Clinical trial NCT00321074: Tacrolimus and Daclizumab Versus Tacrolimus and Steroids in Liver Recipients Receiving Sub-optimal Grafts
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: LIVER TRANSPLANTATION
Keywords: IMMUNOSUPPRESSION
TACROLIMUS
MARGINAL LIVERS
PHARMACOKINETICS
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2006-05-03
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of and time to first biopsy-proven and treatment requiring acute rejection
timeFrame: 3 months
Secondary outcomes:
measure: Incidence of acute rejection
timeFrame: 3 months
Other outcomes:
Locations:
city: Bergamo
country: Italy
city: Bologna
country: Italy
city: Milano
country: Italy
city: Milano
country: Italy
city: Padova
country: Italy
city: Roma
country: Italy
city: Roma
country: Italy
city: Torino
country: Italy
city: Udine
country: Italy
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Medical Director
role: STUDY_DIRECTOR
References: