Tacrolimus and Daclizumab Versus Tacrolimus and Steroids in Liver Recipients Receiving Sub-optimal Grafts
PANTERA
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
1 other identifier
interventional
101
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2005
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 1, 2006
CompletedFirst Posted
Study publicly available on registry
May 3, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedAugust 26, 2014
August 1, 2014
2.4 years
May 1, 2006
August 25, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of and time to first biopsy-proven and treatment requiring acute rejection
3 months
Secondary Outcomes (1)
Incidence of acute rejection
3 months
Study Arms (2)
1
ACTIVE COMPARATOR2
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Unknown Facility
Bergamo, 24122, Italy
Unknown Facility
Bologna, 40138, Italy
Unknown Facility
Milan, 20122, Italy
Unknown Facility
Milan, 20162, Italy
Unknown Facility
Padua, 35128, Italy
Unknown Facility
Roma, 00144, Italy
Unknown Facility
Roma, 00161, Italy
Unknown Facility
Torino, 10126, Italy
Unknown Facility
Udine, 33100, Italy
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Europe B.V.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2006
First Posted
May 3, 2006
Study Start
May 1, 2005
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
August 26, 2014
Record last verified: 2014-08