The main objective is to evaluate the effectiveness of telitacicept in pediatric patients with frequently relapsing or steroid dependent nephrotic syndrome within the 52-week follow-up.
Sensitive but frequent relapses or steroids dependence nephrotic syndrome
Age: 2 to 18 years old
Normal renal function: estimated glomerular filtration rate ≥90ml/ min/1.73m2
Morning urine protein <1+ or urine protein-creatinine ratio <0.2g/g (<20 mg/ mmol) for 3 consecutive days and above when in enroll
Family history of nephrotic syndrome, chronic glomerulonephritis or uremia
Leukopenia (White Blood Cells ≤ 3.0 * 10^9 / L)
Moderate to severe anemia (hemoglobin <9.0 g/dL)
Thrombocytopenia (platelet count <100*10^12/L)
Single group
Telitacicept
DrugThe study duration was 52 weeks, with the experimental group receiving subcutaneous injections of Telitacicept once weekly for a total of 52 weeks.
1-year relapse-free survival rate
The rate of no relapse within 1 year
Relapse of nephrotic syndrome during 12 months after enrollment
Proportion of patients with one or more relapse(s) of nephrotic syndrome
Number of relapses during 12 months follow up
Number of nephrotic syndrome relapses per patient year during the 12 months period after enrollment
The first time to relapse
The first time to relapse after patients taking part in this study
Cumulative prednisone dosage (milligrams per kilogram per year)
The total dosage of prednisones from the beginning to the end of the trial
Adverse event
The number of harmful reactions and the types of adverse events during the study
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