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

NCT07052981 | Not Yet Recruiting Phase 3

• 1 other identifier: 202504040-2
• Study Type: interventional
• Target: 124
• Locations: 0 countries
• Sites: N/A

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.

Conditions

IgA Nephropathy (IgAN); IgAVN

Outcome Measures

Primary Outcomes (1)

• 24-hour urinary protein

  At each follow-up visit(0、4、8、12、16、20、24week)

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Drug: Telitacicept

control group

NO INTERVENTION

The intervention measure for the control group is standard treatment (corticosteroids with or without other immunosuppressants) for 24 weeks.

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.

Experimental group

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guixia Ding: lead

MeSH Terms

Conditions

Glomerulonephritis, IGA

Interventions

telitacicept

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 8, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 10, 2025

Record last verified: 2025-07