody therapy for treatment of rejection during the 6 and 12 months post-transplant |  | 6 and 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunosuppressant, Graft loss, Combination drug therapy, Randomized controlled trial, Open level method