Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00239031
Status:
COMPLETED
Last Update Posted:
2011-01-31
First Post:
2005-10-12
Brief Title:
Study of Enteric-Coated Mycophenolate Sodium EC-MPS Plus Reduced-dose Cyclosporine Microemulsion CsA-ME Compared to EC-MPS Plus Standard Dose CsA-ME in Eldery de Novo Renal Transplant Recipients Treated With Basiliximab and Short-term Steroids
Sponsor:
Novartis
Organization:
Novartis
Study Overview
Official Title:
Multicentre Controlled Prospective Randomized Open-label Clinical Trial to Compare Enteric-Coated Mycophenolate Sodium EC-MPS Plus Reduced Dose Cyclosporine Microemulsion CsA-ME Vs EC-MPS Plus Standard Dose CsA-ME in Elderly de Novo Renal Transplant Recipients Treated With Basiliximab and Short-term Steroids
Status:
COMPLETED
Status Verified Date:
2011-01
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:
All patients of the core study who are interested of being treated with EC-MPS will be included in an open-label extension study to collect further information on the long-term safety tolerability and efficacy of this drug
The aim of this study is to compare the renal function 6 months after transplant in de novo old-age renal transplant recipients treated with EC-MPS plus reduced dose CsA-ME or with EC-MPS plus standard dose CsA-ME both in combination with basiliximab and short-term oral steroids
The aim of this study is to compare the renal function 6 months after transplant in de novo old-age renal transplant recipients treated with EC-MPS plus reduced dose CsA-ME or with EC-MPS plus standard dose CsA-ME both in combination with basiliximab and short-term oral steroids
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