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NOT YET RECRUITING
NCT07052981
PHASE3

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

Sponsor: Guixia Ding

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.

Key Details

Gender

All

Age Range

5 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

124

Start Date

2025-08-01

Completion Date

2027-06-30

Last Updated

2025-07-10

Healthy Volunteers

Yes

Interventions

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.