Kidney Week

Abstract: FR-OR071

Efficacy and Safety of Extended Nefecon Therapy in IgAN: A Real-World Retrospective Study

Session Information

• New IgAN Therapies: Subgroups, Outcomes, and Biomarkers
  October 23, 2026 | Location: Room 501, Convention Center
  Abstract Time: 05:40 PM - 05:50 PM

Category: Glomerular Diseases

• 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics

Authors

• Zhu, Mingxiang, Peking University First Hospital Department of Nephrology, Beijing, China

Mingxiang Zhu, PhD

• Yang, Hongyu, Peking University First Hospital Department of Nephrology, Beijing, China

Hongyu Yang

• Lv, Jicheng, Peking University First Hospital Department of Nephrology, Beijing, China

Jicheng Lv, MD

• Zhang, Hong, Peking University First Hospital Department of Nephrology, Beijing, China

Hong Zhang, MD, PhD

Background

Nefecon, an oral formulation of budesonide, is the first drug to receive accelerated approval treating immunoglobulin (Ig) A nephropathy (IgAN) in patients at risk of rapid progression. The 2025 KDIGO guidelines suggest reduced-dose maintenance therapy with Nefecon given that proteinuria and galactose-deficient IgA1 (Gd-IgA1) began to rebound within 3 months after drug discontinuation in the NeflgArd trial. However, evidence supporting such extended-duration treatment remains limited.

Methods

In this single-arm retrospective study, patients with primary IgAN and proteinuria ≥0.5 g/24h who received Nefecon for ≥12 months were enrolled. The primary endpoint was the absolute change in estimated glomerular filtration rate (eGFR) from baseline. Secondary endpoints included changes in 24-hour urinary protein, Gd-IgA1, and hematuria.

Results

Seventy-five participants were enrolled. The median treatment duration was 15.7 months (Interquartile range, [IQR]: 12.9, 18.2). The mean daily doses were 14.1 mg (months 0-9), tapering to 8.1 mg (months 12-15). The mean changes in eGFR from baseline were +4.3 mL/min/1.73 m² (95% CI, 2.1 to 6.5; P< 0.001) at month 9, and +1.7 mL/min/1.73 m² (95% CI, -1.8 to 5.6) at month 15. The annualized eGFR slope was +3.2 mL/min/1.73 m²/year (95% CI, 0.6 to 6.0). Proteinuria decreased significantly, with -53.3% at month 9(P < 0.001) and -68.7% at month 15(P < 0.001). The rate of hematuria decreased from 68.0% at baseline to 23.1% at month 15. Gd-IgA1 levels decreased by 30.6% at month 12(P < 0.01). Adverse events were mostly mild (69.3%) with one serious adverse event leading to hospitalization.

Conclusion

In this study, extended treatment with Nefecon for ≥12 months was associated with stabilization of kidney function, substantial reductions in proteinuria, Gd-IgA1 and hematuria, and a favorable safety profile.

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