Kidney Week

Abstract: FR-OR064

Zigakibart Results in Sustained Proteinuria Reduction and Remission Through 124 Weeks of Treatment in Patients with IgAN

Session Information

• New IgAN Therapies: Subgroups, Outcomes, and Biomarkers
  October 23, 2026 | Location: Room 501, Convention Center
  Abstract Time: 04:30 PM - 04:40 PM

Category: Glomerular Diseases

• 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics

Authors

• Kooienga, Laura, Colorado Kidney Care, Denver, Colorado, United States

Laura Kooienga, MD

• Lee, Eun Young, Soonchunhyang University Cheonan Hospital, Cheonan, Korea (the Republic of)

Eun Young Lee, MD, PhD

• Moradi, Hamid, Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, United States

Hamid Moradi

• Eliasson Vinterberg, Johanna Sofia Justine, Novartis Pharma AG, Basel, BS, Switzerland

Johanna Sofia Justine Eliasson Vinterberg, MD, PhD

• Lin, Cong, Novartis, Shanghai, China

Cong Lin, PhD

• Barratt, Jonathan, The Mayer IgA Nephropathy Laboratories, University of Leicester, Leicester, United Kingdom

Jonathan Barratt, MBChB, PhD

Background

IgAN is a progressive immune-mediated kidney disease with limited approved treatments. Zigakibart, a humanized monoclonal antibody, targets a proliferation-inducing ligand (APRIL) – a cytokine directly implicated in IgAN pathogenesis. This analysis evaluated long-term proteinuria remission, changes in galactose-deficient IgA1 (Gd-IgA1), serum Ig levels and safety through 124 weeks of zigakibart treatment in patients with IgAN.

Methods

ADU-CL-19 (Part 3; NCT03945318) enrolled 40 adults (median age 40 yrs; 70% male; 60% White, 33% Asian) with biopsy-confirmed IgAN, total UPE ≥0.5 g/24h or 24h UPCR ≥0.5 g/g, eGFR ≥30 mL/min/1.73 m², and receiving a stable/optimized dose of RASi for ≥3 months before screening (or RASi intolerant). Patients received zigakibart 450 mg every 2 weeks (Q2W) intravenously, transitioning to 600 mg Q2W subcutaneously (SC) at ≥24 weeks (Cohort 1, n=10) or 600 mg Q2W SC (Cohort 2, n=30) for up to 124 weeks.

Results

Proteinuria remission (UPE <0.5 g/24h) was observed from Week 4, with an increasing proportion of patients meeting remission criteria over time, reaching 64% at Week 124 (Figure 1A). Sustained suppression of Gd-IgA1 and IgA was observed through Week 124, with mean reductions of –81% and –77% from baseline, respectively. Descriptive analyses showed substantial reductions in Gd-IgA1 across both remission and non-remission groups at all timepoints. Reductions were numerically greater in the remission group at Week 52, but between-group differences decreased over time (Figure 1B).

Conclusion

Zigakibart treatment was associated with increasing and durable proteinuria remission and sustained Gd-IgA1 and IgA suppression through 124 weeks. Exploratory analyses did not suggest a clear difference in Gd-IgA1 reductions between patients with and without proteinuria remission.

Acknowledgment

Professional medical writing assistance was provided by Maria Alfaradhi (Novartis Pharmaceuticals UK) and funded by Novartis Pharma AG.

Funding

• Commercial Support – Novartis Pharma AG