Finerenone Therapy for Pediatric HSPN With Mild Proteinuria
The Randomized Controlled Trial of Finerenone Therapy for Pediatric Hennoch Scholein Nephritis With Mild Proteinuria
Capital Institute of Pediatrics, China
116 participants
Jun 13, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- Children of HSPN meet the following conditions① Age > 3 years old and < 18 years old;
- 24-hour urine protein quantification >= 8mg/h/M2 body surface area (or >= 300mg/d), and < 20mg/h/M2 body surface area (< 1000mg/d);
- : 3. Sign the informed consent form.
Exclusion Criteria7
- Abnormal renal function: eGFR < 90 ml/min/1.73m\^2 body surface area;
- Renal pathological grade >= IV;
- Application of glucocorticoids and/or immunosuppressants within 2 weeks;
- Recent applications involving high-dose glucocorticoids administered for a duration exceeding two weeks.;
- Liver transaminase > 2 times the upper limit of normal;
- Severe cardiac insufficiency;
- Simultaneous use of CYPA4 inhibitors;-
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Interventions
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.
The control group was only given oral ACEI/ARB for 3 months.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07315191