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Clinical Trials in China / NCT07315191
Recruiting Phase 4

Finerenone Therapy for Pediatric HSPN With Mild Proteinuria

NCT07315191 · tracked via the Priya Life Science China tracker
Sponsor
Capital Institute of Pediatrics, China
Phase
Phase 4
Started
2025-06-13
Last updated
2026-01-07

Condition(s) studied

Henoch Schönlein Purpura Nephritis

Investigational drug(s) / intervention(s)

ACEI / ARB+finerenone →ACEI/ARB

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.

ACEI/ARB: The control group was only given oral ACEI/ARB for 3 months.

Study 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

Sex
ALL
Min age
3 Years
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: 1. Children of HSPN meet the following conditions① Age \> 3 years old and \< 18 years old; 2. 24-hour urine protein quantification \>= 8mg/h/M2 body surface area (or \>= 300mg/d), and \< 20mg/h/M2 body surface area (\< 1000mg/d); 3: 3. Sign the informed consent form. Exclusion Criteria: 1. Abnormal renal function: eGFR \< 90 ml/min/1.73m\^2 body surface area; 2. Renal pathological grade \>= IV; 3. Application of glucocorticoids and/or immunosuppressants within 2 weeks; 4. Recent applications involving high-dose glucocorticoids administered for a duration exceeding two weeks.; 5. Liver transaminase \> 2 times the upper limit of normal; 6. Severe cardiac insufficiency; 7. Simultaneous use of CYPA4 inhibitors;-

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Capital Center for Children's Health,Capital Medical University Beijing Beijing Municipality Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07315191 on ClinicalTrials.gov ↗ ← All trials in China