Capital Center for Children's Health,Capital Medical University
Beijing, Beijing Municipality, 100020, China
Location status: Recruiting
Recruiting
NCT Number: NCT07315191
Finerenone Therapy for Pediatric HSPN With Mild Proteinuria
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
3 year–18 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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;-
Treatment and study plan
ACEI / ARB+finerenone
DrugIn 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
DrugThe control group was only given oral ACEI/ARB for 3 months.
Primary outcomes
-
Percentage of Subjects with a Reduction in 24-Hour Urinary Protein Excretion ≥30% from Baseline
Time frame: 3 months
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Capital Institute of Pediatrics, China
Other
Registry information
Official study title
The Randomized Controlled Trial of Finerenone Therapy for Pediatric Hennoch Scholein Nephritis With Mild Proteinuria
Acronym: FICHSPN
Important dates
- Study start
- 2025
- Primary completion
- 2027
- Study completion
- 2028
- First posted
- Jan 2, 2026
- Registry last updated
- Jan 7, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.