EFFICACY AND SAFETY OF BUDESONIDE DELAYED-RELEASE CAPSULES COMBINED WITH AMBRISENTAN FOR IgA NEPHROPATHY

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EFFICACY AND SAFETY OF BUDESONIDE DELAYED-RELEASE CAPSULES COMBINED WITH AMBRISENTAN FOR IgA NEPHROPATHY

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Co-author 1

Yi Yang 15048136878@163.com The first hospital of Jilin University First Hospital, Nephrology Department Changchun China -

Co-author 2

Ran Zhang zhangran_0818@163.com The first hospital of Jilin University First Hospital, Nephrology Department Changchun China -

Co-author 3

Xiaoxuan Zhao 18222062065@163.com The first hospital of Jilin University First Hospital, Nephrology Department Changchun China -

Co-author 4

Shuxin Yu yushu_xin626@163.com The first hospital of Jilin University First Hospital, Nephrology Department Changchun China -

Co-author 5

Weixia Sun sunwx@jlu.edu.cn The first hospital of Jilin University First Hospital, Nephrology Department Changchun China *

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Introduction

Objective: IgA nephropathy (IgAN) is a mesangioproliferative glomerulonephritis characterized by glomerular mesangial deposition of galactose-deficient IgA1 (Gd-IgA1) immune complexes, and currently lacks specific treatment options. Budesonide delayed-release capsules target the distal ileal mucosal lymphoid tissue, modulating immune responses and reducing Gd-IgA1 production. Ambrisentan, as a highly selective endothelin receptor antagonist, improves glomerular endothelial function and reduces proteinuria. This study aims to prospectively evaluate the efficacy and safety of combining budesonide delayed-release capsules with ambrisentan in the early treatment of IgAN patients at high risk of disease progression.

Methods

Methods: This study enrolled 18 patients with biopsy-proven IgAN at The First Hospital of Jilin University between January 2025 and June 2025, with a baseline 24-hour urinary protein excretion ≥ 0.5 g. On top of the maximum tolerated dose of RAS inhibitors, patients received combined therapy with budesonide delayed-release capsules (16 mg/day) and ambrisentan (5 mg/day) for 12 weeks. The primary efficacy endpoint was the mean absolute and percentage reduction in 24-hour urinary protein from baseline to week 12. Secondary endpoints included changes in estimated glomerular filtration rate (eGFR) and the incidence of adverse events. Subgroup analyses were performed, and Spearman correlation analysis was used to assess the relationship between efficacy and Oxford MEST-C scores.

Results

Urinary Protein Changes: The median 24-hour urinary protein level decreased from 0.964 (IQR 0.773, 2.781) g at baseline to 0.566 (IQR 0.370, 1.102) g post-treatment. The median reduction was 0.614 (IQR 0.332, 1.701) g, with a mean percentage reduction of (48.46 ± 32.54)%. This difference was statistically significant (Z = -3.432, P < 0.001). Renal Function Changes: Patient eGFR remained stable during the treatment period, changing from a baseline median of 76.69 (IQR 52.88, 108.82) ml/min/1.73m² to 65.36 (IQR 49.94, 108.77) ml/min/1.73m² (P > 0.05). Safety: No treatment-related adverse events were reported, and there were no treatment discontinuations due to serious adverse events. Subgroup Analysis: Efficacy was highly consistent across all pre-specified subgroups (age [cut-off 45 years], baseline eGFR [cut-off 60 ml/min/1.73m²], baseline urinary protein [cut-off 2 g/day]). The reduction rate in 24-hour proteinuria was similar, with no statistically significant differences between groups (all P > 0.05). No significant correlation was found between the percentage reduction in urinary protein and any of the Oxford MEST-C pathological scores (all P > 0.05).

Conclusion

Conclusion: This study indicates that the combination of budesonide delayed-release capsules and ambrisentan significantly reduces proteinuria levels in high-risk IgAN patients during early treatment, with stable eGFR and a favorable safety and tolerability profile. Notably, the efficacy achieved with this combination regimen at 3 months was significantly superior to the proteinuria reduction reported with budesonide monotherapy at 3 months (~1.11%) and 9 months (27%) in the NefIgArd Phase III clinical trial. This combination strategy, acting through dual pathways of "immune modulation + endothelial function protection," offers a novel therapeutic approach for IgAN and holds significant clinical promise. A larger randomized controlled trial will be conducted to further validate its long-term efficacy and renoprotective effects.This abstract was also submitted for CCSN 2025 congress.

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