Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00154310
Status:
COMPLETED
Last Update Posted:
2013-11-13
First Post:
2005-09-08
Brief Title:
Efficacy and Safety of Everolimus With Enteric-Coated Mycophenolate Sodium EC-MPS in a Cyclosporine Microemulsion-free Regimen Compared to Standard Therapy in de Novo Renal Transplant Patients
Sponsor:
Novartis
Organization:
Novartis
Study Overview
Official Title:
Multi-center Open-label Prospective Randomized Parallel Group Study Investigating a CNI-free Regimen With Enteric-Coated Mycophenolate Sodium EC-MPS and Everolimus in Comparison to Standard Therapy With Enteric-Coated Mycophenolate Sodium EC-MPS and Cyclosporine Microemulsion in de Novo Renal Transplant Patients
Status:
COMPLETED
Status Verified Date:
2013-10
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 purpose of this study is to assess whether a calcineurin inhibitor CNI-free regimen with enteric-coated mycophenolate sodium EC-MPS and everolimus is as safe and well-tolerated as the standard regimen containing enteric-coated mycophenolate sodium EC-MPS and cyclosporine microemulsion but results in better renal function
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