Abstract: TH-PO0508
Real-World Effectiveness, Safety, and Response Heterogeneity of Targeted-Release Formulation of Budesonide in Adults with IgAN
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
- Hu, Sujia, Huazhong University of Science and Technology Tongji Medical College, Wuhan, Hubei, China
- Zhao, Xingyang, Huazhong University of Science and Technology Tongji Medical College, Wuhan, Hubei, China
- Ge, Shuwang, Huazhong University of Science and Technology Tongji Medical College, Wuhan, Hubei, China
Background
Randomized trials show Nefecon reduces proteinuria and improves kidney function, but phase III evidence is limited to moderate CKD with higher proteinuria. We evaluated its real-world effectiveness and safety in IgAN adults, including those underrepresented in phase III trials.
Methods
This retrospective cohort study (June 2024–May 2025) of adults with IgAN receiving Nefecon for ≥9 months collected baseline and 3, 6, 9 month data. The primary outcome was change in urinary protein–creatinine ratio (uPCR). Secondary outcomes were changes in eGFR and hematuria . Subgroup analyses were performed by baseline uPCR, CKD stage, time from diagnosis to treatment initiation. Safety was assessed by recording adverse events.
Results
A total of 76 patients were included (mean age 39.8±9.8 years, 53.9% female, baseline eGFR 52.4±24.9 mL/min/1.73 m^2, median uPCR 591.7 [IQR 296.4–1139.7] mg/g, and 76.3% had hematuria). At 9 months, uPCR decreased by 41.9%, eGFR increased by 5.7%, and the proportion without hematuria rose from 23.7% to 48.7%. Significant uPCR reductions were also observed in key subgroups, including CKD G1 (51.8%), CKD G4 (35.6% ) and baseline uPCR <800 mg/g (28.3%). Patients who initiated treatment < 6 months of diagnosis had significant uPCR reduction (50.8%) and eGFR increase (2.5%), whereas later initiators had significant uPCR reduction (28.0%) but no significant change in eGFR. No serious adverse events occurred.
Conclusion
Nefecon showed favorable effectiveness and safety in IgAN, including in subgroups under-represented in phase III trials. Moreover, earlier treatment initiation led to more favorable outcomes.