Telitacicept in the Treatment of Pediatric IgA Vasculitis-Associated Nephritis (NCT07354503) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Telitacicept in the Treatment of Pediatric IgA Vasculitis-Associated Nephritis
300 participantsStarted 2026-01-01
Plain-language summary
To further evaluate the efficacy and safety of Telitacicept in the treatment of pediatric IgA vasculitis nephritis (IgAVN) within real-world settings, this study employs a multicenter, retrospective and prospective observational research design. It aims to compare the efficacy of Telitacicept with that of glucocorticoids, thereby providing clinicians with a reference for the rational and standardized application of Telitacicept.
Who can participate
Age range3 Years – 17 Years
SexALL
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Inclusion criteria
✓. Age 3-17 years;
✓. Patients diagnosed with IgA vasculitis nephritis (IgAVN) based on clinical manifestations and renal pathological diagnosis;
✓. Urinary protein quantification requirements: urinary protein/creatinine ratio (UPCR) of ≥1 mg/mg (100 mg/mmol);
✓. Estimated glomerular filtration rate (eGFR) calculated using the modified Schwartz formula of ≥60 mL/min/1.73 m².
✓. Renal biopsy is optional (if a renal biopsy is performed, cases classified as International Society of Nephropathology (ISKDC) grade ≥IV must be excluded).
Exclusion criteria
✕. Patients with congenital or acquired immunodeficiency, or those with concurrent tuberculosis, active cytomegalovirus (CMV), Epstein-Barr virus(EBV), hepatitis B, hepatitis C, Human Immunodeficiency Virus(HIV) infection, deep fungal infections, or other active infections;
✕. Patients exhibiting the following abnormal laboratory indicators at the time of initial diagnosis: moderate to severe neutropenia (≤1000/μL); moderate to severe anemia (hemoglobin \<9.0 g/dL); thrombocytopenia (platelet count \<100×10\^12/L); or abnormal liver function (Alanine Aminotransferase(ALT), Aspartate Aminotransferase(AST), or bilirubin exceeding 2.5 times the upper limit of normal and persistently elevated for 2 weeks);
✕. Patients with a history of tumors or severe cardiovascular, digestive system, hematological, endocrine, or other systemic diseases;
✕. Patients with concurrent other urinary system diseases (such as hereditary kidney diseases, etc.);
What they're measuring
1
Complete remission rate of urinary protein [Efficacy]
Timeframe: From enrollment to the 48th week after treatment
2
The rate of change in urinary protein [Efficacy]
Timeframe: From enrollment to the 48th week after treatment
3
The rate of change in urinary protein [Efficacy]
Timeframe: From enrollment to the 48th week after treatment.
Trial details
NCT IDNCT07354503
SponsorThe Children's Hospital of Zhejiang University School of Medicine