Abstract
BackgroundDiabetic kidney disease (DKD) is one of the most important microvascular complications of diabetes, and its prevalence has increased dramatically in the past few decades. DKD is responsible for considerable morbidity and mortality of patients with diabetes. Keluoxin capsule (KLX) is a Chinese patent medicine that has been used in the clinic to control DKD for years. Previous studies have shown that KLX appears to reduce proteinuria, but the study protocols as well as the primary outcome need to be improved. Thus, we aim to evaluate whether losartan potassium combined with KLX is more effective than losartan potassium in DKD treatment and to provide validated evidence for the application of KLX in the treatment of DKD.MethodsWe will conduct a randomized double-blind placebo-controlled multicenter clinical trial. A total of 252 participants diagnosed with DKD recruited from 18 institutions will be randomly allocated to either a losartan potassium plus KLX (n = 126) or a losartan potassium plus placebo group (n = 126). The participants will be administered KLX or placebo in addition to losartan potassium for 24 weeks. The primary outcome measure will be the decline in estimated glomerular filtration rate (eGFR) (ml/min/1.73 m2/year) from baseline within 24 weeks, and the secondary outcomes will be the incidence of serum creatinine doubling, the incidence of end-stage renal disease (ESRD), the proportion of subjects with a progressive decline in eGFR > 30%, the percent change in 24 h urinary total protein (UTP), the change in the urinary albumin/creatinine ratio (UACR), and the total effective rate of the traditional Chinese medicine (TCM) syndrome scale scores. Comparison of the differences in the variables between groups will be performed according to the data revealed by independent t tests, chi-squared tests, Fisher’s exact tests, or Wilcoxon’s tests. All statistical tests will be two-sided, and significance will be considered for p values < 0.05.DiscussionThis study will be the first randomized clinical trial to evaluate the efficacy and safety of KLX versus the placebo for the treatment of patients with DKD. The outcome of this trial will provide a basis for prescribing KLX to patients with DKD.Trial registrationChinese Clinical Trial Registry (www.chictr.org.cn) ChiCTR1900021113. Registered on January 29, 2019.
Highlights
Diabetic kidney disease (DKD) is one of the most important microvascular complications of diabetes, and its prevalence has increased dramatically in the past few decades
DKD accounts for approximately 20% of new dialysis prescriptions [5], and the high medical cost of renal dialysis treatment has created an urgent need for additional therapeutic strategies for DKD [6]
Treatment of DKD mainly focuses on glycemic control, blood pressure reduction, and renin-angiotensin-aldosterone system (RAAS) blockade [23, 24]
Summary
Diabetic kidney disease (DKD) is one of the most important microvascular complications of diabetes, and its prevalence has increased dramatically in the past few decades. DKD accounts for approximately 20% of new dialysis prescriptions [5], and the high medical cost of renal dialysis treatment has created an urgent need for additional therapeutic strategies for DKD [6] Comprehensive measures such as hypoglycemic and antihypertensive treatments have demonstrated beneficial effects in preventing the development of DKD, especially when used at the stage of microalbuminuria, and angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor II blockers (ARBs) reduce the risk of progression of DKD [7,8,9]. A classic angiotensin receptor blocker, is helpful in protecting the kidneys from damage in DKD [10] This drug was recommended on the list of essential medicines of World Health Organization, which included the most effective and safe medications that experts consider necessary in a healthcare system. Combinations of traditional Chinese medicine (TCM) and Western medicine have advantages over Western medicine in delaying the progression of CKD and improving quality of life
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