NCT00296309

Comparing Efficacy & Safety of Tacrolimus & MMF With/Without Induction in the Elderly Following Kidney Transplantation.

A Multicentre, Randomised, Open Clinical Study to Compare the Efficacy and Safety of a Combination of Tacrolimus and Mycophenolate Mofetil Based Regimen With or Without Induction in Elderly Recipients Undergoing Kidney Transplantation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 267 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

Primary objective of this study is to compare the renal function as well as the incidence of renal dysfunction, the incidence of death, graft loss and acute rejection. Secondary Objective is to compare the efficacy and safety profiles of the two regimens in elderly renal transplanted patients.

Detailed description

The use of tacrolimus-based primary immunosuppression in elderly renal transplant recipients is efficacious and safe, particularly in combination with MMF, and seems to be associated with lower mortality and graft loss rates than classic cyclosporin protocols. Nevertheless, the efficacy and safety of tacrolimus in monotherapy, double or triple therapy with MMF, as well as the induction therapy with the new anti-IL2 receptor antibodies have not been adequately used in controlled trials in the elderly renal transplant patient. There is only scarce information on age-associated immune responsiveness and only a few aged-adapted immunosuppressive regimens have been described.

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
DRUG	Tacrolimus	Immunosuppression

Timeline

• Start date: 2004-10-01
• Primary completion: 2006-08-01
• Completion: 2006-08-01
• First posted: 2006-02-27
• Last updated: 2014-09-01

Locations

33 sites across 7 countries: Belgium, France, Germany, Netherlands, Spain, Switzerland, United Kingdom