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Kidney Week

Abstract: SA-PO0646

Targeted-Release Budesonide in IgAN: Real-World Efficacy and Safety in a Chinese Cohort

Session Information

Category: Glomerular Diseases

  • 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics

Authors

  • Chen, Xing, Department of Nephrology (Fujian Provincial Clinical Research Center for Glomerular Nephritis), The First Affiliated Hospital of Xiamen University, School of Medicine, Xiamen University, Xiamen, China
  • Wang, Ruopei, Department of Nephrology (Fujian Provincial Clinical Research Center for Glomerular Nephritis), The First Affiliated Hospital of Xiamen University, School of Medicine, Xiamen University, Xiamen, China
  • Wang, Wen, Department of Nephrology (Fujian Provincial Clinical Research Center for Glomerular Nephritis), The First Affiliated Hospital of Xiamen University, School of Medicine, Xiamen University, Xiamen, China
  • Yao, Lijing, Department of Nephrology (Fujian Provincial Clinical Research Center for Glomerular Nephritis), The First Affiliated Hospital of Xiamen University, School of Medicine, Xiamen University, Xiamen, China
  • Zhang, Lu, Department of Nephrology (Fujian Provincial Clinical Research Center for Glomerular Nephritis), The First Affiliated Hospital of Xiamen University, School of Medicine, Xiamen University, Xiamen, China
  • Shao, Leping Shao,, Department of Nephrology (Fujian Provincial Clinical Research Center for Glomerular Nephritis), The First Affiliated Hospital of Xiamen University, School of Medicine, Xiamen University, Xiamen, China
Background

Immunoglobulin A nephropathy (IgAN) is a major cause of progressive kidney failure. Targeted-release budesonide (Nefecon) selectively suppresses pathogenic IgA1 production in gut-associated lymphoid tissue. We evaluated its efficacy and safety in a real-world cohort of Chinese patients with IgAN.

Methods

In this single-center retrospective study, 103 biopsy-proven IgAN patients received Nefecon 16 mg daily and were followed for 1–9 months. Primary assessments included urinary albumin excretion (UAE) and urinary red blood cell (RBC) count. Renal function was evaluated by estimated glomerular filtration rate (eGFR). Longitudinal changes were analyzed using mixed-effects models for repeated measures. Prespecified subgroup analyses were performed according to baseline eGFR strata, pathological grading, baseline therapy, and the proportion of global glomerulosclerosis (GS) on kidney biopsy. Adverse events were systematically collected.

Results

At 9 months, model-estimated UAE declined by 51.4% (from 1285.6 to 625.2 mg), with 64% of patients achieving ≥50% UAE reduction. Urinary RBC decreased by 73.4%, and 50% attained complete hematuria remission. Nefecon was initiated at a median 13.4 months post-IgAN diagnosis. The prior progressive eGFR decline was attenuated, with renal function stabilized after treatment. Subgroup analyses showed significant UAE reductions in patients with GS ≥20%, more prominent improvements in Lee IV–V versus II–III, and better renal outcomes in those with baseline eGFR ≥35 mL/min/1.73 m^2.

Conclusion

In this single-center real-world cohort, Nefecon significantly reduced albuminuria and hematuria and stabilized renal function with favorable safety, supporting its routine targeted use for IgAN.