Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00268567
Status:
COMPLETED
Last Update Posted:
2005-12-22
First Post:
2005-12-21
Brief Title:
Induction Treatment of Proliferative Lupus Nephritis With Leflunomide Combined With Prednisone
Sponsor:
Peking University
Organization:
Peking University
Study Overview
Official Title:
Phase 3 Study of Leflunomide Combined With Prednisone Treatment of Proliferative Lupus Nephritis as Induction Therapy
Status:
COMPLETED
Status Verified Date:
2004-10
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:
lupus nephritis accounts for the most morbidity and mortality in patients with SLE Glucocorticoids combined with cyclophosphamide CYC are effective for the treatment of patients with proliferative lupus nephritis and have been the immunosuppressive regimen of choice for many years However some patients do not respond well to the regimen and adverse effects of cyclophosphamide limit its use in certain patients Leflunomide is a novel immunosuppressive agent currently used in the treatment of rheumatoid arthritisThere were a few pilot observational studies and reports suggesting leflunomide was also safe well-tolerated and may be effective in SLE patients without important organ involvement It has not been shown if leflunomide can be used in the treatment of patients with lupus nephritis We therefore undertook a multi-center controlled study to investigate the efficacy and safety profile of leflunomide compared with cyclophosphamide in the treatment of patients with biopsy proven proliferative lupus nephritis
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