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Otsuka Pharmaceutical reports kidney function preservation in IgAN study
Otsuka Pharmaceutical has announced final 24-month results from its phase 3 Visionary study, demonstrating that sibeprenlimab helps preserve kidney function in adults with primary IgA nephropathy (IgAN) at risk of disease progression.
The study reported a 97.1% reduction in the risk of a composite renal outcome—defined as renal function decline or renal failure—compared to a placebo. Among 510 randomized patients, only one patient treated with sibeprenlimab (0.4%) progressed to the composite renal outcome, compared to 28 patients in the placebo group (11.2%).
This is the first phase 3 study in IgAN to meet the KDIGO 2025 therapeutic goal of slowing renal function decline to near-physiological levels (eGFR decline <1 mL/min/1.73 m²/year for many adults). The findings, which support the selective inhibition of the April protein, were presented at the American Society of Nephrology Kidney Week 2026 and published in The New England Journal of Medicine.
Entities
American Society of Nephrology · Otsuka Pharmaceutical · The New England Journal of Medicine