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

NCT ID: NCT00295594

Last Updated: 2014-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 627 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2007-06-30

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.

Conditions

Liver Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

Group Type: ACTIVE_COMPARATOR

tacrolimus

Intervention Type: DRUG

Immunosuppression

2

Group Type: EXPERIMENTAL

tacrolimus

Intervention Type: DRUG

Immunosuppression

Interventions

tacrolimus

Immunosuppression

Intervention Type: DRUG

Other Intervention Names

Prograf, FK506

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Physician

Role: STUDY_DIRECTOR

Astellas Pharma Europe B.V.

Locations

Ghent, , Belgium

Leuven, , Belgium

Liège, , Belgium

Copenhagen, , Denmark

Helsinki, , Finland

Bonn, , Germany

Erlangen, , Germany

Essen, , Germany

Hamburg, , Germany

Hanover, , Germany

Kiel, , Germany

Mainz, , Germany

Budapest, , Hungary

Bari, , Italy

Bergamo, , Italy

Milan, , Italy

Milan, , Italy

Napoli, , Italy

Padua, , Italy

Palermo, , Italy

Udine, , Italy

Szczecin, , Poland

Wroclaw, , Poland

A Coruña, , Spain

Barcelona, , Spain

Córdoba, , Spain

Granada, , Spain

Madrid, , Spain

Madrid, , Spain

Madrid, , Spain

Murcia, , Spain

Pamplona, , Spain

Santiago, , Spain

Seville, , Spain

Valencia, , Spain

Gothenburg, , Sweden

Uppsala, , Sweden

Bern, , Switzerland

Zurich, , Switzerland

Leeds, , United Kingdom

Newcastle, , United Kingdom

Countries

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

Related Links

http://www.accessdata.fda.gov/scripts/cder/drugsatfda

Link to FDA website

Other Identifiers

FG-506-01-27

Identifier Type: -

Identifier Source: org_study_id