Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00284934
Status:
COMPLETED
Last Update Posted:
2011-05-02
First Post:
2006-01-30
Brief Title:
Enteric-coated Mycophenolate Sodium EC-MPS With Reduced-dose Tacrolimus Versus EC-MPS With Standard-dose Tacrolimus in Stable Kidney Transplant Recipients
Sponsor:
Novartis
Organization:
Novartis
Study Overview
Official Title:
A Multicenter National Open-label Prospective Randomized Study to Evaluate Efficacy and Tolerability of Enteric-coated Mycophenolate Sodium 1440 mgDay With Tacrolimus Reduced Dose Versus Enteric-coated Mycophenolate Sodium 720 mgDay With Tacrolimus Standard Dose in Maintenance Stable Adult Kidney Transplant Recipients
Status:
COMPLETED
Status Verified Date:
2011-03
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:
OLYMPE
Brief Summary:
This study introduces a new optimization immunosuppressive regimen associating tacrolimus at a reduced dose and enteric-coated mycophenolate sodium at an increased dose in order to slow down renal function worsening and to prevent the progression of chronic allograft nephropathy while maintaining the same efficacy in maintenance renal transplant recipients
Detailed Description:
None
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