Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-26 @ 1:52 AM
Study NCT ID:
NCT07030894
Status:
RECRUITING
Last Update Posted:
2025-09-15
First Post:
2025-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nefecon and Ambrisentan in IgA Nephropathy
Sponsor:
The First Hospital of Jilin University
Organization:
Study Overview
Official Title:
A Prospective, Single-Arm Clinical Study of Budesonide in Combination With Ambrisentan for the Treatment of Patients With IgA Nephropathy
Status:
RECRUITING
Status Verified Date:
2025-08
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:
BAIN
Brief Summary:
Application of Budesonide in Combination with Ambrisentan in the treatment of IgA nephropathy with progression ESKD risk (24-hour urinary protein ≥ 0.5g/24h), observing the degree and safety of reducing urinary protein and delaying eGFR progression, and observing changes in serum Gd-IgA1 levels
Detailed Description:
This study is a prospective, single arm clinical trial planned to recruit 129 patients with primary IgA nephropathy. Including a screening period and a treatment period, a total of 6 visits were conducted. The screening period was completed within 30 days before the treatment period, and the medical history, medication, and examination results collected during the visits were used as the basis for screening subjects in this study. Subjects who met the inclusion criteria but did not meet any exclusion criteria were enrolled in the study and treated with Budesonide in combination with Ambrisentan for a total of 36 weeks. After the end of the trial, data from 129 enrolled patients were analyzed for statistical analysis. If the treatment is effective, randomized controlled trials will be added to validate it when conditions permit.
Study Oversight
Has Oversight DMC:
False
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?: