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Two drugs for IgA nephropathy — atacicept and sibeprenlimab — dramatically slowed kidney function decline in final phase III trial results, paving the way for full FDA approvals. The ORIGIN and VISIONARY trials both showed striking benefits over placebo, with sibeprenlimab cutting the risk of major kidney events by 97%. Experts say these results make a compelling case for wider clinical use.
Two immune-targeting drugs for IgA nephropathy — atacicept (Trutakna) and sibeprenlimab (Voyxact) — have delivered strong final phase III results, confirming their ability to meaningfully slow kidney function decline. Both drugs had previously received accelerated FDA approval based on interim data showing reduced proteinuria; these final analyses now fulfill the requirement to demonstrate preserved kidney function, setting the stage for full traditional approvals.
In the ORIGIN trial, atacicept reduced the annualized eGFR decline to just -0.60 mL/min/1.73 m² per year, compared to -5.60 in the placebo group — a difference that translates to preventing roughly 12 mL of kidney function loss over two years. In the VISIONARY trial, sibeprenlimab actually stabilized eGFR at +0.3 mL/min/1.73 m² per year vs. -4.2 for placebo. Both trials were simultaneously published in the New England Journal of Medicine.
By the Numbers:
Why it matters: IgA nephropathy progresses silently and can lead to kidney failure. These results show that B-cell-directed therapies can bring eGFR decline in line with normal physiological aging — a benchmark set by 2025 KDIGO guidelines. Experts say it will be hard to justify withholding these therapies from high-risk patients.
