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

Launched by GUIXIA DING · Jun 30, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medicine called Telitacicept to see if it helps children with two kidney conditions: IgA Nephropathy (IgAN) and IgA Vasculitis Nephritis (IgAVN). These conditions cause protein to leak into the urine, which can harm the kidneys over time. The study will include about 124 children between the ages of 5 and 18 who have moderate to heavy protein in their urine and healthy enough kidney function. Participants will either receive the usual treatment plus Telitacicept or the usual treatment alone, and the study will last about 24 weeks (roughly six months).

If your child joins the study, doctors will monitor their urine protein levels and kidney function to see how well Telitacicept works and to check for any side effects. Children with infections, severe health problems, or certain other medical conditions won’t be able to participate to keep everyone safe. This trial is not yet recruiting, but it aims to find better ways to treat these kidney diseases in children and improve their long-term health.

Gender

ALL

Eligibility criteria

• 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.