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NCT07354503

Telitacicept in the Treatment of Pediatric IgA Vasculitis-Associated Nephritis

Sponsor: The Children's Hospital of Zhejiang University School of Medicine

View on ClinicalTrials.gov

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.

Official title: The Efficacy and Safety of Telitacicept in the Treatment of Pediatric IgA Vasculitis-Associated Nephritis: A Multicenter Clinical Study

Key Details

Gender

All

Age Range

3 Years - 17 Years

Study Type

OBSERVATIONAL

Enrollment

300

Start Date

2026-01-01

Completion Date

2028-06-30

Last Updated

2026-01-21

Healthy Volunteers

Conditions

IgAVN IgA Vasculitis

Interventions

DEVICE

Collect clinical data from the patients.

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

DRUG

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

Inclusion Criteria: 1. Age 3-17 years; 2. Patients diagnosed with IgA vasculitis nephritis (IgAVN) based on clinical manifestations and renal pathological diagnosis; 3. Urinary protein quantification requirements: urinary protein/creatinine ratio (UPCR) of ≥1 mg/mg (100 mg/mmol); 4. Estimated glomerular filtration rate (eGFR) calculated using the modified Schwartz formula of ≥60 mL/min/1.73 m². 5. 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: 1. 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; 2. 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); 3. Patients with a history of tumors or severe cardiovascular, digestive system, hematological, endocrine, or other systemic diseases; 4. Patients with concurrent other urinary system diseases (such as hereditary kidney diseases, etc.); 5. Subjects with severe osteoporosis requiring treatment; 6. Subjects diagnosed with uncontrolled mental illness or intellectual disabilities; 7. Subjects who have received B-cell targeted therapy within the last 6 months; 8. History of major organ transplant or hematopoietic stem cell/cell/bone marrow or kidney transplant; 9. Vaccination with live attenuated vaccines within 1 month prior to treatment; 10. Use of various traditional Chinese medicines for treating kidney diseases during the treatment period (patients who have previously used traditional Chinese medicine can be included, but are strictly prohibited from using it after receiving treatment according to the protocol); 11. Incomplete clinical data.