Finerenone treatment for children with Henoch–Schönlein purpura nephritis and mild proteinuria
Official title: The Randomized Controlled Trial of Finerenone Therapy for Pediatric Hennoch Scholein Nephritis With Mild Proteinuria
Run by Capital Institute of Pediatrics, China · NCT07315191 · Data updated 2026-11-12
This trial will test whether adding finerenone to standard ACEI/ARB therapy helps reduce protein in the urine and is safe for children aged 3 to 17 with HSPN and mild proteinuria.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 3 Years to 18 Years |
| Sex | All |
| Enrollment | 116 (estimated) |
| Sponsor | Capital Institute of Pediatrics, China Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | June 13, 2025 |
| Main results expected | October 31, 2027 |
| Study ends | April 30, 2028 |
| Registry record updated | January 7, 2026 |
| Trial ID | NCT07315191 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged >3 to <18 with HSPN who have mild proteinuria within the trial's specified range, preserved kidney function (eGFR ≥90 ml/min/1.73 m²), and who can receive ACEI/ARB therapy.
✕Probably not a fit
Children with reduced kidney function (eGFR <90), advanced renal pathology (grade ≥IV), heavy proteinuria, recent or ongoing immunosuppressive treatment, significant liver or heart disease, or who are taking CYP3A4 inhibitors are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, exploratory Phase 4 trial comparing ACEI/ARB plus finerenone versus ACEI/ARB alone in children with Henoch–Schönlein purpura nephritis who have mild proteinuria. Participants aged over 3 and under 18 with defined low-range proteinuria and preserved kidney function will be enrolled and randomized to receive the combination or standard therapy. The study will monitor urine protein levels and safety measures, including kidney and liver function and adverse events. Patients with reduced eGFR, high pathological grade disease, recent immunosuppression, or certain drug interactions are excluded to focus on a stable, mild-proteinuria population.
Why it matters
Potential benefit: If successful, adding finerenone could reduce urinary protein and potentially slow kidney damage in children with HSPN while remaining safe.
How similar studies have gone: Finerenone has shown reduced proteinuria and renal benefits in adult chronic kidney disease trials, but its use in pediatric HSPN is largely untested and exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
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;-
Where it's running
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Capital Center for Children's Health,Capital Medical University
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Yue Jia
- Email: kamui1127@126.com
- Phone: 86+13681366590
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.