Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00369278
Status:
COMPLETED
Last Update Posted:
2011-03-29
First Post:
2006-08-25
Brief Title:
Intensified vs Standard Dose Therapy With Mycophenolate Sodium Plus Cyclosporin Microemulsion and Corticosteroid Combination in Patients With de Novo Renal Transplant Patients
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
Multi-center Open-label Prospective Randomized Parallel Group Study Investigating an Intensified Enteric-coated Mycophenolate Sodium EC-MPS Dosing Regimen in Comparison to a Standard Dosing Regimen of EC-MPS in Combination With Cyclosporin Microemulsion and Corticosteroids in de Novo Renal Transplant Patients
Status:
COMPLETED
Status Verified Date:
2011-03
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 study will assess the association of an initially intensified dosing regimen of enteric-coated mycophenolate sodium EC-MPS during the first 6 weeks post renal transplantation with acute rejections relative to the rapid achievement of an MPA mycophenolic acid exposure of 40 mghL compared to a standard dosing regimen of EC-MPS Additionally this study will assess safety and tolerability of the intensified dosing regimen of EC-MPS This study will be conducted in 2 stages Stage I and Stage II
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