Telitacicept in the Treatment of Pediatric IgA Vasculitis-Associated Nephritis

ConditionsIgAVN IgA Vasculitis

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

This trial does not accept healthy volunteers

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 population

Collect patients diagnosed with childhood IgA vasculitis nephritis who received treatment with glucocorticoids and/or telitacicept during the treatment period and met the inclusion and exclusion criteria.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

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

Treatment groups

300 Participants

are divided into 3 treatment groups

Group A: Glucocorticoids group2 interventions

Group B: Telitacicept group2 interventions

Group C: Glucocorticoids combined Telitacicept group2 interventions

Trial outcomes

Primary outcomes

Complete remission rate of urinary protein [Efficacy]

Compared to the baseline, the investigators will assess the proportions of participants with a urine protein-to-creatinine ratio (UPCR) \< 0.2 mg/mg (or 20 mg/mmol) or 24-hour urinary protein quantification\< 0.2 g/d at weeks 12, 24, and 48 after medication administration.

Time frame

From enrollment to the 48th week after treatment

The rate of change in urinary protein [Efficacy]

The investigators will assess the UPCR(mg/mg or mg/mmol) of participants at 12, 24, and 48 weeks after medication administration, comparing the results against the baseline and conducting inter-group comparisons.

Time frame

From enrollment to the 48th week after treatment

The rate of change in urinary protein [Efficacy]

The investigators will assess 24-hour urine protein quantification(g/d) of participants at 12, 24, and 48 weeks after medication administration, comparing the results against the baseline and conducting inter-group comparisons.

Time frame