Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00301652
Status:
COMPLETED
Last Update Posted:
2010-06-08
First Post:
2006-03-10
Brief Title:
MMF Versus CTX in the Induction Treatment of ANCA Associated Vasculitis
Sponsor:
Nanjing University School of Medicine
Organization:
Nanjing University School of Medicine
Study Overview
Official Title:
Mycophenolate Mofetil Versus Cyclophosphamide in the Induction Treatment of ANCA Associated Vasculitis
Status:
COMPLETED
Status Verified Date:
2009-03
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:
The purpose of this study is to access the efficacy of MMF compared to CTX in inducing remission and improving renal function in subjects with ANCA associated vasculitis with renal involvement
Detailed Description:
The ANCA-associated vasculitides can be life threatening Glucocorticoids and cyclophosphamide therapy is effective in about 80 patients However the side effects such as bone marrow suppression infection cystitis infertility myelodysplasia preclude further use of cyclophosphamide in some patients and the relapse rate is high
Recent studies have shown that mycophenolic acidMPA the active metabolite of mycophenolate mofetilMMF could exhibit multifarious effects on endothelial cells including inhibition of ICAM-1 expression neutrophil attachmentIL-6 secretion and the process of angiogenesis which contribute to the efficacy of MMF in the treatment of vasculitic lesions such as lupus nephritis with vasculitic lesions This study was a feasibility study to assess the safety and effectiveness of MMF in inducing remission in subjects with ANCA-associated SVV compared with pulse intravenous cyclophosphamide After enrollment subjects were followed longitudinally and formal measurements of disease activity were determined using the Birmingham Vasculitis Activity Score BVAS
Recent studies have shown that mycophenolic acidMPA the active metabolite of mycophenolate mofetilMMF could exhibit multifarious effects on endothelial cells including inhibition of ICAM-1 expression neutrophil attachmentIL-6 secretion and the process of angiogenesis which contribute to the efficacy of MMF in the treatment of vasculitic lesions such as lupus nephritis with vasculitic lesions This study was a feasibility study to assess the safety and effectiveness of MMF in inducing remission in subjects with ANCA-associated SVV compared with pulse intravenous cyclophosphamide After enrollment subjects were followed longitudinally and formal measurements of disease activity were determined using the Birmingham Vasculitis Activity Score BVAS
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