Clinical Trial

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

Not Yet Recruiting Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-06-30.
Trial Details
NCT Number NCT07052981
Lead Sponsor Guixia Ding
Conditions IgA Nephropathy (IgAN), IgAVN
Enrollment 124 participants
Start Date 2025-08-01
Primary Completion 2027-06-30 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-07-10