Kidney Week

Abstract: TH-PO1258

Sibeprenlimab in IgA Nephropathy: 24 Months of Data from the Phase 3 VISIONARY Trial

Session Information

• Late-Breaking Research Posters
  October 22, 2026 | Location: Exhibit Hall A, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Glomerular Diseases

• 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics

Authors

• Rizk, Dana V., The University of Alabama at Birmingham Heersink School of Medicine, Birmingham, Alabama, United States

Dana V. Rizk, MD

• Barratt, Jonathan, University of Leicester, Leicester, England, United Kingdom

Jonathan Barratt, MBChB, PhD

• Suzuki, Yusuke, Juntendo Daigaku Igakubu Daigakuin Igaku Kenkyuka, Bunkyo, Tokyo, Japan

Yusuke Suzuki, MD, PhD

• Zhang, Hong, Peking University First Hospital, Beijing, China

Hong Zhang, MD, PhD

• Wong, Muh Geot, Concord Repatriation General Hospital, Concord, New South Wales, Australia

Muh Geot Wong, MBBS, PhD

• Liew, Adrian, Mount Elizabeth Hospital, Singapore, Singapore

Adrian Liew, MD, MBBS, FASN

• Lafayette, Richard A., Stanford Medicine, Stanford, California, United States

Richard A. Lafayette, MD

• Tesar, Vladimir, Vseobecna fakultni nemocnice v Praze, Prague, Czechia

Vladimir Tesar, MD, PhD, MBA, FASN

• Trimarchi, Hernan, Hospital Britanico de Buenos Aires, Buenos Aires, Argentina

Hernan Trimarchi, MD, PhD, FASN

• Carroll, Kevin, KJC Statistics Ireland Ltd., Dublin, Ireland

Kevin Carroll, PhD

• Roberts, Ian, Oxford University Hospitals NHS Foundation Trust, Oxford, England, United Kingdom

Ian Roberts, MBChB

• Jha, Vivekanand, The George Institute for Global Health, New Delhi, India

Vivekanand Jha, MD

• Smuclir Quevedo, Maria Alejandra, Investigación Clínica Applicada SRL, Buenos Aires, Argentina

Maria Alejandra Smuclir Quevedo, MD

• Han, Seung Hyeok, Yonsei University College of Medicine, Seodaemun-gu, Seoul, Korea (the Republic of)

Seung Hyeok Han, MD, PhD

• Yahya, Rosnawati, Sunway Medical Centre, Bandar Sunway, Selangor, Malaysia

Rosnawati Yahya, MBChB

• Cheung, Chee Kay, University of Leicester, Leicester, England, United Kingdom

Chee Kay Cheung, MBChB, PhD

• Ramachandran, Raja, Post Graduate Institute of Medical Education and Research, Chandigarh, CH, India

Raja Ramachandran, MD, MBBS

• Walsh, Michael, McMaster University, Hamilton, Ontario, Canada

Michael Walsh, MD, PhD

• Chacko, Bobby, John Hunter Hospital, Newcastle, New South Wales, Australia

Bobby Chacko, MD, MBBS, FASN

• Praga, Manuel, Universidad Complutense de Madrid, Madrid, Spain

Manuel Praga, MD

• Chen, J. B., Kaohsiung Chang Gung Memorial Hospital, Niaosong District, Kaohsiung City, Taiwan

J. B. Chen, MD

• Suassuna, Jose H. R., Universidade do Estado do Rio de Janeiro, Rio de Janeiro, RJ, Brazil

Jose H. R. Suassuna, MD, MS, PhD

• Xia, Jing, Otsuka Pharmaceutical Development and Commercialization Inc, Princeton, New Jersey, United States

Jing Xia, PhD

• Shah, Lokesh N., Otsuka Pharmaceutical Development and Commercialization Inc, Princeton, New Jersey, United States

Lokesh N. Shah, MD, MS

• Perkovic, Vlado, University of New South Wales, Sydney, New South Wales, Australia

Vlado Perkovic, MBBS, PhD, FASN

Background

The VISIONARY trial assessed the effects of sibeprenlimab on kidney outcomes in patients with IgA nephropathy (IgAN). In a prespecified interim analysis, sibeprenlimab significantly reduced proteinuria. This final 24-month analysis provides the first report of the effect of selective inhibition of a proliferation-inducing ligand (APRIL) on kidney function decline and kidney failure as measured by the composite kidney outcome in a phase 3 IgAN trial.

Methods

VISIONARY, a phase 3, double-blind, placebo (PBO)-controlled trial (NCT05248646), randomized adults with IgAN 1:1 to sibeprenlimab 400 mg SC or PBO every 4 weeks. Prespecified endpoints included the annualized eGFR slope over 24 months, time to composite kidney outcome event (sustained ≥40% eGFR decline, sustained doubling of serum creatinine, eGFR <15 mL/min/1.73 m², or kidney replacement therapy [KRT]), proportion of patients experiencing ≥1 kidney outcome event, pharmacodynamics, and safety.

Results

Among 510 randomized patients, the annualized eGFR slope (95% CI) over 24 months was 0.3 (−0.4 to 0.9) with sibeprenlimab vs −4.2 (−4.9 to −3.6) mL/min/1.73 m²/yr with PBO (between-group difference, 4.5 mL/min/1.73 m²/yr; P<0.0001). Time to progression to first occurrence of a composite kidney event favored sibeprenlimab vs PBO (hazard ratio, 0.03; 95% CI, 0.00 to 0.21; P<0.0001), corresponding to a 97.1% reduction in the hazard of events. Fewer patients progressed to at least one composite kidney outcome event with sibeprenlimab vs PBO (1 vs 28): sustained ≥40% eGFR decline (1 vs 28), sustained doubling of serum creatinine (0 vs 13), eGFR <15 mL/min/1.73 m² (1 vs 10), and KRT (0 vs 5). Reductions in serum APRIL and Gd-IgA1 were sustained over 24 months. Safety was comparable between groups, with no increase in serious infections and no deaths.

Conclusion

Sibeprenlimab stabilized kidney function and substantially reduced the risk of progressive kidney function loss and kidney failure in patients with IgAN over 24 months.

Funding

• Commercial Support – Otsuka Pharmaceutical Development & Commercialization, Inc. (Princeton, NJ, USA)