Kidney Week

Abstract: FR-PO0936

Budesonide Delayed-Release Capsules (Nefecon) for IgAN in Pediatric Patients: A Pilot Study

Session Information

• Pediatric Nephrology: Genetic Diseases, Development, Neonatal Nephrology, Glomerular Diseases, and More
  October 23, 2026 | Location: Exhibit Hall A, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Pediatric Nephrology

• 1800 Pediatric Nephrology

Authors

• Han, Yanxinli, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China

Yanxinli Han

• Liu, Yaping, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China

Yaping Liu, PhD

• Yang, Fengjie, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China

Fengjie Yang, PhD

• Wang, Zhimin, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China

Zhimin Wang, APN

• Zhou, Jianhua, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China

Jianhua Zhou, MD

• Zhang, Yu, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China

Yu Zhang, PhD

Background

Nefecon, a targeted-release budesonide for treating gut-associated lymphoid tissue at Peyer’s patches (the principal site of Gd-IgA1 production), has been approved for the treatment of adult IgA nephropathy (IgAN) worldwide. However, evidence regarding its efficacy and safety in pediatric patients with IgAN remains limited.

Methods

In this real-world study, pediatric IgAN patients who initiated Nefecon therapy between January 2025 to July 2025 were included. All patients had an estimated glomerular filtration rate (eGFR) >60 mL/min/1.73 m², persistent hematuria and/or proteinuria. Renal remission was assessed according to the International Pediatric Nephrology Association (IPNA) clinical practice guidelines for IgA nephropathy.

Results

Nine pediatric IgAN patients (6 males, 3 females, median age 12 years) were analyzed. At baseline, four patients (44.4%) had a UPCR >200 mg/g. Treated with Nefecon resulted in rapid and sustained reductions in proteinuria among these four patients: mean UPCR decreased by 59.4% at month 1 (349.7 mg/g vs 178.1 mg/g), 60.5% at month 3 (349.7 mg/g vs 134.2 mg/g), 62.9% at month 6 (349.7 mg/g vs 168.6 mg/g) and 78.1% at month 9 (349.7 mg/g vs 88.75 mg/g). Similarly, the mean URBC declined by 58.9% at month 1 (564.6 /µL vs 130.7 /µL), 81.3% at month 3 (564.6 /µL vs 75.1 /µL) and 90.7% at month 6 (564.6 /µL vs 33.7 /µL). At month 9, the median URBC was 22.5 /µL (IQR: 10.3–227.9) with a mean percentage reduction of 91.4% (95% CI: -0.96 to -0.86). Concurrently, the mean estimated glomerular filtration rate (eGFR) increased modestly to 131.5±15.88 ml/min/1.73 m² with a mean relative increase of 2.7% (95% CI: -0.08 to 0.14). By month 9, 7 patients (77.8%) had achieved complete remission and 2 patients acheived proteinuria (partial) remission (22.2%). Notably, no severe adverse events were reported during the 9-month treatment period.

Conclusion

This real-world study in pediatric IgAN reveals that Nefecon induces substantial and progressive reductions in both proteinuria and hematuria in this population. Moreover, Nefecon is safe and well tolerated, with no severe adverse events observed. Nevertheless, vigilant monitoring for hypothalamic–pituitary–adrenal (HPA) axis suppression remains clinically warranted.