Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00229138
Status:
COMPLETED
Last Update Posted:
2017-02-07
First Post:
2005-09-27
Brief Title:
Efficacy and Safety of Enteric-Coated Mycophenolate Sodium EC-MPS in Kidney Transplant Recipients
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Six-month Prospective Multicenter Open Label Parallel Randomized Study of the Safety Tolerability and Efficacy of EC-MPS With Basiliximab Corticosteroids and Two Different Levels of Tacrolimus in de Novo Renal Transplant Recipients
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will investigate the safety tolerability and efficacy of EC-MPS with tacrolimus at both reference and reduced levels This study will take into account safety aspects such as decreased renal toxicity by reducing the overall exposure to tacrolimus
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