Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00377637
Status:
COMPLETED
Last Update Posted:
2011-12-06
First Post:
2006-09-15
Brief Title:
A Study of Mycophenolate Mofetil CellCept in Management of Patients With Lupus Nephritis
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Prospective Randomized Active Controlled Parallel Group Multi-center Trial to Assess the Efficacy and Safety of Mycophenolate Mofetil MMF in Inducing Response and Maintaining Remission in Subjects With Lupus Nephritis
Status:
COMPLETED
Status Verified Date:
2011-10
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:
This 2 arm study assessed the efficacy of Mycophenolate Mofetil MMF CellCept compared to cyclophosphamide in inducing a response in patients with lupus nephritis and the long term efficacy of MMF compared to azathioprine in maintaining remission and renal function Patients were randomized to receive either MMF 15 g twice daily bid or cyclophosphamide 05-10 gm2 in monthly pulses in the induction phase Those patients meeting criteria for response were re-randomized for entry into the maintenance phase to receive either MMF 1 g bid or azathioprine 2 mgkgday
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