Kidney Week

Abstract: SA-PO149

Randomized Placebo-Controlled Trials of Tangshen Formula in Diabetic Kidney Disease

Session Information

• Diabetic Kidney Disease: Clinical - II
  October 27, 2018 | Location: Exhibit Hall, San Diego Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Diabetic Kidney Disease

• 602 Diabetic Kidney Disease: Clinical

Authors

• Yan, Meihua, China-Japan Friendship Hospital, Beijing, China

Meihua Yan,

• Li, Ping, China-Japan Friendship Hospital, Beijing, China

Ping Li,

Background

Patients with diabetic mellitus are at high risk of progressing into diabetic kidney disease (DKD), which is associated with high morbidity and mortality. Current drug therapies for DKD are not entirely satisfactory. Tangshen Formula (TSF) is a Chinese herbal medicine remedy for DKD based on empirical evidence gleaned from Chinese medicine practitioners.The multinational, randomized, double-blind, placebo controlled trials of TSF Treatment on DKD (TTD)-1 and TTD-2 evaluated the effects of TSF on DKD when added to standard therapy.

Methods

In TTD-1 trial, we randomly assigned 180 DKD patients with mild to moderate disease (urinary albumin excretion rate (UAER) >20 μg/min, and/or 24-hour urinary protein (24h UP) between 0.5 and 2.0 g/d, and estimated glomerular
filtration rate(eGFR) between 60 ml/min and 130 ml/min) to receive either placebo or TSF. In TTD-2 trial, 146 DKD patients with moderate to severe disease (24h UP between 0.5 and 3.5 g/d, and serum creatinine < 265 μmol/L (3 mg/dl) ) to receive either placebo or TSF. Each trial continued intervention for 24 weeks.Primary outcome was urinary protein level, measured by UAER for participants with microalbuminuria, 24h UP for participants with macroalbuminuria. Secondary outcomes included renal function, serum lipids, quality of life, symptoms, and adverse events.

Results

For participants with macroalbuminuria, TSF displayed a statistically significant decrease in 24h UP in TTD-1(TSF −0.21 compared with placebo 0.36g, with a mean difference of −0.57g; 95% CI, −1.05 to −0.09, P=0.024), while no statistically significant difference was found in TTD-2(TSF 0.74 compared with placebo 0.21 g, with a mean difference of 0.55g; 95% CI, -0.03 to 1.13, P=0.111). The eGFR was improved in both trials (TTD-1: TSF 1.96 compared with placebo −7.05 ml/min/1.73m², with a mean difference of 9.01 ml/min/1.73m², 95% CI, −0.10 to 18.13, P=0.031) (TTD2: TSF 4.22 compared with placebo -4.8 ml/min/1.73m², with a mean difference of 7.8 ml/min/1.73m², 95% CI, 2.10 to 12.68, P=0.016).

Other secondary outcomes showed no statistically significant difference between groups or in the incidence of adverse events in both trials.

Conclusion

TSF appears to provide additional benefits in improving eGFR in DKD patients, based on conventional treatments.

Trial Registration
TTD-1:Chinese Clinical Trial Registry ChiCTR-TRC-10000843
TTD-2: ChiCTR-TRC-13003566