Finerenone Therapy for Pediatric HSPN With Mild Proteinuria

ConditionHenoch Schönlein Purpura Nephritis

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age3-18

SponsorCapital Institute of Pediatrics, China

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

24-hour urine protein quantification >= 8mg/h/M2 body surface area (or >= 300mg/d), and < 20mg/h/M2 body surface area (< 1000mg/d);

Disqualifiers

Abnormal renal function: eGFR < 90 ml/min/1.73m² 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.;

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

116 Participants

are divided into 2 treatment groups

Group A: Finerenone groupExperimental treatment 1 intervention

Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

3 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Capital Institute of Pediatrics, China

Lead sponsor

Source ClinicalTrials.gov

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