The Efficacy and Safety of Abelmoschus manihot for Reduction of Microalbuminuria in Patients with Type 2 Diabetes and Diabetic Nephropathy-A Multicenter, Randomized, Open-Label, Parallel-Controlled Clinical Trial

Objective: Huangkui capsule, an extract from the flowers of Abelmoschus Manihot, has been proved clinically effective in improving chronic kidney disease. This study aimed to evaluate the efficacy and safety of Huangkui capsule in patients with stage 3 diabetic nephropathy. Methods: This multicenter, randomized, open-label, parallel-controlled trial was conducted in six hospitals. The inclusion criteria were 30 mg/g ≤ albumin creatinine ratio (ACR) <300 mg/g, eGFR ≥ 60 mL/min/1.73 m2, and type 2 diabetes with glycosylated hemoglobin ≤ 9%. We enrolled 239 patients who were randomly assigned to the two groups in a 1:1 ratio. They were treated with Huangkui capsule 2.15 g three times a day, or losartan potassium tablets 100 mg/day for 24 weeks. The primary outcome was the change in ACR from baseline and the secondary outcome was the change in eGFR. Results: The ACR in the losartan group was 119.47±78.16 mg/g at baseline and 90.51±136.12 mg/g after 24 weeks of treatment, with a decrease of 30.46±134.16 mg/g (P=0.049). In the Huangkui group, the ACR decreased from 121.98±84.31 mg/g to 88.13±76.66 mg/g, with a drop of 31.94±91.66 mg/g (P=0.002). The change in eGFR was -3.58±10.35 mL/min/1.73 m2 and -3.82±13.05 mL/min/1.73 m2 in the losatan and Huangkui groups, respectively. In subgroup analysis of patients with baseline ACR ≥ 100 mg/g, losatan and Huangkui lowered ACR by 56.83 mg/g (P=0.044) and 78.72 mg/g (P<0.001), respectively. There were no significant differences between the two groups (P>0.05). Conclusions: Huangkui capsule significantly reduced ACR of patients with type 2 diabetes and microalbuminuria and is a promising medicine for diabetic nephropathy. Disclosure J. Yin: None. S. Chen: None. L. Wei: None. W. Jia: None. Funding National Natural Science Foundation of China (82070885); Shanghai Municipal Education Commission (20172025); Xuhui Joint Research Projects on Important Diseases (XHLHGG202110)