Diabetic kidney disease
Conditions
Interventions
DKD group:none
DKD/Fn group:Finerenone
Sponsors
Shanxi Provincial People' s Hospital,The Shanxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years; 2. According to the ADA 2023 edition diagnostic criteria for diabetic kidney disease, clinical diagnosis is defined as urinary albumin/creatinine ratio (UACR) >= 30 mg/g, or eGFR 30-60 ml/min/1.73 m² for >3 months, combined with diabetic retinopathy; or renal biopsy showing pathological changes consistent with DKD; 3. HbA1c 7.0%-10%; 4. Receiving the maximum tolerated dose of renin-angiotensin system inhibitors for >4 weeks; 5. Type 2 diabetes, chronic kidney disease, antihypertensive and lipid-lowering medications stabilised for >4 weeks; 6. Blood pressure normal or well controlled; 7. Serum potassium <= 5.0 mmol/L before enrollment; 8. Patients in both groups matched for sex, age, and DKD stage; 9. Voluntarily participating in and cooperating with the study and signing informed consent.
Exclusion criteria
Exclusion criteria: 1. Type 1 diabetes, other specific types of diabetes, gestational diabetes; 2. Known severe non-diabetic kidney disease, recent history of acute renal failure requiring dialysis, kidney transplant; 3. Patients with heart failure with reduced ejection fraction classified as NYHA class II-IV or left ventricular ejection fraction =160 mmHg or average seated diastolic blood pressure >=100 mmHg; 6. Patients with Addison's disease; 7. Patients taking the following medications: a. spironolactone, eplerenone, or other mineralocorticoid receptor antagonists, any renin inhibitors, potassium-sparing diuretics; b. potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors or inducers; 8. Known or suspected allergy to nonaliskiren active ingredients or any excipients; 9. Pregnancy/breastfeeding; 10. Other patients deemed unsuitable for this study by the investigator (including but not limited to renal artery stenosis, solitary kidney, or active malignancy).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum creatinine;UACR;Inflammatory Biomarkers(IL-1ß TNFa IL-6);Oxidative stress indicators (SOD 4-HNE, MDA, GSH);Lactate;Tubular injury biomarkers(KIM-1 NGAL);Cardiac function parameters; | — |
Secondary
| Measure | Time frame |
|---|---|
| HbA1c;FBG;Blood lipid;ALB; | — |
Countries
China
Contacts
Public ContactShasha Tian
Shanxi Provincial People' s Hospital,The Shanxi Medical University
Outcome results
None listed