Finerenone Therapy for Pediatric HSPN With Mild Proteinuria (FICHSPN)

January 5, 2026 updated by: Capital Institute of Pediatrics, China

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

116

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Juan Tu
  • Phone Number: 86+13021049832

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100020
        • Recruiting
        • Capital Center for Children's Health,Capital Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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;-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
Drug: ACEI/ARB
The control group was only given oral ACEI/ARB for 3 months.
Experimental: Finerenone group
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Subjects with a Reduction in 24-Hour Urinary Protein Excretion ≥30% from Baseline
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Capital Institute of Pediatrics, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2025

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

April 30, 2028

Study Registration Dates

First Submitted

December 18, 2025

First Submitted That Met QC Criteria

December 18, 2025

First Posted (Estimated)

January 2, 2026

Study Record Updates

Last Update Posted (Actual)

January 7, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRWEP2024W102100109

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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