NCT00321113

Comparison of Two Tacrolimus Based Immunosuppressive Regimens in Recipients Receiving Marginal Donor Kidneys

An Open, Multicentre, Randomised, Parallel Group Study to Compare in Marginal Old-for-old Renal Transplant Patients the Safety and Efficacy of Two Treatments: Sequential Mycophenolate Mofetil/Delayed Tacrolimus Plus Steroids vs Tacrolimus Plus Mycophenolate Mofetil in Patients Requiring Induction With Anti-IL2 Antibody

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to explore the safety and efficacy of two different immunosuppressive regimens (sequential tacrolimus/mycophenolate mofetil \[MMF\] plus steroids versus tacrolimus plus MMF, following induction with daclizumab) in recipients of marginal donor kidneys.

Detailed description

An open, multicentre, randomized, parallel group study to compare in marginal old-for-old renal transplant patients the safety and efficacy of two treatments: sequential mycophenolate mofetil/delayed tacrolimus plus steroids vs tacrolimus plus mycophenolate mofetil, in patients requiring induction with anti-IL2 monoclonal antibody. Elderly (≥50 years) low risk patients (PRA grade ≤50%, in the previous 6 months) receiving an allograft transplantation of marginal kidney(s) from elderly (\>65 years) donors (old-for-old allocation) will be randomized to one of the following treatment arms: Arm1: Sequential mycophenolate mofetil/tacrolimus/steroids Arm2: Tacrolimus/mycophenolate mofetil/steroid one single dose (perioperatively)

Conditions

• KIDNEY TRANSPLANTATION

Interventions

Type	Name	Description
DRUG	tacrolimus	immunosuppression
DRUG	mycophenolate mofetil	oral
DRUG	steroids	oral

Timeline

• Start date: 2004-09-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2006-05-03
• Last updated: 2017-02-24

Locations

14 sites across 1 country: Italy