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Abstract: SA-PO0636

Targeted-Release Budesonide (Nefecon) in Patients with Primary IgAN and Proteinuria 0.5-1.0 g/day: Real-World Efficacy and Safety

Session Information

Category: Glomerular Diseases

  • 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics

Author

  • Rong, Shu, Shanghai General Hospital, Shanghai, China
Background

The 2025 KDIGO guidelines indicates that IgA nephropathy (IgAN) with persistent proteinuria ≥0.5 g/d carries significant risk of progression.Although NefIgArd demonstrated benefit of Nefecon in patients with proteinuria ≥1 g/d,data are limited for those with proteinuria 0.5–1.0 g/d; we therefore evaluated the real-world efficacy and safety of Nefecon in this subgroup.

Methods

Single-center retrospective analysis included adults with biopsy-proven primary IgAN and baseline UTP 0.5–1.0 g/d treated with Nefecon.Baseline demographics,laboratory parameters(UTP, eGFR, uric acid, albumin, urine sediment red blood cells),Oxford histologic classifications,and concomitant medications were collected.Changes in UTP and eGFR during follow-up were assessed.Safety endpoints included adverse events (AEs).

Results

7 patients were enrolled (4 male [57.1%],all newly diagnosed;median age at renal biopsy and at treatment initiation was 31.0 years (IQR 27.5–38.0).Baseline median UTP was 0.67 g/d (IQR 0.56–0.94),median eGFR 89.0 mL/min/1.73m2 (IQR 81.5–107.0), median urine sediment RBC 105.0/μL (IQR 64.0–260.0). Histology:M1 85.7%, S1 85.7%, T1 42.9%, E1 14.3%, C1 14.3%. Concomitant treatments: RASI 85.7%, SGLT2i 28.6%, hydroxychloroquine 71.4%. Median treatment duration was 8.5 months (maximum 12 months).
By month 9, median UTP decreased from 0.67 g/d (IQR 0.56–0.94) to 0.20 g/d (IQR 0.17–0.21), corresponding to a 70.1% reduction from baseline. Four patients achieved UTP <0.3 g/d. Median eGFR increased to 101.0 mL/min/1.73m2 with no progressive decline.6 patients experienced mild-to-moderate AEs that resolved with symptomatic management; no serious AEs occurred.

Conclusion

In primary IgAN patients with baseline proteinuria 0.5–1.0 g/d,Nefecon showed substantial proteinuria reduction and renal function stabilization with a favorable safety profile.Early intervention targeting gut-associated immune mechanisms,with treatment initiated upon diagnosis, may benefit IgAN patients at intermediate proteinuric risk who fall below conventional high-risk thresholds. Larger prospective controlled studies are warranted to confirm long-term efficacy and optimize clinical management strategies.