The Randomized Controlled Trial of Finerenone Therapy for Pediatric Hennoch Scholein Nephritis With Mild Proteinuria
Overview
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Capital Institute of Pediatrics, China
- Enrollment
- 116
- Locations
- 1
- Primary Endpoint
- Percentage of Subjects with a Reduction in 24-Hour Urinary Protein Excretion ≥30% from Baseline
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 3 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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);
- •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;-
Arms & Interventions
Finerenone group
Intervention: ACEI / ARB+finerenone (Drug)
Control group
Intervention: ACEI/ARB (Drug)
Outcomes
Primary Outcomes
Percentage of Subjects with a Reduction in 24-Hour Urinary Protein Excretion ≥30% from Baseline
Time Frame: 3 months
Secondary Outcomes
No secondary outcomes reported