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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00321074

Acronym

PANTERA

Enrollment

101

Registered

2006-05-03

Start date

2005-05-31

Completion date

2007-10-31

Last updated

2014-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

LIVER TRANSPLANTATION

Keywords

IMMUNOSUPPRESSION, TACROLIMUS, MARGINAL LIVERS, PHARMACOKINETICS

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

Interventions

DRUGTACROLIMUS

Immunosuppression

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Incidence of acute rejection	3 months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026