Efficacy and safety of Nefecon, glucocorticoids, or supportive therapyadded to RASi+SGLT2i in IgA nephropathy

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Background: IgAN is the most common primary glomerulonephritis worldwide. Currently, "RASi + SGLT2i" has become the standard basic treatment regimen. Nefecon is an oral budesonide formulation targeting the intestinal mucosa. Methods: and proteinuria >0.5 g/d. The basic treatment group received RASi + SGLT2i, the glucocorticoids group received additional glucocorticoids, and the Nefecon group received 16 mg/d of Nefecon. The treatment lasted for 9 months. The primary endpoint was the change in 24-h urine protein. Results: The 24-h UPro in all three groups decreased significantly from baseline, and there was no statistically significant difference in the reduction among the groups (P = 0.897). The reduction in the Nefecon group (-59.9%) was similar to that of the glucocorticoids group (-46.5%), and it took effect faster (3 months vs. 6 months). The baseline eGFR of the Nefecon group was lower but remained stable during treatment. Clinical remission rate (urine protein reduction ≥50%): the basic treatment group 41.8%, the glucocorticoids group 52.4%, and the Nefecon group 70.0% (P = 0.018), but the baseline urine protein of the Nefecon group was higher, and the results were biased. There was no difference in the incidence of adverse reactions between the Nefecon group and the glucocorticoids group (50.0% vs. 45.2%, P = 0.52), and the infection rates were 5.0% and 9.5% respectively (P > 0.05). However, isolated leukocyte elevation was more common in the Nefecon group (25.0% vs. 9.5%). Conclusion: The effect of RASi + SGLT2i combined with Nefecon in reducing urine protein is similar to that of glucocorticoids, with faster onset and stable renal function. The conclusion is robust after multi-factor correction, but the retrospective design leads to baseline imbalance and limited correction efficacy, which requires verification through a prospective study. Nefecon may be a potential alternative to glucocorticoids, but attention should be paid to the risk of infection during use.

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