Diabetic nephropathy
Conditions
Interventions
Trial group:Standard therapy + Shenzhuo Formula + Finerenone placebo. Participants in the experimental group will receive standard therapy combined with Shenzhuo Formula and finerenone placebo. Standa
Control group:Standard therapy + Finerenone + Shenzhuo Formula placebo. Participants in the control group will receive standard therapy combined with finerenone and Shenzhuo Formula placebo. Standard
Sponsors
Hangzhou Traditional Chinese Medicine Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–75 years; 2. Meets the diagnostic criteria for type 2 diabetes mellitus (T2DM) in Western medicine; 3. Meets the diagnostic criteria for diabetic kidney disease (DKD) in Western medicine; 4. 25 =4 weeks before randomization; 8. Blood potassium level <4.8 mmol/L during patient screening; 9. Subject provides informed consent and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Individuals allergic to the components of Shen Zhuo Fang or spironolactone; 2. Those currently receiving other traditional Chinese medicines or proprietary Chinese medicines with DKD therapeutic effects, or whose medication withdrawal period is less than 2 weeks; 3. Individuals using ACEI/ARB in combination; 4. Individuals simultaneously using other mineralocorticoid receptor antagonists or potassium-sparing diuretics; 5. Individuals concurrently using effective cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors or inducers (treatment must be stopped at least 7 days prior to randomization); 6. Addison's disease; 7. Patients with type 1 diabetes; 8. HbA1c > 10%; 9. Known history (congenital or hereditary kidney disease or autoimmune nephropathy) or clinical evidence indicating non-DKD; 10. Individuals requiring immunosuppressive therapy, with a history of dialysis or kidney transplantation, or kidney disease scheduled for living donor transplantation; 11. Acute renal failure requiring dialysis within 12 weeks prior to screening visit; 12. AST or ALT > 2 times the upper limit of normal at screening, or total bilirubin > 1.5 times the upper limit; 13. Liver function impairment classified as Child-Pugh class C; 14. Symptomatic hypotension or systolic blood pressure 170 mmHg or diastolic BP > 100 mmHg; 16. Chronic heart failure with reduced ejection fraction and persistent symptoms (NYHA class II-IV); 17. Hospitalization within 4 weeks prior to screening visit due to stroke, transient ischemic attack, acute coronary syndrome, or worsening heart failure; 18. Undergoing PCI, CABG, or valve repair/replacement within 4 weeks prior to screening, or scheduled for any of these procedures after randomization; 19. Any other condition or treatment that makes the subject unsuitable for this study, preventing participation throughout the study period (e.g., active malignancy or life expectancy less than 12 months); 20. Currently pregnant, breastfeeding, planning pregnancy, or of childbearing potential not using effective contraception; 21. Participation in another drug clinical trial within 1 month prior to this trial or currently enrolled in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Renal composite endpoint events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cardiovascular composite endpoint events;Change in estimated glomerular filtration rate (eGFR);Change in urine albumin-to-creatinine ratio (UACR);Quality of life score;Traditional Chinese medicine syndrome scoring; | — |
Countries
China
Contacts
Public ContactChen Hongyu
Hangzhou Traditional Chinese Medicine Hospital
Outcome results
None listed