Telitacicept in the Treatment of Pediatric IgA Vasculitis-Associated Nephritis

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-17
SponsorThe Children's Hospital of Zhejiang University School of Medicine

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.);

Trial design

Treatments tested in this trial

  • Collect clinical data from the patients.
  • This study exclusively prospectively collected clinical data from the patients and did not involve any therapeutic interventions

Treatment groups

300 Participants
are divided into 3 treatment groups

Locations

This trial has no locations