NCT00321074

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• LIVER TRANSPLANTATION

Interventions

Type	Name	Description
DRUG	TACROLIMUS	Immunosuppression

Timeline

• Start date: 2005-05-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2006-05-03
• Last updated: 2014-08-26

Locations

9 sites across 1 country: Italy