Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00425438
Status:
TERMINATED
Last Update Posted:
2014-09-25
First Post:
2007-01-22
Brief Title:
A Study of CellCept Mycophenolate Mofetil in Patients With Lupus Nephritis
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Randomized Open-label Study to Compare the Effect of CellCept Plus Corticosteroids and Cyclophosphamide Plus Corticosteroids Followed by Azathioprine on Remission Rate in Patients With Lupus Nephritis
Status:
TERMINATED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was terminated early for administrative reasons
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 will compare the efficacy and safety of CellCept plus corticosteroids versus cyclophosphamide plus corticosteroids in the induction phase followed by azathioprine in the maintenance phase in maintaining remission and renal function in patients with lupus nephritis Patients will be randomized to receive CellCept 1g bid po plus corticosteroids for 24 weeks followed by CellCept 075g bid po plus corticosteroids for the following 24 weeks or cyclophosphamide 05-10gm2 monthly plus corticosteroids for 24 weeks followed by azathioprine 2mgkgday po plus corticosteroids for the following 24 weeks Response rate will be assessed at the end of the induction phase and at the end of study The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals
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