eligibility_summary
Include: FRNS/SDNS dx <18, in complete remission (no edema, UPCR ≤0.2, 3 trace/neg dips), ≥1 relapse in past 6 mo (post‑cyclophosphamide if used), normal age‑adjusted eGFR, contraception: F through 18 mo post‑obinutuzumab/6 wks post‑MMF, M through 90 d post‑MMF. Exclude: secondary/steroid‑resistant/genetic NS, recent other IS, pregnant/breastfeeding, transplant, recent trial, drug intolerance, prior MMF failure, non‑NS steroid need, active infection, immunodeficiency/HIV/PML, cancer ≤5 y, recent major surgery, bleeding risk/need plasma/IVIG/transfusion, major comorbidities, substance abuse.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05627557 (Phase III) compares two immunosuppressive strategies in children/young adults with frequently relapsing or steroid‑dependent idiopathic nephrotic syndrome. Obinutuzumab: type II, glycoengineered anti‑CD20 monoclonal antibody, depletes CD20+ B cells via ADCC and direct cell death, reducing pathogenic humoral immunity and B–T cell crosstalk. MMF (mycophenolate mofetil): oral antimetabolite immunosuppressant, prodrug of mycophenolic acid that inhibits IMPDH, blocking de novo guanine synthesis and selectively suppressing proliferation of activated T and B lymphocytes and antibody production. Background meds: prednisone (glucocorticoid receptor agonist, broad cytokine/lymphocyte suppression), methylprednisolone, acetaminophen, and diphenhydramine used mainly as taper/premedication. Targets/pathways: CD20+ B‑cell depletion, IMPDH‑mediated purine synthesis in lymphocytes, and glucocorticoid signaling to curb immune‑mediated podocyte injury/relapse.