Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06513338
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Complement C5 mAb in the Treatment of Anti-GBM Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single Center Open-label Single Arm Phase II Trial of the Efficacy and Safety of Complement C5 Monoclonal Antibody in the Treatment of Anti-glomerular Basement Membrane Disease
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Anti-GBM disease is the most severe form of glomerulonephritis Despite of the standard treatment including plasmapheresis and immunosuppressant 70 of the patients still go into end-stage kidney disease Complement has been shown to participate in the pathogenesis of anti-GBM disease This study aims to the investigate the therapeutic effects and safety of C5 monoclonal antibody in the treatment of anti-GBM disease
Detailed Description:
Anti-glomerular basement membrane anti-GBM disease is the most severe form of autoimmune glomerulonephritis characterized by the production of autoantibodies targeting the components of basement membrane within the kidney andor the lungPatients with anti-GBM disease typically present rapidly progressive glomerulonephritis and often accompanied by lung hemorrhage The hallmark of the disease is the linear deposition of IgG along the GBM on kidney biopsy Complement activation is a pivotal step for kidney injuries during the development of human anti-GBM disease Our previous study showed that the The levels of plasma SC5b-9 and urinary C5a were positively correlated with the serum creatinine at presentation and the percentage of crescents in glomeruli Eculizumab is a recombinant humanized monoclonal antibody that specifically binds to a C5 terminal complement and inhibits the cleavage of C5 to C5a and C5b through complement activation There are a few case reports showing therapeutic effects in anti-GBM disease This trial will aim to evaluate the efficacy and safety of Eculizumab plus standard treatment in anti-GBM disease
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