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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00321074
First received: May 1, 2006
Last updated: August 25, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
LIVER TRANSPLANTATION
Drug: TACROLIMUS
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Incidence of and time to first biopsy-proven and treatment requiring acute rejection [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of acute rejection [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 101
Study Start Date: May 2005
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: TACROLIMUS
Immunosuppression
Other Name: Prograf, FK506
Experimental: 2 Drug: TACROLIMUS
Immunosuppression
Other Name: Prograf, FK506

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00321074

Locations
Italy
Bergamo, Italy, 24122
Bologna, Italy, 40138
Milano, Italy, 20162
Milano, Italy, 20122
Padova, Italy, 35128
Roma, Italy, 00161
Roma, Italy, 00144
Torino, Italy, 10126
Udine, Italy, 33100
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Medical Director Astellas Pharma Europe B.V.
  More Information

Additional Information:
No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00321074     History of Changes
Other Study ID Numbers: FG-506-01-IT-02
Study First Received: May 1, 2006
Last Updated: August 25, 2014
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Astellas Pharma Inc:
IMMUNOSUPPRESSION
TACROLIMUS
MARGINAL LIVERS
PHARMACOKINETICS

Additional relevant MeSH terms:
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014