NCT00295594

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 627 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	tacrolimus	Immunosuppression

Timeline

• Start date: 2005-03-01
• Primary completion: 2007-06-01
• Completion: 2007-06-01
• First posted: 2006-02-24
• Last updated: 2014-08-26

Locations

41 sites across 11 countries: Belgium, Denmark, Finland, Germany, Hungary, Italy, Poland, Spain, Sweden, Switzerland, United Kingdom