Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06654596
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-18
Brief Title:
Efficacy and Safety of Telitacicept in IgAN
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Randomized Controlled Clinical Study on the Efficacy and Safety of Telitacicept in Patients with IgA Nephropathy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
A study to evaluate efficacy and safety of telitacicept in the treatment of patients with primary IgA nephropathy at high risk of progression
Detailed Description:
IgA nephropathy is a glomerulonephritis characterized by pathological IgA deposition in the mesangial region Its clinical and pathological manifestations are diverse and heterogeneous Its pathogenesis has not yet been fully clarified and there is currently no unified treatment plan As a recombinant human B lymphocyte stimulator receptor-antibody fusion protein telitacicept has become a new therapeutic target The results of the Phase II clinical trial of this drug for IgA nephropathy have already been published It is one of the key pioneering clinical studies in the field of IgA nephropathy treatment The study showed that telitacicept can effectively reduce patients proteinuria and reduce the risk of disease progression Based on the above research results the investigators plan to conduct a multicenter randomized controlled clinical study to evaluate the efficacy and safety of telitacicept in the treatment of primary IgA nephropathy patients with a high risk of progression
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