The goal of this clinical trial is to evaluate the efficacy and safety of rituximab(RTX) and mycophenolate mofetile(MMF) in the treatment of children with low-dose steroid-dependent nephrotic syndrome(SDNS).
Children with a definite diagnosis of SDNS are included in the study during relapse treatment.
Age 3-16 years.
Steroid dependent dose≤0.3mg/kg/day.
Cumulative steroid use for ≥6 months.
Diagnosis of secondary NS, such as secondary to lupus nephritis, hepatitis B-related nephritis, purpura nephritis, etc.
Anti-neutrophil cytoplasmic antibodies(ANCA) positive or complement C3 level decreased.
Diagnosis of hereditary nephrotic syndrome.
Full dose of prednisone (2mg/kg/day, maximum 60mg) are used for 14 days after relapse and urine protein don't turn negative.
Parallel
Rituximab
Drug2 doses of rituximab 375 mg/m\^2(maximum 500mg/day) at 6 months intervals. Half an hour before rituximab infusion: oral acetaminophen 15mg/kg, oral or intramuscular antihistamine, methylprednisolone 2mg/kg IV. Trimethoprim-sulfamethoxazole should be administered orally from the initiation of rituximab therapy until peripheral-blood B cell recovery to prevent pneumocystis infection.
Mycophenolate Mofetil
DrugMycophenolate Mofetil 20-30 mg/kg/day BID,then adjust the dosage of drugs(maximum 2g/day) to maintian the concentration for MPA-AUC is 30-50μg.h/ml. Total duration:1year. Steroids dose:1.5mg/kg(maximum 40mg) qod for 2 weeks and gradually taper by 0.3 mg/kg every 2 weeks
12-month relapse-free survival rate
The rate of no relapse within 12 months.
6-month relapse-free survival
Relapse-free survival within 6 months.
6-month relapse-free survival rate
The rate of no relapse within 6 months.
12-month relapse-free survival
Relapse-free survival within 12 months.
Proportion of frequent relapses
The proportion of frequent relapses.Frequent relapsing NS:≥2 relapses per 6 months within 6 months of disease onset or ≥4 relapses per 12 months in any subsequent 12-month period.
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