Targeted-Release Budesonide in Chinese Patients with IgA Nephropathy: A Real-World Retrospective Cohort Study.
- 1Department of Nephrology, Hangzhou Traditional Chinese Medicine (TCM) Hospital Affiliated to Zhejiang Chinese Medical University, Hangzhou, People's Republic of China.
- 2Key Laboratory of Precise Prevention and Treatment of Rheumatism Syndrome of Renal Wind Disease, Hangzhou, People's Republic of China.
Abstract
Background
Although the NefIgArd trial demonstrated efficacy of targeted-release budesonide (TRF-budesonide) in IgA nephropathy (IgAN), real-world effectiveness in Chinese patients with advanced or highly active disease remains undefined, and predictors of response are underexplored. We aimed to evaluate the effectiveness of TRF-budesonide in routine Chinese practice and to identify baseline clinical and histopathologic features associated with treatment response.Methods
We conducted a single-center retrospective cohort study of 106 Chinese patients with biopsy-proven IgAN who received TRF-budesonide (16 mg/day) with optimized supportive care for 6 months. The primary endpoint was the percentage change in 24-hour proteinuria from baseline. Subgroup analyses were performed according to baseline clinical features, treatment regimen, and Oxford MEST-C classification.Results
After 6 months of treatment, median proteinuria decreased by 38.77% and urinary red blood cell (uRBC) count by 52.86% (both P < 0.001), while kidney function remained stable, with a modest median eGFR increase of 4.80%; the overall response rate (ORR) was 37.74%. Earlier treatment initiation (<4 years from biopsy) was associated with a higher ORR (53.06% vs 24.56%, P = 0.005) and deeper proteinuria reduction (P = 0.009), and the T0 subgroup showed a numerically larger reduction in proteinuria than the T1+2 subgroup. These subgroup associations were exploratory and were not confirmed after adjustment for baseline differences. Neither ORR nor proteinuria reduction differed significantly between treatment regimens. No major safety events were documented in available records.Conclusion
In this Chinese real-world cohort, TRF-budesonide was associated with reduced proteinuria and hematuria over 6 months, with stable to modestly improved kidney function. Exploratory signals related to treatment timing and Oxford T score require prospective validation before they can guide patient selection.
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BibTeX
@article{yang2026targetedrelease,
title = {{Targeted-Release Budesonide in Chinese Patients with IgA Nephropathy: A Real-World Retrospective Cohort Study.}},
author = {Xinyan Yang and Mengting Luo and Shuman Zhao and Yuan Yuan and Hongyu Chen and Xue Jiang},
journal = {Drug design, development and therapy},
year = {2026},
month = oct,
doi = {10.2147/dddt.s637358},
url = {https://europepmc.org/article/MED/42968938},
note = {CC BY-NC},
}
RIS
TY - JOUR
TI - Targeted-Release Budesonide in Chinese Patients with IgA Nephropathy: A Real-World Retrospective Cohort Study.
AU - Xinyan Yang
AU - Mengting Luo
AU - Shuman Zhao
AU - Yuan Yuan
AU - Hongyu Chen
AU - Xue Jiang
PY - 2026
DA - 2026/10/28
JO - Drug design, development and therapy
DO - 10.2147/dddt.s637358
UR - https://europepmc.org/article/MED/42968938
AB - Background Although the NefIgArd trial demonstrated efficacy of targeted-release budesonide (TRF-budesonide) in IgA nephropathy (IgAN), real-world effectiveness in Chinese patients with advanced or highly active disease remains undefined, and predictors of response are underexplored. We aimed to evaluate the effectiveness of TRF-budesonide in routine Chinese practice and to identify baseline clinical and histopathologic features associated with treatment response.Methods We conducted a single-center retrospective cohort study of 106 Chinese patients with biopsy-proven IgAN who received TRF-budesonide (16 mg/day) with optimized supportive care for 6 months. The primary endpoint was the percentage change in 24-hour proteinuria from baseline. Subgroup analyses were performed according to baseline clinical features, treatment regimen, and Oxford MEST-C classification.Results After 6 months of treatment, median proteinuria decreased by 38.77% and urinary red blood cell (uRBC) count by 52.86% (both P < 0.001), while kidney function remained stable, with a modest median eGFR increase of 4.80%; the overall response rate (ORR) was 37.74%. Earlier treatment initiation (<4 years from biopsy) was associated with a higher ORR (53.06% vs 24.56%, P = 0.005) and deeper proteinuria reduction (P = 0.009), and the T0 subgroup showed a numerically larger reduction in proteinuria than the T1+2 subgroup. These subgroup associations were exploratory and were not confirmed after adjustment for baseline differences. Neither ORR nor proteinuria reduction differed significantly between treatment regimens. No major safety events were documented in available records.Conclusion In this Chinese real-world cohort, TRF-budesonide was associated with reduced proteinuria and hematuria over 6 months, with stable to modestly improved kidney function. Exploratory signals related to treatment timing and Oxford T score require prospective validation before they can guide patient selection.
SN - 1177-8881
ER -