Comparing Efficacy & Safety of Tacrolimus With/Without MMF or Monoclonal Anti-IL2R Antibody in Liver Transplantation. (MARSILEA)

August 25, 2014 updated by: Astellas Pharma Inc

An Open, Randomised, Multicenter, Clinical Study to Compare the Safety and Efficacy of Tacrolimus and Minimal Steroids in Combination With Either a Monoclonal Anti-IL2R Antibody (Daclizumab) or Mycophenolate Mofetil in Liver Allograft Transplantation.

To compare the efficacy and safety of two regimens containing tacrolimus and minimal steroids together with either monoclonal anti-IL2R antibodies (daclizumab) or mycophenolate mofetil.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This prospective randomised trial which combines MMF with tacrolimus and so avoids steroids in immunosuppressive maintenance could demonstrate alternatives to current immunosuppressive regimens. There is evidence that reduced steroid usage could further decrease the onset of diabetes mellitus, hypertension and viral infections combined with high efficacy for patients and graft survival. Since the use of MMF in liver transplantation is becoming an alternative in the rescue setting this could contribute to a steroid-free immunosuppressive approach.

Study Type

Interventional

Enrollment (Actual)

627

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Gent, Belgium, 9000
      • Leuven, Belgium, 3000
      • Liege, Belgium
  • Denmark
      • Copenhagen, Denmark
  • Finland
      • Helsinki, Finland, 00130
  • Germany
      • Bonn, Germany, 53105
      • Erlangen, Germany, 91054
      • Essen, Germany, 45122
      • Hamburg, Germany, 20251
      • Hannover, Germany, 30625
      • Kiel, Germany, 24105
      • Mainz, Germany, 55131
  • Hungary
      • Budapest, Hungary, 1082
  • Italy
      • Bari, Italy, 70124
      • Bergamo, Italy, 24128
      • Milano, Italy, 20122
      • Milano, Italy, 20162
      • Napoli, Italy, 80131
      • Padova, Italy, 35128
      • Palermo, Italy, 90134
      • Udine, Italy, 33100
  • Poland
      • Szczecin, Poland, 71-455
      • Wroclaw, Poland, 50-326
  • Spain
      • Barcelona, Spain, 08035
      • Cordoba, Spain, 14004
      • Granada, Spain, 18012
      • La Coruna, Spain, 15006
      • Madrid, Spain, 28034
      • Madrid, Spain, 28007
      • Madrid, Spain, 28035
      • Murcia, Spain, 30120
      • Pamplona, Spain, 31008
      • Santiago, Spain, 15706
      • Sevilla, Spain, 41013
      • Valencia, Spain, 46009
  • Sweden
      • Goteborg, Sweden, 41345
      • Uppsala, Sweden, 75105
  • Switzerland
      • Bern, Switzerland, 3010
      • Zurich, Switzerland, 8091
  • United Kingdom
      • Leeds, United Kingdom
      • Newcastle, United Kingdom

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients 18 years of age or older who will undergo primary orthotopic liver or split liver allograft transplantation are eligible for the study. Patients receiving a liver transplant from cadaveric heart-beating donor with compatible AB0 blood type can be included.

Exclusion Criteria:

  • Recipient of an auxiliary graft
  • Patient is requiring initial sequential or parallel therapy with other immunosuppressive antibody preparation(s).
  • Patient is requiring ongoing dosing with corticosteroids.
  • Patient is exhibiting symptoms of, or is having any previous history of neoplastic disease
  • Patient or donor is known to be HIV positive.
  • Patient is allergic or intolerant to study medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2
Drug: tacrolimus
Immunosuppression
Other Names:
  • Prograf, FK506
Active Comparator: 1
Drug: tacrolimus
Immunosuppression
Other Names:
  • Prograf, FK506

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of and time to first biopsy proven acute rejection which requires treatment within 3 months following transplantation
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Acute rejection. Incidence of and time to first acute rejection. Incidence of and time to first corticosteroid-resistant acute rejection.
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Investigators

  • Study Director: Medical Physician, Astellas Pharma Europe B.V.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

February 22, 2006

First Submitted That Met QC Criteria

February 22, 2006

First Posted (Estimate)

February 24, 2006

Study Record Updates

Last Update Posted (Estimate)

August 26, 2014

Last Update Submitted That Met QC Criteria

August 25, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FG-506-01-27

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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