Finerenone treatment for children with Henoch–Schönlein purpura nephritis and mild proteinuria

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

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
• Enrollment: 116 (estimated)
• Ages: 3 Years to 18 Years
• Sex: All
• Sponsor: Capital Institute of Pediatrics, China (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07315191 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Beijing, Beijing Municipality

• Capital Center for Children's Health,Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Yue Jia

Conditions Henoch Schönlein Purpura Nephritis