ASN's Mission

To create a world without kidney diseases, the ASN Alliance for Kidney Health elevates care by educating and informing, driving breakthroughs and innovation, and advocating for policies that create transformative changes in kidney medicine throughout the world.

learn more

Contact ASN

1401 H St, NW, Ste 900, Washington, DC 20005

email@asn-online.org

202-640-4660

The Latest on X

Kidney Week

Abstract: INFO14-TH

The BEYOND Trial: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Zigakibart in Adults with IgA Nephropathy

Session Information

  • Informational Posters - I
    November 02, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
    Abstract Time: 10:00 AM - 12:00 PM

Category: Glomerular Diseases

  • No subcategory defined

Authors

  • Campbell, Kirk N., Icahn School of Medicine at Mount Sinai, New York, New York, United States
  • Barratt, Jonathan, University of Leicester, Leicester, United Kingdom
  • Radhakrishnan, Jai, Columbia University Irving Medical Center, New York, New York, United States
  • Rizk, Dana V., University of Alabama at Birmingham, Birmingham, Alabama, United States
  • Trimarchi, Hernan, Hospital Britanico de Buenos Aires, Buenos Aires, Argentina
  • Khawaja, Zeeshan, Chinook Therapeutics Inc, Seattle, Washington, United States
  • Leiske, Jocelyn, Chinook Therapeutics Inc, Seattle, Washington, United States
  • Sorensen, Bess, Chinook Therapeutics Inc, Seattle, Washington, United States
  • King, Andrew J., Chinook Therapeutics Inc, Seattle, Washington, United States
  • Jones-Burton, Charlotte, Chinook Therapeutics Inc, Seattle, Washington, United States
  • Perkovic, Vlado, University of New South Wales, Sydney, New South Wales, Australia
Description

IgA nephropathy (IgAN) is the leading cause of primary glomerulonephritis and has limited treatment options. Zigakibart is a novel, humanized monoclonal antibody that blocks APRIL (a proliferation-inducing ligand), a cytokine that is elevated in patients with IgAN and promotes the production of pathogenic galactose-deficient IgA1 (Gd-IgA1), leading to inflammation and kidney injury. Blocking APRIL with zigakibart is a potential disease-modifying approach to treat IgAN.

BEYOND is a Phase 3, randomized, double-blind, placebo-controlled trial to evaluate zigakibart in adults with primary IgAN at risk of progressive kidney function loss (NCT05852938). Approximately 272 patients will be enrolled globally. Key eligibility criteria include biopsy-proven IgAN in the past 10 yrs, eGFR ≥30 ml/min/1.73m2 and total urine protein ≥1.0 g/d at screening. An exploratory cohort, not included in the primary analysis, will enroll approximately 20 additional patients with eGFR of ≥ 20 to < 30 mL/min/1.73 m2. Patients must be on a stable, max-tolerated dose of RASi for ≥12 wks prior to screening or intolerant to RASi. Patients may also be on a stable dose of SGLT2i, MRA and/or endothelin receptor antagonists for ≥12 wks prior to screening.

The study includes a 6-wk screening period, a 104-wk double-blind treatment period, and a 24-wk safety follow-up period. Patients will be randomized 1:1 to receive subcutaneous 600 mg zigakibart Q2W or placebo for 104 wks. Randomization will be stratified by region, baseline proteinuria and eGFR.

The primary endpoint is change in UPCR from baseline to wk 36. The key secondary endpoint is change in eGFR from baseline to wk 104. Additional secondary endpoints will evaluate composite clinical outcomes including patients experiencing at least one of the following: 30% or 40% reduction in eGFR, eGFR <15 mL/min/1.73m2, dialysis, kidney transplantation or all-cause mortality. Safety endpoints include type, incidence, severity, and relatedness of adverse events (AEs) and serious AEs. Exploratory endpoints include impact of zigakibart on disease biomarkers and health-related quality of life as well as analysis of zigakibart pharmacokinetics and immunogenicity.

Funding

  • Chinook Therapeutics