Finerenone Therapy for Pediatric HSPN With Mild Proteinuria
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ACEI / ARB+finerenone, ACEI/ARB.
- Who it may be relevant to
- Registry conditions: Henoch Schönlein Purpura Nephritis. Basic parameters: 3 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Randomized Controlled Trial of Finerenone Therapy for Pediatric Hennoch Scholein Nephritis With Mild Proteinuria
Overview
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
- 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. - Drug ACEI/ARB
The control group was only given oral ACEI/ARB for 3 months.
Primary outcome measures
- Percentage of Subjects with a Reduction in 24-Hour Urinary Protein Excretion ≥30% from Baseline [Time frame: 3 months]
Eligibility criteria
Inclusion criteria
- 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);
3: 3. Sign the informed consent form.
Exclusion criteria
- 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;-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Capital Center for Children's Health,Capital Medical University — Beijing
Identifiers
NCT: NCT07315191 · BRWEP2024W102100109