OBIRINS Trial
OBIRINS is the first direct head-to-head comparison of rituximab and obinutuzumab in children with idiopathic nephrotic syndrome. The trial requires 88 patients (42 per arm), powered at 90% to detect a difference between 90% relapse-free s…
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OBIRINS is the first direct head-to-head comparison of rituximab and obinutuzumab in children with idiopathic nephrotic syndrome. The trial requires 88 patients (42 per arm), powered at 90% to detect a difference between 90% relapse-free survival in the OBI group and 60% in the RTX group at 12 months. Blinding in OBIRINS is maintained for physicians, nurses, patients, and parents; only the local pharmacist is unblinded to prepare infusions. A principal limitation of OBIRINS is that post-relapse treatment is not protocolised, preventing formal comparison of outcomes beyond the first relapse. The primary outcome is the occurrence of the first relapse within 12 months of treatment initiation. OBIRINS is a national, multicentre, double-blind, randomised, parallel-group superiority trial conducted across 13 tertiary paediatric nephrology centres in France. OBIRINS includes a formal cost-effectiveness analysis and longitudinal biobanking as secondary components.