NCT07315191

Finerenone Therapy for Pediatric HSPN With Mild Proteinuria

The Randomized Controlled Trial of Finerenone Therapy for Pediatric Hennoch Scholein Nephritis With Mild Proteinuria

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: Capital Institute of Pediatrics, China · Academic / Other
• Sex: All
• Age: 3 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

Henoch-Schönlein purpura nephritis (HSPN) is the most common secondary glomerular disease in children. About 40% of HSPN cases are accompanied by mild proteinuria, and some of them progress to end-stage renal disease. Currently, the treatment for children with mild proteinuria HSPN mainly involves ACEI/ARB, but long-term use of these drugs can lead to an increase in aldosterone levels, affecting therapeutic efficacy. Finerenone can improve vascular endothelial cell dysfunction and renal tissue inflammation and fibrosis, and reduce urinary protein in patients with glomerular diseases. This study intends to conduct an exploratory randomized controlled clinical trial of finerenone in children with HSPN accompanied by a small amount of proteinuria to evaluate the efficacy and safety of finerenone treatment.

Conditions

• Henoch Schönlein Purpura Nephritis

Interventions

Type	Name	Description
DRUG	ACEI / ARB+finerenone	In the finerenone group, finerenone was administered orally on the basis of combined oral ACEI/ARB, with the dose calculated based on body surface area, once a day for 3 months.
DRUG	ACEI/ARB	The control group was only given oral ACEI/ARB for 3 months.

Timeline

• Start date: 2025-06-13
• Primary completion: 2027-10-31
• Completion: 2028-04-30
• First posted: 2026-01-02
• Last updated: 2026-01-07

Locations

1 site across 1 country: China