Finerenone Therapy for Pediatric HSPN With Mild Proteinuria

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-13

Study Completion Date

2028-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Henoch Schönlein Purpura Nephritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Finerenone group

Group Type EXPERIMENTAL

ACEI / ARB+finerenone

Intervention Type 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.

Control group

Group Type ACTIVE_COMPARATOR

ACEI/ARB

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

ACEI/ARB

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

Intervention Type DRUG

Eligibility Criteria

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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;-

Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No