NCT07052981

Clinical Study on the Efficacy and Safety of Telitacicept in the Treatment of Pediatric IgA Nephropathy or IgA Vasculitis Nephritis

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Guixia Ding · Academic / Other
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Accepted

Summary

This clinical trial is a prospective, multicenter, non-randomized controlled study designed to evaluate the efficacy and safety of Telitacicept, a novel biologic agent, in treating pediatric IgA Nephropathy (IgAN) and IgA Vasculitis Nephritis (IgAVN). The study plans to enroll 124 children aged 5-18, divided into a test group (standard therapy + Telitacicept) and a control group (standard therapy alone), with a 24-week treatment period. The primary endpoint is the change in 24-hour urine protein levels at week 24, while secondary outcomes include UPCR (urine protein-to-creatinine ratio), eGFR, and drug safety.

Conditions

• IgA Nephropathy (IgAN)
• IgAVN

Interventions

Type	Name	Description
DRUG	Telitacicept	The study duration was 24 weeks, with the experimental group receiving subcutaneous injections of Telitacicept once weekly for a total of 24 weeks.

Timeline

• Start date: 2025-08-01
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2025-07-08
• Last updated: 2025-07-10