Type 2 diabetes nephropathy
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. For adult patients who meet the diagnostic criteria for diabetes nephropathy proposed in the Chinese Guidelines for the Prevention and Treatment of diabetes Nephropathy (2021), the diagnostic criteria are as follows: If DM is identified as the cause of kidney damage and other causes of CKD are excluded, at least one of the following conditions can be diagnosed as DKD. 1.1 Excluding interfering factors, in at least 2 out of 3 tests conducted within 3-6 months, the urinary albumin to creatinine ratio (UACR) should be = 30 mg/g or the 24-hour urinary albumin excretion rate (UAER) should be = 30 mg/24 h (= 20 µ g/min); 1.2 Estimated glomerular filtration rate (eGFR)<60 ml · min ?¹ · (1.73 m ²) ?¹ for more than 3 months. 1.3 Renal biopsy conforms to the pathological changes of DKD. 2 . Serum potassium concentration = 5mmol/l and eGFR = 25ml/min/1.73 ? before enrollment; 3 . Able to understand and follow relevant research instructions.
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. Type 1 diabetes, secondary diabetes, diabetes acute complications (diabetes ketoacidosis, etc.) in the last three months; 2. Continuous use of other mineralocorticoid receptor antagonists such as spironolactone and eplerenone, any renin inhibitors, and potassium sparing diuretics; 3. Continuous use of potent cytochrome P450 3A4 inhibitors or inducers; 4. Serious systemic diseases such as heart, liver, kidney, blood, cerebrovascular, active or untreated malignant tumors, mental and psychological disorders, endocrine disorders, etc; 5. has received or plans to receive a kidney transplant; 6. Untreated or poorly controlled hypertension: mean sitting systolic blood pressure = 160mmHg or mean sitting diastolic blood pressure = 100mmHg; 7. Patients with concomitant chronic or acute infections; 8. Known or possibly allergic to non nifedipine active ingredients or any excipients; 9. Breastfeeding women or pregnant women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| urinary albumin/creatinine ratio;24-hour urinary protein ;urinary ß2-microglobulin;interleukin-1ß;interleukin-6; | — |
Secondary
| Measure | Time frame |
|---|---|
| creatinine;serum potassium;glycosylated hemoglobin;blood fat;alanine aminotransferase;aspartate aminotransferase; | — |
Countries
China
Contacts
The First Hospital of Hebei Medical University