eligibility_summary
Eligible: 18-80 with biopsy-proven primary minimal change disease (initial therapy), nephrotic-range proteinuria (24h-UTP >3.5 g/d or PCR >3500 mg/g) and albumin <30 g/L, and consent. Exclude: secondary MCD, eGFR <60, major comorbidities or GI bleeding, prior steroids/immunosuppressants, HBV/HCV/HIV/other active infections/immunodeficiency, recent live vaccine, significant liver dysfunction, allergy to study drugs, pregnancy/lactation or poor contraception, substance abuse, inability to consent.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 3, multicenter RCT in initial minimal change disease testing: 1) Ripertamab (anti-CD20 monoclonal antibody, biologic) ± tacrolimus vs 2) standard prednisolone (glucocorticoid), all with supportive care. Mechanisms: • Ripertamab targets CD20 on B lymphocytes, depleting B cells via ADCC/CDC and apoptosis, aiming to reduce immune drivers of proteinuria. • Tacrolimus (calcineurin inhibitor, small-molecule immunosuppressant) binds FKBP12 to block calcineurin–NFAT signaling, lowering IL‑2 and T‑cell activation, it also stabilizes podocyte actin cytoskeleton, reducing permeability/proteinuria. • Prednisolone (systemic GR agonist, steroid) broadly suppresses cytokine transcription and T‑cell activity. Targeted cells/pathways: CD20+ B cells, T‑cell calcineurin–NFAT/IL‑2 axis, and podocyte cytoskeleton.