Finerenone Therapy for Pediatric HSPN With Mild Proteinuria

NCT07315191 | Recruiting Phase 4

• 1 other identifier: BRWEP2024W102100109
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Henoch Schönlein Purpura Nephritis

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects with a Reduction in 24-Hour Urinary Protein Excretion ≥30% from Baseline

  3 months

Study Arms (2)

Finerenone group

EXPERIMENTAL

Drug: ACEI / ARB+finerenone

Control group

ACTIVE COMPARATOR

Drug: ACEI/ARB

Interventions

ACEI / ARB+finerenone DRUG

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.

Finerenone group

ACEI/ARB DRUG

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

Control group

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children of HSPN meet the following conditions① Age \> 3 years old and \< 18 years old;
• 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.

You may not qualify if:

• 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;-

Sponsors & Collaborators

• Capital Institute of Pediatrics, China: lead

Study Sites (1)

Capital Center for Children's Health,Capital Medical University

Beijing, Beijing Municipality, 100020, China

RECRUITING

MeSH Terms

Interventions

Angiotensin-Converting Enzyme Inhibitors

Intervention Hierarchy (Ancestors)

Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Yue Jia

CONTACT

86+13681366590; kamui1127@126.com

Juan Tu

CONTACT

86+13021049832

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 2, 2026
• Study Start: June 13, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

CN (1)