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 (PANTERA)

NCT00321074 Phase 3 COMPLETED

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.

Details

Lead sponsor	Astellas Pharma Inc
Phase	Phase 3
Status	COMPLETED
Enrolment	101
Start date	2005-05
Completion	2007-10

Conditions

• LIVER TRANSPLANTATION

Interventions

• TACROLIMUS

Primary outcomes

• Incidence of and time to first biopsy-proven and treatment requiring acute rejection — 3 months

Countries

Italy