Study of Rituximab Monotherapy on Children With New-onset Nephrotic Syndrome: A Randomized Controlled Trial
Study of Rituximab Monotherapy VS Steroid Therapy on Children With New-onset Nephrotic Syndrome: A Randomized Controlled Trial
The Children's Hospital of Zhejiang University School of Medicine
80 participants
Feb 9, 2023
INTERVENTIONAL
Conditions
Summary
The main objective is to evaluate the effectiveness of Rituximab monotherapy versus steroid therapy on children with new-onset nephrotic syndrome within the 52-week follow-up.
Eligibility
Plain Language Summary
Simplified for easier understanding
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Interventions
Rituximab dose: 4 doses of 375 mg/m2 rituximab at 1-week intervals( within +7 days), associated with trimethoprim-sulfamethoxazole(25-50 mg/kg/day orally twice per day, 3 days per week. If the patient is not allergic) for three months from the first rituximab dosing date(Day 1). Four doses of rituximab are necessary whether the patient achieves complete remission.
Daily oral prednisone/prednisolone 2 mg/kg/d (maximum 60 mg/d) for 6 weeks followed by alternate day prednisone/prednisolone, 1.5 mg/kg (maximum of 50 mg), for other 6 weeks. Vitamin D and calcium(adjusted according to the blood calcium level) were administered for three months.
Locations(1)
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NCT05734794