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

This study has been completed.
Information provided by (Responsible Party):
Astellas Pharma Inc Identifier:
First received: February 22, 2006
Last updated: August 25, 2014
Last verified: August 2014
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.

Condition Intervention Phase
Liver Transplantation Drug: tacrolimus Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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.

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 acute rejection which requires treatment within 3 months following transplantation [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Acute rejection. Incidence of and time to first acute rejection. Incidence of and time to first corticosteroid-resistant acute rejection. [ Time Frame: 3 months ]

Enrollment: 627
Study Start Date: March 2005
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: tacrolimus
Other Name: Prograf, FK506
Experimental: 2 Drug: tacrolimus
Other Name: Prograf, FK506

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  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 identifier: NCT00295594

  Show 41 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Study Director: Medical Physician Astellas Pharma Europe B.V.
  More Information

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT00295594     History of Changes
Other Study ID Numbers: FG-506-01-27
Study First Received: February 22, 2006
Last Updated: August 25, 2014

Keywords provided by Astellas Pharma Inc:
Liver Transplantation
Treatment Outcome

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on August 17, 2017