Kidney Week

Abstract: TH-PO0465

Slowing of Kidney Function Decline to Physiological Rates with Nefecon in Patients with IgAN: A NefIgArd Subanalysis

Session Information

• Glomerular Diseases: Clinical, Outcomes, and Therapeutics Research - IgAN
  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

• Rovin, Brad, Division of Nephrology, The Ohio State University Wexner Medical Center, Columbus, Ohio, United States

Brad Rovin, MD, FASN

• Lafayette, Richard A., Division of Nephrology, Department of Medicine, Stanford University, Stanford, California, United States

Richard A. Lafayette, MD

• Norouzi, Sayna, Division of Nephrology, Loma Linda University Medical Center, Loma Linda, California, United States

Sayna Norouzi, MD, FASN

• Reich, Heather N., Division of Nephrology, University Health Network, Department of Medicine, University of Toronto, Toronto, Ontario, Canada

Heather N. Reich, MD, PhD

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

Dana V. Rizk, MD

• Jones, Russell, Calliditas Therapeutics AB, Stockholm, Sweden

Russell Jones, MSc

• Mitchev, Krassimir, Calliditas Therapeutics AB, Stockholm, Sweden

Krassimir Mitchev, MD, PhD

• Barratt, Jonathan, College of Life Sciences, University of Leicester, Leicester, United Kingdom

Jonathan Barratt, MBChB, PhD

Background

The NefIgArd trial investigated the efficacy and safety of nefecon, a targeted-release budesonide formulation, in patients with immunoglobulin A nephropathy (IgAN). Nefecon significantly reduced the urine protein-creatinine ratio and had a beneficial effect on estimated glomerular filtration rate (eGFR) versus placebo; it was the first fully approved agent for the treatment of IgAN. The Kidney Disease: Improving Global Outcomes 2025 guideline states that the treatment goal for IgAN patients at risk of progressive kidney function loss should be to reduce this loss to ‘physiological levels’ (eGFR <1 mL/min/1.73 m² per year). In this subanalysis, we analyzed those patients who had a decline in eGFR of <1 mL/min/1.73 m² at different visits during the trial.

Methods

The NefIgArd trial has been described previously (Lafayette R, et al. Lancet 2023;402:859-870). In brief, patients were randomized 1:1 to receive nefecon 16 mg/d or placebo plus standard of care for 9 months followed by 15 months off treatment. In this subanalysis, patients were categorized at each visit based on an eGFR decline from baseline of <1 or ≥1 mL/min/1.73 m². Odds ratios were used to compare nefecon versus placebo with eGFR <1 mL/min/1.73 m² as the outcome. Confidence intervals were calculated using the Wald method on the log-odds scale. The p-values were obtained from Fisher’s exact test.

Results

Of the 182 patients in each arm of the NefIgArd trial, significantly more patients receiving nefecon (61%) than placebo (33%) experienced a reduction in eGFR loss to <1 mL/min/1.73 m² at 9 months. Similar findings were reported at 12 and 24 months (Table).

Conclusion

The addition of nefecon to standard of care for individuals with IgAN leads to a significant improvement in eGFR loss, with more patients reaching the goal of losing less than 1 mL/min/1.73 m² than with standard of care alone. This supports the implementation of nefecon as a disease-modifying treatment as early as possible in the disease course.

Acknowledgment

This trial was funded by Calliditas Therapeutics AB, an Asahi Kasei company. Medical writing assistance was provided by Lily Wills-Gray of OHMC, London, UK, with financial support from Calliditas Therapeutics AB and in accordance with the 2022 Good Publication Practice guidelines (https://www.ismpp.org/gpp-2022).

Proportions of patients experiencing eGFR decline of <1 mL/min/1.73 m² from baseline at 9, 12, and 24 months

CI, confidence interval; OR, odds ratio.

Funding

• Commercial Support – Calliditas Therapeutics AB (an Asahi Kasei company)