Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00121810
Status:
COMPLETED
Last Update Posted:
2011-04-15
First Post:
2005-07-15
Brief Title:
Kidney Spare the Nephron STN Study - A Study of CellCept Mycophenolate Mofetil and Rapamune Sirolimus in Kidney Transplant Recipients
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
An Open Label Randomized Multicenter Study to Evaluate the Efficacy and Safety of Early Calcineurin Inhibitor Withdrawal in Recipients of Primary Renal Allografts Maintained Long-term on Mycophenolate Mofetil MMF CellCept and Sirolimus Rapamune
Status:
COMPLETED
Status Verified Date:
2011-04
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:
None
Brief Summary:
This 2-arm study recruited kidney transplant patients who were receiving standard care of calcineurin inhibitors CNIs tacrolimus or cyclosporine CellCept 10-15 g twice daily and corticosteroids They were either randomized to continue this regimen or CNI therapy was discontinued and replaced by sirolimus therapy in combination with CellCept and corticosteroids The effect of these 2 regimens on efficacy safety and kidney function was evaluated The anticipated time on study treatment was 1-2 years and the target sample size was 100-500 individuals
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