MO621: Effectiveness of Adjuvant Astragalus for Diabetic Kidney Disease: Interim Analysis of A Pragmatic Randomised Controlled Trial

Abstract

Abstract BACKGROUND AND AIMS More regimens targeting different mechanisms are needed for the residual risk of renal progression among diabetic kidney disease (DKD) patients. Although in vivo and in vitro studies suggested that add-on astragalus, a commonly used Chinese medicine, could retard renal progression in chronic kidney diseases, its effect on DKD is unclear. METHOD This assessor-blind, add-on, randomized, controlled, parallel, pragmatic trial evaluates the effect of 48 weeks of oral astragalus granules on 118 patients with estimated glomerular filtration rate (eGFR) of 30–90 mL/min/1.73 m2 and urinary albumin-to-creatinine ratio (UACR) of 34–565 mg/mmol. Primary endpoints are the changes in eGFR and UACR between baseline and treatment endpoint. Outcomes are analyzed as intention-to-treat by mixed-effect regression models, adjusting the baseline values of quantitative outcomes, allocation, visit and the interaction between allocation and visit. RESULTS Recruitment started in July 2018. Baseline demographics are comparable between groups. The mean age is 67.9 years and 35.6% are female. Baseline eGFR is 58.1 mL/min/1.73 m2 and the geometric mean of the baseline UACR is 124.5 mg/mmol. From the first 60 patients who have completed the 48-week study period, the endpoint eGFR is 56.2 and 52.7 mL/min/1.73 m2 {intergroup difference: 3.4 mL/min/1.73 m2 [95% confidence interval (CI) −0.3–7.1], P = 0.071} after receiving add-on astragalus and standard care alone, respectively. The endpoint UACR is 138.4 and 116.8 mg/mmol [proportional difference: 1.19 (95% CI 0.91–1.54)] after receiving add-on astragalus and standard care alone, respectively. Four patients developed serious adverse events in each arm. The most common adverse events are edema, syncope and hyperkalemia. CONCLUSION Our interim analysis suggests that add-on astragalus treatment has a trend of stabilizing eGFR among DKD patients with macroalbuminuria.