Ignite Creation Date:
2024-05-06 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05799287
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-06
First Post:
2023-03-05
Brief Title:
A Study of Telitacicept in Patients with Primary Immunoglobulin AIgA Nephropathy
Sponsor:
RemeGen Co Ltd
Organization:
RemeGen Co Ltd
Study Overview
Official Title:
A Phase III Multicenter Randomized Double-blind Placebo-controlled Trial to Evaluate the Efficacy and Safety of Telitacicept in Patients with Primary IgA Nephropathy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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 evaluate the efficacy and safety of Telitacicept in patients with primary IgA nephropathy at risk of progressing to end-stage renal diseaseESRD despite maximum tolerated treatment with renin-angiotensin systemRAS blockade using angiotensin converting enzyme inhibitors ACEIs or angiotensin II type I receptor blockers ARBs
Detailed Description:
This study consists of a 5-week screening period a double-blind treatment period divided into phase A and phase B Eligible subjects will be randomly assigned in a 11 ratio to receive either Telitacicept 240mg or placebo Subjects will be given subcutaneous injectionSC Telitacicept or placebo once a week for a total of 39 doses in phase A and once every 2 weeks for a total of 32 doses in phase B
Primary endpoint of phase A will be measured at week 39 Primary endpoint of phase B will be measured at week 104
Primary endpoint of phase A will be measured at week 39 Primary endpoint of phase B will be measured at week 104
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None