Results From the VISIONARY Clinical Trial of Sibeprenlimab in Patients With IgA Nephropathy

Vlado Perkovic, MD, Professor of Medicine and Provost at the University of New South Wales Sydney, discusses results from the VISIONARY clinical trial testing Voyxact (sibeprenlimab) in patients with IgA nephropathy (IgAN). IgAN is due to the accumulation of IgA protein in the kidneys. In the early stages, IgAN has no symptoms. The first sign of this condition may be blood in the urine. End-stage kidney disease may develop if the disease is not treated properly. In most instances, the cause of this condition is unknown; however, certain disorders have been linked with IgAN, such as cirrhosis of the liver, celiac disease, and HIV infection. The condition can also often be triggered by a viral illness. Sibeprenlimab is a humanized monoclonal antibody that binds to and blocks A-PRoliferation-Inducing Ligand (APRIL), reducing levels of serum galactose-deficient IgA1 (Gd-IgA1). The therapy is a self-administered, subcutaneous injection dosed once every four weeks, and was granted accelerated approval by the US Food and Drug Administration (FDA) in November 2025. Interim results from the phase 3 VISIONARY clinical trial were presented at the European Renal Association (ERA) Congress 2026. This study is ongoing and is evaluating the long-term safety and efficacy of sibepreblimab in preserving kidney function in patients with IgAN. In the 152 patients treated with sibeprenlimab, an increase in the mean estimated glomerular filtration rate (eGFR) change from baseline of +0.7 mL/min/1.73 m² was observed, compared to a decline of -4.8 mL/min/1.73 m² in the placebo-treated arm. At 12 months, sibeprenlimab showed a mean eGFR change from baseline that meets the KDIGO treatment goal to reduce the annual kidney function decline to the normal physiological rate of less than 1 mL/min/1.73 m2/year. Additionally, the annualized slope of eGFR showed -3.0 mL/min/1.73 m²/year with sibeprenlimab compared to -7.6 mL/min/1.73 m²/year with placebo over 12 months. Sibeprenlimab was well tolerated with a favorable safety profile in line with previously reported data. The most common adverse events were infections and injection site reactions. Additional longer-term assessments are planned in the Phase 2/3 open-label extension study (NCT05248659). CHAPTERS Introduction 00:00 IgAN Overview 00:16 Shifts in Management 1:37 Autoimmune Component of Disease 2:38 VISIONARY Clinical Trial 4:28 Slowing Damage and Potential for Reversing 8:15 Safety of Sibeprenlimab 9:14