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

Astellas Pharma Inc101 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

101

Conditions

LIVER TRANSPLANTATION

Interventions

TACROLIMUSDRUG

Immunosuppression

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

Unnamed facility

Bergamo, Italy

Unnamed facility

Bologna, Italy

Unnamed facility

Milan, Italy

Unnamed facility

Milan, Italy

Outcomes

Primary Outcomes

Incidence of and time to first biopsy-proven and treatment requiring acute rejection

Time frame: 3 months

Secondary Outcomes

Incidence of acute rejection

Time frame: 3 months

Data from ClinicalTrials.gov

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