Diabetic kidney disease
Conditions
Interventions
TQF group:Tangshen Qushi Formula (TQF) plus usual care
Placebo group:Placebo plus usual care
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged 18 years and over; 2. Confirm to the diagnostic criteria of diabetic kidney disease; 3. eGFR less than 90 (excluded) mL/min/1.73m2 and no less than 15 (included) and (calculated by CKD-EPI equation) and the change of eGFR within the latest 12 weeks before inclusion less than 30%; 4. Urinary protein creatinine ratio less than 3500 mg/g; 5. Agree to make themselves available for the period of the study; 6. provide written informed consent. American Diabetes Association (ADA) recommends DKD is diagnosed based on a clear history of diabetes and a causal relationship with changes in urinary protein and renal function after excluding other primary and secondary glomerular diseases and systemic diseases. Besides, diagnosis of DKD should meet at least one of the following criteria in KDIGO guideline: (1) Urinary albumin-to-creatinine ratio >= 30 mg/g or urinary albumin excretion rate >= 30 mg/24h, and UACR or UAER are repeated within 3 to 6 months, and 2 out of 3 times reached or exceeded the critical value after eliminating infection and other interfering factors; (2) Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m2; (3) Renal biopsy was consistent with DKD pathological changes.
Exclusion criteria
Exclusion criteria: 1. History of maintenance dialysis treatment or kidney transplantation for at least 90 days; 2. Plan to accept maintenance dialysis treatment or kidney transplantation within 2 weeks; 3. Diagnosed with Acute urinary tract infection within 2 weeks before randomisation; 4. Diagnosed with other primary chronic kidney diseases (such as glomerulonephritis, chronic pyelonephritis, ischemic kidney disease, etc.) and the average eGFR decreased by more than 30% within 12 weeks before enrolment; 5. History of abnormal liver function (AST or ALT or alkaline phosphatase > 3 TIMES ULN), or other known acute and chronic active hepatitis, cirrhosis; 6. History of Acute coronary syndrome, heart failure (NYHA grade III-IV), or acute myocardial infarction, unstable angina, stroke, or any other cardiovascular or cerebrovascular accident requiring revascularisation surgery within 12 weeks prior to enrolment, or a revascularisation operation is urgently needed after recruitment; 7. History of severe acute diabetic complications include but not limit to ketoacidosis, lactic acidosis, hyperotonic non-ketotic diabetic coma, hypoglycemic coma occurred within 24 weeks before screening; 8. History of active malignant tumor disease within 5 years prior to screening; 9. History of mental illness or language barrier before screening and are unable or unwilling to cooperate; 10. History of autoimmune diseases (for example, systemic lupus erythematosus) and are receiving hormone or immunosuppressive therapy before screening; 11. Be allergic to any medications or ingredients Astragalus membranaceus, Salt dodder, Blanched peach kernel, Atractylodes, Tangerine Peel, Centella asiatica, Cicada Flower; Or intolerance to these medications or ingredients (e.g. lactose intolerance); 12. Participate in other clinical trials or have participated in trials of other drugs within 12 weeks prior to screening (refer to those who are enrolled and receiving trial drugs); 13. Female during pregnancy or lactation; 14. Other conditions that the investigator judged inappropriate for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| eGFR slope; | — |
Secondary
| Measure | Time frame |
|---|---|
| Urinary albumin creatinine ratio;Urinary protein creatinine ratio;Renal function set (serum creatinine, blood urea nitrogen, serum uric acid, serum albumin);HbA1c%;Blood lipids profile (triglycerides, cholesterol, high- and low-density lipoprotein cholesterol);Score of dampness syndrome scale of Chinese medicine;The survival time of renal composite endpoint events; | — |
Countries
China
Contacts
Public ContactXusheng Liu
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed