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

Liver Transplantation Clinical Trial

— MARSILEA  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00295594
• Other study ID #: FG-506-01-27
• Status: Completed
• Phase: Phase 3
• First received: February 22, 2006
• Last updated: August 25, 2014
• Start date: March 2005
• Est. completion date: June 2007

Study information

• Verified date: August 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 627
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

Drug:
• tacrolimus
Immunosuppression

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of and time to first biopsy proven acute rejection which requires treatment within 3 months following transplantation		3 months	No
Secondary	Acute rejection. Incidence of and time to first acute rejection. Incidence of and time to first corticosteroid-resistant acute rejection.		3 months	No

External Links

•   Link to FDA website
•   Link to Results on JAPIC - enter 140555 in the JapicCTI-RNo. field