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Finerenone Therapy for Pediatric HSPN With Mild Proteinuria

RecruitingPhase 4Ages 3 Years - 18 YearsAllCapital Institute of Pediatrics, China
NCT07315191 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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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📋 Eligibility rules (as published)
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;-
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What it tests

  • ACEI / ARB+finerenone
  • ACEI/ARB
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Where

1 site
Capital Center for Children's Health,Capital Medical University
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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