Abstract
BackgroundDiabetic kidney disease (DKD) is a serious complication associated with diabetes mellitus and can cause end-stage renal disease (ESRD). Traditional Chinese medicine (TCM) is widely used in China to treat DKD, and in particular microalbuminuria and macroalbuminuria. This study will address the efficacy and safety of Shenzhuo Formula (SZF), a frequently prescribed TCM, in DKD patients with macroalbuminuria.Methods/designThis study is a 24-week, randomized, multi-center, double-blinded, double-dummy, controlled, clinical trial that will include 120 DKD patients aged 18 to 80 years old with a 24-h urinary protein (24-h UP) level of between 0.5 g and 3 g and serum creatinine (SCr) ≤ 133 μmol/L (1.5 mg/dL) and compare SZF to irbesartan. The 24-h UP change from baseline to week 24 will represent the primary endpoint with secondary endpoints including SCr, estimated glomerular filtration rate (eGFR), TCM symptoms, urinary albumin excretion rate (UAER), etc. Safety assessments will also be evaluated.DiscussionThis study will provide initial evidence regarding the efficacy and safety of SZF relative to irbesartan in the treatment of DKD patients with macroalbuminuria.Trial registrationChinese Clinical Trial Registry, ID: ChiCTR-ICR-15006311. Registered on 15 April 2015.
Highlights
Diabetic kidney disease (DKD) is a serious complication associated with diabetes mellitus and can cause end-stage renal disease (ESRD)
Shenzhuo Formula (SZF) was used to treat 63 DKD patients with microalbuminuria, and the results showed that after intervention for 3 months and 6 months, microalbuminuria decreased in 92.1% and 90.5% of patients, respectively
The investigator will tell patients that they have the right to withdraw from the trial and they will be provided with standardized treatment to ensure their safety under the following circumstances: (1) rapidly decreasing estimated glomerular filtration rate (eGFR) to less than 30; or Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) twice higher than the normal limits; or serum creatinine (SCr) beyond the normal range after 4 weeks of treatment; (2) development of severe complications or exacerbation of an existing health condition; (3) poor compliance by participants, such as actual drug usage is less than 80% or more than 120% of the prescribed dose; and (4) use of proscribed drugs during the study
Summary
Traditional Chinese Medicine is a valuable medical treatment that still serves the Chinese population today. SZF has shown a promising effect in the treatment of DKD [1] and is usually prescribed to treat DKD patients with the common syndrome pattern of deficiency in qi and with blood stasis. We undertake this trial to examine the efficacy and safety of SZF in relation to irbesartan for the treatment of DKD. Abbreviations 2-h PG: 2-h postprandial plasma glucose;; AEs: Adverse events; ALP: Alkaline phosphatase; ALT: Alanine aminotransferase; AST: Aspartate aminotransferase; BUN: Blood urea nitrogen; DM: Diabetes mellitus; ECG: Electrocardiogram; eGFR: Estimated glomerular filtration rate; ESRD: End-stage renal disease; FBG: Fasting blood glucose; GGT: gamma-glutamyl transferase; HbA1c: Glycosylated hemoglobin; HDL-C: High-density lipoprotein cholesterol; LDL-C: Low-density lipoprotein cholesterol; SCr: Serum creatinine; SOPs: Standard operating procedures; TBIL: Total bilirubin; TC: Total cholesterol; TCM: Traditional Chinese medicine; TG: Triglycerides; UA: Uric acid; UAER: Urinary albumin excretion rate
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