A Study to Assess the Safety and Efficacy of Prograf and MR4 in Liver Transplant Recipients

Study Overview
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Brief Summary
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To evaluate and to compare efficacy and safety of MR4 versus Prograf in patients undergoing primary liver transplantation.

Official Title
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A Phase III, Randomized, Open-Label, Comparative, Multi-Center Study to Assess the Safety and Efficacy of Prograf® (Tacrolimus) and MR4 (Modified Release Tacrolimus) in de Novo Liver Transplant Recipients

Conditions
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Liver Transplantation

Intervention / Treatment
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* Drug: Prograf
* Drug: MR4


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients of child bearing potential must have a negative in pregnancy test prior to enrollment and must agree to practice effective birth control during the study Patients who need liver transplantation due to the end-stage liver failure Exclusion Criteria: Patients receiving multi-organ transplant or having previously received an organ transplant ( including re-transplantation) Patients receiving auxiliary graft or in whom a bio-artificial Patients allergic to macrolide antibiotics or tacrolimus Patients requiring immunosuppressive treatment or systemic chemotherapy prior to transplantation. Patients requiring low level immunosuppressive treatment ( MMF, steroids, azathioprine ) before transplantation to control their original liver disease can be included in the study, provided that this treatment is discontinued at the time of transplantation. Local chemotherapy is allowed Patients with malignancies of a history of malignancy within the last 5 years, with the exception of those with basalioma or squamous cell carcinoma of the skin that has been treated successfully Patients can be included under Milan Criteria Patients with malignancy which was identified after completion of surgery e.g. by histopathology will be allowed to remain in the study Patients with systemic infection requiring treatment, except viral hepatitis Patients with severe diarrhea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus Patients with serum creatinine > 1.5mg/Dl Patients with any form of substance abuse, psychiatric disorder of condition which, in the opinion of the investigator, may complicate communication with the investigator Patients participating or participated in another clinical trial or those taking or having taken an investigational / non-registered drug in the past 28 days Patients who are pregnant or breast-feeding mother Patients or donors known to be HIV positive Patients unlikely to comply with the visits scheduled in the protocol

Ages Eligible for Study
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Minimum Age: 18 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: 1<br> | Drug: Prograf<br>* oral<br>* Other names: FK506;|
| Experimental: 2<br> | Drug: MR4<br>* oral<br>* Other names: FK506E;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event rate of patients with biopsy-proven acute rejections |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of and time to acute rejections and corticosteroid resistant acute rejections |  | 12 and 24 weeks | 
| Severity of biopsy-proven acute rejections. |  | 24 weeks | 
| Patient and graft survival |  | 12 and 24 weeks | 
| Incidence of adverse events |  | Throughout trial | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Organ transplantation, Tacrolimus, Prograf, MR4