Tacrolimus and Daclizumab Versus Tacrolimus and Steroids in Liver Recipients Receiving Sub-optimal Grafts

Study Overview
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Brief Summary
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The purpose of the study is to compare the safety and efficacy of two different tacrolimus based immunosuppressive regimens, one in combination with daclizumab, the other in combination with steroids, in recipients of suboptimal livers. Pharmacokinetics of tacrolimus and bile composition will be measured in a subgroup of patients.

Detailed Description
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Open, multicentre, 1:1 randomised, parallel group phase III study to compare safety and efficacy of tacrolimus (FK506) with monoclonal anti-IL2R antibodies (daclizumab) vs tacrolimus (FK506) with steroids and evaluate pharmacokinetics in liver allograft recipients receiving suboptimal livers. Patients receiving primary suboptimal liver allograft transplantation (from donors > 65 years and/or liver macrosteatosis >15%) will be randomised to one of the following treatment arms: Group I: steroid bolus (intraoperative) monoclonal anti-IL2R antibodies (daclizumab) induction tacrolimus Group II: steroid bolus (intraoperative) tacrolimus steroids

Official Title
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AN OPEN, MULTICENTRE, RANDOMISED PARALLEL GROUP CLINICAL STUDY TO COMPARE SAFETY AND EFFICACY OF TACROLIMUS (FK506) WITH MONOCLONAL ANTI-IL2R ANTIBODIES (DACLIZUMAB) VS TACROLIMUS (FK506) WITH STEROIDS AND EVALUATE PHARMACOKINETICS IN LIVER ALLOGRAFT RECIPIENTS RECEIVING SUBOPTIMAL LIVERS

Conditions
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LIVER TRANSPLANTATION

Intervention / Treatment
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* Drug: TACROLIMUS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent Adult patients scheduled to receive a liver transplant Donors older than 65 and/or has liver macrosteatosis >15% Female patients of childbearing potential agree to maintain effective birth control during the study and must have negative pregnancy test at baseline Exclusion Criteria: Patient has previously received or is receiving an organ transplant other than liver, or a liver re-transplantation. Patient has significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, or active peptic ulcer Patient is receiving an auxiliary graft or a bio-artificial liver has been used. Any pathology or medical condition that can interfere with this protocol study proposal Other exclusion applies

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: TACROLIMUS<br>* Immunosuppression<br>* Other names: Prograf, FK506;|
| Experimental: 2<br> | Drug: TACROLIMUS<br>* Immunosuppression<br>* Other names: Prograf, FK506;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of and time to first biopsy-proven and treatment requiring acute rejection |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of acute rejection |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MARGINAL LIVERS, IMMUNOSUPPRESSION, TACROLIMUS, PHARMACOKINETICS