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

Sponsor
Guixia Ding
Study ID
NCT07052981
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • IgA Nephropathy (IgAN)
  • IgAVN

Eligibility Criteria

Sex
ALL
Age
5 Years - 18 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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 Dates

Start date
Aug 1, 2025
Status verified
Jul 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
124 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental group
    The intervention measure for the experimental group is the administration of Telitacicept in addition to standard treatment
  • No Intervention: control group
    The intervention measure for the control group is standard treatment (corticosteroids with or without other immunosuppressants) for 24 weeks.

Primary Outcome Measure

24-hour urinary protein [ Time Frame: At each follow-up visit(0、4、8、12、16、20、24week) ]

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