Secondary analysis of Huangkui capsule in the treatment of IgAN

Abstract Background: IgA nephropathy is the most common primary glomerular disease and an important cause of chronic kidney disease. Previous clinical studies have confirmed that Huangkui capsule could reduce urine protein of IgA nephropathy by 100 mg/d losartan potassium. However,the effect of Huangkui capsule on IgA nephropathy is not clear. Methods: Based on two multicenter, large sample phase IV clinical trials (NCT 02231125; NCT 02231138), eligible IgA nephropathy patients were screened and the related data were extracted for secondary analysis. Patients were grouped according to the baseline urinary protein, glomerular filtration rate, or pathologic characteristics using IgA nephropathy Oxford classification and the curative effect was analyzed. Taking the decrease of urine protein ≥30% after Huangkui capsule 6-month treatment as the effective standard, multiple regression analysis was used to analyze the influencing factors of Huangkui capsule in reducing urinary protein in IgA nephropathy patients. Results: 503 patients with IgA nephropathy were enrolled. The efficacy of Huangkui capsule in reducing urinary protein in patients with baseline 24h urinary protein ≥1.0 g/d or glomerular filtration rate ≥60 ml/min reach the effective standard. 24h baseline urinary protein, body mass index, serum albumin, and serum creatinine were the independent influencing factors of Huangkui capsule in reducing urinary protein, but there was no significant correlation with the baseline pathological characteristics. After 6 months of Huangkui capsule treatment, the decrease rate of urine protein increased by 7.9% for every 100mg increase of 24h urinary protein and 6.7% for every 1g/L increase of ALB, while decreased by 1.1% and 7% respectively, for every 1μmmol/L increase of serum creatinine and 1kg/m 2 increase of body mass index. Conclusion: The effect of Huangkui capsule is influenced by basic urinary protein, body mass index, serum albumin, and serum creatinine in IgA nephropathy patients. Huangkui capsule can effectively reduce urinary protein in patients with baseline urinary protein ≥1.0 g/d or glomerular filtration rate ≥60 ml/min.