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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00321074
First received: May 1, 2006
Last updated: December 8, 2008
Last verified: December 2007
History of Changes

May 1, 2006
December 8, 2008
May 2005
October 2007   (final data collection date for primary outcome measure)
Incidence of and time to first biopsy-proven and treatment requiring acute rejection [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00321074 on ClinicalTrials.gov Archive Site
Incidence of acute rejection [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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

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.

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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Liver Transplantation
Drug: TACROLIMUS
Immunosuppression
Other Name: Prograf, FK506
  • Active Comparator: 1
    Intervention: Drug: TACROLIMUS
  • Experimental: 2
    Intervention: Drug: TACROLIMUS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
101
October 2007
October 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00321074
FG-506-01-IT-02
No
Disclosure Office Europe, Astellas Pharma Europe BV
Astellas Pharma Inc
Not Provided
Study Director: Medical Director Astellas Pharma Europe BV
Astellas Pharma Inc
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP