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

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00295594

Acronym

MARSILEA

Enrollment

627

Registered

2006-02-24

Start date

2005-03-31

Completion date

2007-06-30

Last updated

2014-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Transplantation

Keywords

Tacrolimus, Liver Transplantation, Treatment Outcome, Immunosuppression

Brief summary

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.

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.

Interventions

DRUGtacrolimus

Immunosuppression

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Belgium, Denmark, Finland, Germany, Hungary, Italy, Poland, Spain, Sweden, Switzerland, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026