Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06589752
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-21
Brief Title:
Replication of the NefIgArd Trial of TRF-budesonide in Primary IgAN
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Replication of the NefIgArd Trial of Effectiveness and Safety of a Targeted-release Formulation of Budesonide in Patients With Primary IgA Nephropathy
Status:
COMPLETED
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:
This replication of the NefIgArd trial of TRF-budesonide aims to use real-world data to evaluate the efficiency and safety of TRF-budesonide in the treatment of IgA nephropathy from completing real-world research to providing real-world evidence
Detailed Description:
Currently TRF-budesonide are the first specific treatment for IgA nephropathy that targets intestinal mucosal immunity Results from part A of the Phase III clinical trial NCT03643965 show that compared to the placebo group the TRF-budesonide group significantly reduced proteinuria and hematuria stabilized renal function and lowered circulating Gd-IgA1 levels at 12 months However further real-world studies are needed to verify the efficiency and safety of this treatment for IgA nephropathy Therefore this replication trial of the part A of the Phase III clinical trial NefIgArd and evaluates the efficiency and safety of TRF-budesonide in treating IgA nephropathy based on existing observational data aiming to complete real-world research to provide real-world evidence that can guide clinical practice for IgA nephropathy 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