Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06607016
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
A Clinical Trial with KJ103 in Anti-GBM Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-Label Single-Arm Phase II Clinical Trial to Evaluate the Initial Efficacy Safety Pharmacokinetics Pharmacodynamics and Immunogenicity of KJ103 for the Treatment of Patients with Anti-Glomerular Basement Membrane Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
An open-label single-arm Phase II study to evaluate the preliminary efficacy safety pharmacokinetics pharmacodynamics and immunogenicity of KJ103 in patients with anti-GBM disease
Detailed Description:
Anti-glomerular basement membrane GBM disease is a severe rare autoimmune disorder with an internationally reported incidence of 05-11 million It is defined as a vasculitis in which anti-GBM antibodies affect glomerular capillaries pulmonary capillaries or both Pulmonary involvement leads to pulmonary haemorrhage and renal involvement can lead to glomerulonephritis with necrosis and crescents
Anti-GBM disease is a severe autoimmune disorder characterised by rapidly progressive glomerulonephritis and positive anti-GBM antibodies Antibodies can be found in the circulation and deposited in the lungs and kidneys mediating renal injury through complement activation and recruitment of inflammatory cells If left untreated the vast majority of patients will progress to end-stage renal disease ESRD or die from pulmonary haemorrhage Early detection and measures to reduce anti-GBM antibody levels have the potential to alter prognosis and protect renal function Unfortunately many patients with anti-GBM disease are diagnosed late and renal function is not restored even with an aggressive treatment regimen of plasma exchange PE combined with immunosuppression Current KDIGO Kidney Disease Improving Global Prognosis Organisation guidelines state that the clinical treatment of anti-GBM disease is a combination of glucocorticoids cyclophosphamide and PE Despite treatment patients continue to produce anti-GBM antibodies in their bodies Rebound anti-GBM antibodies are usually indicative of adverse renal outcomes and PE must be initiated to remove the rebound antibodiesPE is an effective means of removing circulating anti-GBM antibodies but only removes about 13 of the percentage per treatment so multiple treatments are required to achieve complete removal
This is a single-arm Phase II study designed to evaluate the preliminary efficacy safety pharmacokinetics pharmacodynamics and immunogenicity of KJ103 in patients with anti-GBM disease The trial is expected to enrol 9 to 12 subjects who will receive KJ103 treatment
Anti-GBM disease is a severe autoimmune disorder characterised by rapidly progressive glomerulonephritis and positive anti-GBM antibodies Antibodies can be found in the circulation and deposited in the lungs and kidneys mediating renal injury through complement activation and recruitment of inflammatory cells If left untreated the vast majority of patients will progress to end-stage renal disease ESRD or die from pulmonary haemorrhage Early detection and measures to reduce anti-GBM antibody levels have the potential to alter prognosis and protect renal function Unfortunately many patients with anti-GBM disease are diagnosed late and renal function is not restored even with an aggressive treatment regimen of plasma exchange PE combined with immunosuppression Current KDIGO Kidney Disease Improving Global Prognosis Organisation guidelines state that the clinical treatment of anti-GBM disease is a combination of glucocorticoids cyclophosphamide and PE Despite treatment patients continue to produce anti-GBM antibodies in their bodies Rebound anti-GBM antibodies are usually indicative of adverse renal outcomes and PE must be initiated to remove the rebound antibodiesPE is an effective means of removing circulating anti-GBM antibodies but only removes about 13 of the percentage per treatment so multiple treatments are required to achieve complete removal
This is a single-arm Phase II study designed to evaluate the preliminary efficacy safety pharmacokinetics pharmacodynamics and immunogenicity of KJ103 in patients with anti-GBM disease The trial is expected to enrol 9 to 12 subjects who will receive KJ103 treatment
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