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

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ClinicalTrials.gov Identifier: NCT00321074
Recruitment Status : Completed
First Posted : May 3, 2006
Last Update Posted : August 26, 2014
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

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.


Condition or disease Intervention/treatment Phase
LIVER TRANSPLANTATION Drug: TACROLIMUS Phase 3

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


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2005
Primary Completion Date : October 2007
Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1 Drug: TACROLIMUS
Immunosuppression
Other Name: Prograf, FK506
Experimental: 2 Drug: TACROLIMUS
Immunosuppression
Other Name: Prograf, FK506



Primary Outcome Measures :
  1. Incidence of and time to first biopsy-proven and treatment requiring acute rejection [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Incidence of acute rejection [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00321074


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

Additional Information:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00321074     History of Changes
Other Study ID Numbers: FG-506-01-IT-02
First Posted: May 3, 2006    Key Record Dates
Last Update Posted: August 26, 2014
Last Verified: August 2014

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

Additional relevant MeSH terms:
Tacrolimus
Daclizumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action