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Kidney Week

Abstract: TH-OR26

eGFR Decline in Patients with IgA Nephropathy Treated with Nefecon or Placebo: Results from the 2-Year NefIgArd Phase 3 Trial

Session Information

Category: Glomerular Diseases

  • 1402 Glomerular Diseases: Clinical, Outcomes, and Trials

Authors

  • Lafayette, Richard A., Division of Nephrology, Department of Medicine, Stanford University, Stanford, California, United States
  • Kristensen, Jens, Calliditas Therapeutics AB, Stockholm, Stockholm County, Sweden
  • Stone, Andrew M., Stone Biostatistics Ltd., Crewe, United Kingdom
  • Floege, Jürgen, Department of Nephrology and Clinical Immunology, Rheinisch Westfälische Technische Hochschule Aachen University Hospital, Aachen, Germany
  • Tesar, Vladimir, Department of Nephrology, First Faculty of Medicine and General University Hospital, Charles University, Prague, Czechia
  • Trimarchi, Hernan, Nephrology Service, Hospital Británico de Buenos Aires, Buenos Aires, Argentina
  • Zhang, Hong, Renal Division, Peking University First Hospital, Peking University Institute of Nephrology, Beijing, China
  • Eren, Necmi, Department of Nephrology, Kocaeli University, Kocaeli, Turkey
  • Paliege, Alexander, Division of Nephrology, Department of Internal Medicine III, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany
  • Reich, Heather N., Division of Nephrology, University Health Network, Department of Medicine, University of Toronto, Toronto, Ontario, Canada
  • Rovin, Brad H., Division of Nephrology, The Ohio State University Wexner Medical Center, Columbus, Ohio, United States
  • Barratt, Jonathan, College of Medicine Biological Sciences and Psychology, University of Leicester, Leicester, United Kingdom
Background

The novel targeted-release budesonide formulation Nefecon is designed to treat immunoglobulin A (IgA) nephropathy (IgAN) by downregulating IgA1 antibody production in the distal ileum. 9-month data from the first 199 patients (pts) in the Phase 3 NefIgArd trial demonstrated significant urine protein–creatinine ratio (UPCR) reduction and estimated glomerular filtration rate (eGFR) preservation with Nefecon vs placebo in pts with IgAN, as reported previously (Barratt J et al. Kidney Int 2023;103:391–402). Here, we present data for the complete study population from the full 2-year trial (9 months of treatment and 15 months of follow-up) comparing eGFR decline (measured as a confirmed 30% reduction in eGFR from baseline) in pts treated with Nefecon 16 mg/day vs placebo.

Methods

Pts (≥18 years) with primary IgAN, eGFR 35–90 mL/min/1.73 m2, proteinuria ≥1 g/24 h despite renin–angiotensin system blockade, and blood pressure <140/90 mmHg, were eligible. A 30% reduction from baseline in eGFR (Chronic Kidney Disease Epidemiology Collaboration formula) was confirmed by 2 values.

Results

364 pts were included in the full analysis set. The proportion of pts with a confirmed 30% eGFR reduction was lower in the Nefecon vs placebo arm (Figure). The time to a confirmed 30% reduction was significantly delayed with Nefecon vs placebo (hazard ratio [HR] 0.45 [95% confidence interval 0.26–0.75]; p=0.0014 [1-sided]). A pre-defined supplementary analysis with rescue medication use included as an event yielded a similar result (HR 0.51). Baseline UPCR (<1.5 and ≥1.5 g/g) did not affect outcome (HR 0.51 and 0.42, respectively).

Conclusion

The significantly longer time to a confirmed 30% reduction in eGFR with Nefecon vs placebo strongly indicates preserved kidney function and supports the role of Nefecon as a disease-modifying therapy.

Funding

  • Commercial Support – Calliditas Therapeutics