eligibility_summary
Inclusion: age 3–18, steroid‑dependent NS (≥2 relapses on/≤2 wks after steroids or on/≤6 mo after steroid‑sparing) or frequent relapsing NS (≥2 in 6 mo or ≥3 in 12 mo), last relapse ≤3 mo, in remission, vaccines up to date, parental consent. Exclusion: secondary or steroid‑resistant NS, RTX <6 mo or obinutuzumab, CD20+<2.5%, ANC<1.5 or platelets<75, GFR<80, weight<16 kg, serious/uncontrolled infection or malignancy, live vaccine <4 wks, hyperprolinemia, hypersensitivity, pregnant/breastfeeding/no contraception, no insurance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Double-blind phase II/III RCT in children with steroid-dependent or frequently relapsing nephrotic syndrome compares a single infusion of obinutuzumab (300 mg/1.73 m2) vs rituximab (375 mg/m2). Interventions: both are anti-CD20 monoclonal antibodies that deplete B cells. Rituximab is a chimeric, type I mAb, it kills CD20+ B cells mainly via complement-dependent cytotoxicity (CDC) and antibody-dependent cellular cytotoxicity (ADCC). Obinutuzumab is a humanized, glycoengineered, type II mAb with enhanced FcγRIIIa binding, producing stronger ADCC and direct cell death, yielding deeper and more sustained B-cell depletion, including in lymphoid tissues, potentially overcoming rituximab resistance. Targets/pathways: CD20 on naïve and memory B cells, reduction of B-cell antigen presentation, cytokine signaling, and precursors of autoantibody production that drive INS relapses.