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

Phase 3

Completed

• Conditions: LIVER TRANSPLANTATION
• Interventions: Drug: TACROLIMUS

• Registration Number: NCT00321074
• Lead Sponsor: Astellas Pharma Inc

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

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2006-05-01
• Study First Submitted QC: 2006-05-01
• Study First Posted: 2006-05-03
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-25
• Last Update Posted: 2014-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	TACROLIMUS	-
2	TACROLIMUS	-

Primary Outcome Measures

Name	Time	Method
Incidence of and time to first biopsy-proven and treatment requiring acute rejection	3 months

Secondary Outcome Measures

Name	Time	Method
Incidence of acute rejection	3 months