Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00321113
Status:
COMPLETED
Last Update Posted:
2017-02-24
First Post:
2006-05-01
Brief Title:
Comparison of Two Tacrolimus Based Immunosuppressive Regimens in Recipients Receiving Marginal Donor Kidneys
Sponsor:
Astellas Pharma Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
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 MofetilDelayed Tacrolimus Plus Steroids vs Tacrolimus Plus Mycophenolate Mofetil in Patients Requiring Induction With Anti-IL2 Antibody
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TIGRE
Brief Summary:
The purpose of this study is to explore the safety and efficacy of two different immunosuppressive regimens sequential tacrolimusmycophenolate 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 mofetildelayed 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 kidneys from elderly 65 years donors old-for-old allocation will be randomized to one of the following treatment arms
Arm1 Sequential mycophenolate mofetiltacrolimussteroids
Arm2 Tacrolimusmycophenolate mofetilsteroid one single dose perioperatively
Elderly 50 years low risk patients PRA grade 50 in the previous 6 months receiving an allograft transplantation of marginal kidneys from elderly 65 years donors old-for-old allocation will be randomized to one of the following treatment arms
Arm1 Sequential mycophenolate mofetiltacrolimussteroids
Arm2 Tacrolimusmycophenolate mofetilsteroid one single dose perioperatively
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None