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The Randomized Controlled Trial of Finerenone Therapy for Pediatric Hennoch Scholein Nephritis With Mild Proteinuria

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Capital Center for Children's Health,Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
Yue Jia
kamui1127@126.com
86+13681366590
Backup
Juan Tu
86+13021049832
Time Frame
Start Date: 2025-06-13
Estimated Completion Date: 2028-04-30
Participants
Target number of participants: 116
Treatments
Experimental: Finerenone group
Active_comparator: Control group
Sponsors
Leads: Capital Institute of Pediatrics, China

This content was sourced from clinicaltrials.gov