OBIRINS Trial

Uses

Dosage & preparation

Preparation

Risks & contraindications

Comparisons

Highlighted claims

• OBIRINS is the first direct head-to-head comparison of rituximab and obinutuzumab in children with idiopathic nephrotic syndrome. — Obinutuzumab versus Rituximab to maintain remission in children with steroid-dependent and frequently relapsing nephrotic syndrome: the OBIRINS study protocol, a double-blind randomised controlled trial
• OBIRINS is a national, multicentre, double-blind, randomised, parallel-group superiority trial conducted across 13 tertiary paediatric nephrology centres in France. — Obinutuzumab versus Rituximab to maintain remission in children with steroid-dependent and frequently relapsing nephrotic syndrome: the OBIRINS study protocol, a double-blind randomised controlled trial
• The primary outcome is the occurrence of the first relapse within 12 months of treatment initiation. — Obinutuzumab versus Rituximab to maintain remission in children with steroid-dependent and frequently relapsing nephrotic syndrome: the OBIRINS study protocol, a double-blind randomised controlled trial
• 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. — Obinutuzumab versus Rituximab to maintain remission in children with steroid-dependent and frequently relapsing nephrotic syndrome: the OBIRINS study protocol, a double-blind randomised controlled trial
• Blinding in OBIRINS is maintained for physicians, nurses, patients, and parents; only the local pharmacist is unblinded to prepare infusions. — Obinutuzumab versus Rituximab to maintain remission in children with steroid-dependent and frequently relapsing nephrotic syndrome: the OBIRINS study protocol, a double-blind randomised controlled trial
• A principal limitation of OBIRINS is that post-relapse treatment is not protocolised, preventing formal comparison of outcomes beyond the first relapse. — Obinutuzumab versus Rituximab to maintain remission in children with steroid-dependent and frequently relapsing nephrotic syndrome: the OBIRINS study protocol, a double-blind randomised controlled trial
• OBIRINS includes a formal cost-effectiveness analysis and longitudinal biobanking as secondary components. — Obinutuzumab versus Rituximab to maintain remission in children with steroid-dependent and frequently relapsing nephrotic syndrome: the OBIRINS study protocol, a double-blind randomised controlled trial