Finerenone Therapy for Pediatric HSPN With Mild Proteinuria (FICHSPN)

Capital Institute of Pediatrics, China

Status and phase: Enrolling; Phase 4

Conditions: Henoch Schönlein Purpura Nephritis

Treatments: Drug: ACEI/ARB; Drug: ACEI / ARB+finerenone

Study type: Interventional

Funder types: Other

Identifiers

NCT07315191

BRWEP2024W102100109

Details and patient eligibility

About

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.

Enrollment: 116 estimated patients

Sex: All

Ages: 3 to 18 years old

Volunteers: No Healthy Volunteers

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;-

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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116 participants in 2 patient groups

Finerenone group

Experimental group

Treatment:

Drug: ACEI / ARB+finerenone

Control group

Active Comparator group

Treatment:

Drug: ACEI/ARB