Finerenone Therapy for Pediatric HSPN With Mild Proteinuria

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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07315191

Acronym

FICHSPN

Enrollment

116

Registered

2026-01-02

Start date

2025-06-13

Completion date

2028-04-30

Last updated

2026-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Henoch Schönlein Purpura Nephritis

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.

Interventions

DRUGACEI / 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.

DRUGACEI/ARB

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Years to 18 Years

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;-

Design outcomes

Primary

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

Countries

China

Contacts

Primary ContactYue Jia

kamui1127@126.com86+13681366590

Backup ContactJuan Tu

86+13021049832

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026