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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:
ClinicalTrials.gov Identifier:
NCT00295594
First Posted: February 24, 2006
Last Update Posted: August 26, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Astellas Pharma Inc
  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
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
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

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:

  • 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
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): NCT00295594


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

Additional Information:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00295594     History of Changes
Other Study ID Numbers: FG-506-01-27
First Submitted: February 22, 2006
First Posted: February 24, 2006
Last Update Posted: August 26, 2014
Last Verified: August 2014

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

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