Finerenone Therapy for Pediatric HSPN With Mild Proteinuria

Sponsor
Capital Institute of Pediatrics, China
Study ID
NCT07315191
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Henoch Schönlein Purpura Nephritis

Eligibility Criteria

Sex
ALL
Age
3 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • ACEI / ARB+finerenone — DRUG
    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.
  • ACEI/ARB — DRUG
    The control group was only given oral ACEI/ARB for 3 months.

Study Details

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.

Key Dates

Start date
Jun 13, 2025
Status verified
Jan 2026
Primary completion
Oct 31, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
116 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Finerenone group
  • Active Comparator: Control group

Primary Outcome Measure

Percentage of Subjects with a Reduction in 24-Hour Urinary Protein Excretion ≥30% from Baseline [ Time Frame: 3 months ]

Central Contacts