Rituximab in the First Episode of Paediatric Nephrotic Syndrome (NCT05850546) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Rituximab in the First Episode of Paediatric Nephrotic Syndrome
China138 participantsStarted 2025-03-01
Plain-language summary
The study will be a randomized, open-label trial in children with the initial episode of SSNS and whose state of complete remission after received standard prednisolone, to determine whether rituximab (a single intravenous infusion of 375 mg/m2) would be noninferior to corticosteroid alone in maintaining complete disease remission during 12-month of follow-up.
Who can participate
Age range1 Year – 18 Years
SexALL
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Inclusion criteria
✓. Children between 1 and 18 years with Steroid-Sensitive Nephrotic Syndrome (nephrotic-range proteinuria and either hypoalbuminemia or edema when albumin level is not available)
✓. Estimated glomerular filtration rate (eGFR) ≥90 ml/min per 1.73 m2 at study entry
✓. Remission at study entry
✓. the cluster of differentiation antigen 20 (CD20) positive cells in peripheral blood ≥1% total lymphocytes
✓. No immunosuppressive agents have been used within 3 months of enrolment, except for the use of corticosteroid to treat nephrotic syndrome
✓. Provision of consent by a legal representative using a document approved by the institutional review board after receiving an adequate explanation of this clinical trial. For children ages 8-18, written assent is required using age-appropriate and background-appropriate documents
Exclusion criteria
✕. Diagnosis of secondary NS
✕. Patients showing one of the following abnormal clinical laboratories
✕. values: leukopenia (white blood cell count ≤3.0\*109/L); moderate and severe anemia (hemoglobin \<9.0g/dL); thrombocytopenia (platelet count \<100\*1012/ L); positivity of autoimmunity tests (ANA, Anti DNA antibody, ANCA) or reduced C3 levels; Alanine aminotransferase or aspartate aminotransferase \> 2.5× upper limit of normal value
✕. Presence of severe or chronic infections within 6 months before assignment: tuberculosis or in whom tuberculosis is suspected; Epstein-Barr virus or cytomegalovirus; hepatitis B or hepatitis C or hepatitis B virus carrier, human immunodeficiency virus or other active viral infections