Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00228020
Status:
COMPLETED
Last Update Posted:
2010-08-25
First Post:
2005-09-26
Brief Title:
Study of Safety and Efficacy of a Basiliximab Mycophenolate Mofetil Cyclosporine Microemulsion and Prednisone Combination Treatment Regimen in Pediatric Renal Allograft Recipients
Sponsor:
Novartis
Organization:
Novartis
Study Overview
Official Title:
A Randomized Placebo-controlled Double-blind Multicenter Study Investigating Basiliximab in Combination With MMF Cyclosporine Microemulsion and Prednisone in the Prevention of Acute Rejection in Pediatric Renal Allograft Recipients
Status:
COMPLETED
Status Verified Date:
2010-08
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:
The aim of this study is assess the safety and efficacy of the treatment regimen of basiliximab cyclosporine microemulsion MMF and prednisone combined compared to cyclosporine microemulsion MMF and prednisone in the time to first biopsy proven acute rejection episode or treatment failure during the first 6 months post-transplantation in pediatric renal allograft 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