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

Not Applicable

Not yet recruiting

• Conditions: IgA Nephropathy (IgAN); IgAVN
• Interventions: Drug: Telitacicept

• Registration Number: NCT07052981
• Lead Sponsor: Guixia Ding

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-06-30
• Study First Submitted QC: 2025-06-30
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-07
• Study First Posted: 2025-07-08
• Last Update Posted: 2025-07-10
• Study Start: 2025-08-01
• Primary Completion: 2027-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

• Diagnosed with IgA nephropathy (IgAN) or IgA vasculitis nephritis (IgAVN) Aged 5 to 18 years Weight ≥25 kg Moderate or heavy proteinuria At enrollment, estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73m² calculated using the Schwartz formula (36.5 × height [cm] / serum creatinine [μmol/L]).

Willing to sign the informed consent form

Exclusion Criteria

• There is an ongoing infection that requires antiviral drugs or antibiotics for treatment.

The patient has received other B cell-targeting biologics within the three months prior to enrollment.

Patients with uncontrolled severe hypertension or diabetes. Individuals with other autoimmune diseases, primary immunodeficiencies, or tumors.

A history of organ transplantation. Patients with chronic active infections, such as Epstein-Barr virus, cytomegalovirus, or Mycobacterium tuberculosis, whose disease state may be exacerbated by the use of steroids and immunosuppressive agents.

Patients with severe liver failure, heart failure, or end-stage renal disease (ESRD).

Any other medical conditions that may place the patient at increased risk by participating in this study.

Individuals deemed by the investigator as unsuitable for participation in this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Telitacicept	The intervention measure for the experimental group is the administration of Telitacicept in addition to standard treatment

Primary Outcome Measures

Name	Time	Method
24-hour urinary protein	At each follow-up visit(0、4、8、12、16、20、24week)