Abstract
BackgroundDiabetic kidney disease (DKD) is the main cause of end-stage kidney disease and has become a heavy economic and social burden due to its high prevalence and morbidity. The most effective strategy is that patients with DKD should be diagnosed and treated early. Preliminary studies showed that the Chinese herbal Tangshen Formula (TSF) may delay the progression of DKD, reducing microalbuminuria and macroalbuminuria and improving renal function. We designed a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of TSF in patients with DKD.Methods/designThis trial is a 13-center, randomized, double-blind, placebo-controlled study. A total of 632 participants will be randomized in a 1:1 ratio to an experiment group (TSF plus losartan) and a control group (placebo plus losartan). The trial cycle will last 24 weeks. The primary outcome will be the change in the urine microalbumin–creatinine ratio from baseline to week 24. The secondary outcome will be the change in the rate of progression to the clinical proteinuria period after intervention, the rate of urine microalbumin negative conversion, the rate of normal urinary microalbumin, the doubling rate of the baseline creatinine value and the glomerular filtration rate between the two groups. Safety in medication will also be evaluated.DiscussionWe hypothesize that patients with type 2 diabetes in the early stage of DKD will benefit from TSF. If successful, this study will provide evidence-based recommendations for clinicians.Trial registrationClinicalTrials.gov, NCT03009864. Registered January 2017.
Highlights
Diabetic kidney disease (DKD) is the main cause of end-stage kidney disease and has become a heavy economic and social burden due to its high prevalence and morbidity
We hypothesize that patients with type 2 diabetes in the early stage of DKD will benefit from Tangshen Formula (TSF)
These results showed that the proportion of patients with the albuminto-creatinine ratio (ACR) reduced by 50% or more in the losartan group was 12.5% and the preliminary study of TSF data manifested that TSF as an addon study can improve 50% of patients
Summary
DKD is part of the systemic microangiopathy and glomerular sclerosis caused by diabetes. In European and American countries, DKD is the primary cause of renal replacement therapy, accounting for about 1/2. It is the second common cause of ESRD in China after glomerular disease [1]. Compared to CKD from non-diabetic causes, DKD develops more rapidly into ESRD [34, 35]. Many patients have turned to Chinese herbal medicine for treatment as a complementary and necessary combination-drug therapy for kidney disease in China due to its fewer adverse reactions and more effective interventions. Research from Taiwan has demonstrated that patients with CKD who used CHM had a significantly reduced ESRD risk (60%) [44]. This work has the potential function to delay the development of DKD. Protocol version number 20,160,718 protocol (date 18 October 2016)
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