This is an open-label randomized controlled trial to evaluate the efficacy and safety of one dose versus two doses of ripertamab in children with frequent relapses or steroid-dependent nephrotic syndrome (FRNS/SDNS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
312
2 doses of 375mg/m2 BSA ripertamab at 1-week intervals( within ±1days). At the meantime, prednisone is administered at a dose of 1.5 mg/kg/d (maximum 40 mg) on alternate days or at the dose being used every alternate day before randomization. After 2 weeks, the dose is reduced by 0.25 mg/kg every 2 weeks, and the drug is discontinued at 3 months.
1 dose of 375mg/m2 BSA ripertamab. At the meantime, prednisone is administered at a dose of 1.5 mg/kg/d (maximum 40 mg) on alternate days or at the dose being used every alternate day before randomization. After 2 weeks, the dose is reduced by 0.25 mg/kg every 2 weeks, and the drug is discontinued at 3 months.
Children's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province 310052
Hangzhou, Zhejiang, China
Relapse free survival rate
Relapse free survival rate at 1 year
Time frame: 1 year
Recurrence frequency at 6 and 12 months
Recurrence frequency within 6 months during the study period. Recurrence frequency within 12 months during the study period.
Time frame: 1 year
Cumulative corticosteroid dose
Total amount of corticosteroids used in 1 year during the study period
Time frame: 1 year
Median recurrence-free survival
From admission day to 18 months
Time frame: 18 months
B-cell count
Time frame: 18 months
The occurrence and severity of adverse events
Time frame: 18 months
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