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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.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00295594
First received: February 22, 2006
Last updated: December 3, 2008
Last verified: December 2008
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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
Immunosuppression
Other Name: Prograf, FK506
Experimental: 2 Drug: tacrolimus
Immunosuppression
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.

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00295594

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

Additional Information:
Link to FDA website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Astellas Disclosure Office, Astellas Pharma Europe BV
ClinicalTrials.gov Identifier: NCT00295594     History of Changes
Other Study ID Numbers: FG-506-01-27
Study First Received: February 22, 2006
Last Updated: December 3, 2008
Health Authority: Switzerland: Swissmedic

Keywords provided by Astellas Pharma Inc:
Tacrolimus
Liver Transplantation
Treatment Outcome
Immunosuppression

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

ClinicalTrials.gov processed this record on May 19, 2013