NCT07030894

Nefecon and Ambrisentan in IgA Nephropathy

A Prospective, Single-Arm Clinical Study of Budesonide in Combination With Ambrisentan for the Treatment of Patients With IgA Nephropathy

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 129 (estimated)
• Sponsor: The First Hospital of Jilin University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• IgA Nephropathy
• Chronic Kidney Disease
• Proteinuria

Interventions

Type	Name	Description
DRUG	"Nefecon®","Ambrisentan"	Subjects who meet the screening criteria will be treated with Budesonide in combination with Ambrisentan. Budesonide (Nefecon®), 16mg/d for 36 weeks, taken orally. Ambrisentan , 5mg/d for 36 weeks, taken orally.

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-06-22
• Last updated: 2025-09-15

Locations

1 site across 1 country: China