Diabetic kidney disease
Conditions
Interventions
Viliximab treatment group:The treatment group received vericiguat, starting at a dose of 2.5 mg/day, with dose adjustments based on tolerability up to a maximum maintenance dose of no more than 10 mg/
Placebo control group:The control group received a placebo that was visually and taste-wise similar to vericiguat, with the same dosage and administration method.
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.The patient is aged between 18 and 75 years ol; 2.Patients of childbearing age agree to take appropriate contraceptive measures; 3.Type 2 diabetes patients defined by the American diabetes Association. And meet the following criteria: urinary albumin/creatinine ratio (UACR) >= 30mg/g, and estimated glomerular filtration rate (eGFR) between 15-60ml/min/1.73m^2 (lasting for more than 3 months), combined with cardiovascular diseases such as coronary heart disease or heart failure; 4.Able to understand and follow guidance related to research; 5.Sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Known non diabetes kidney disease; 2. Poor blood sugar control, HbA1c>12% during screening period; 3. Uncontrolled hypertension with mean sitting systolic blood pressure (SBP) >= 170 mmHg and mean sitting diastolic blood pressure (DBP) >= 110 mmHg; 1.During the screening period, systolic blood pressure is less than 90mmHg; 2.Stroke, transient ischemic attack, acute coronary syndrome within 30 days; 6. Perform acute kidney failure dialysis within the first 12 weeks of inclusion; 7. Pregnant women, lactating women, and men and women with fertility plans during the trial period; 8. Any other conditions or treatments that make the subjects unsuitable for this study, such as active malignant tumors or other diseases that limit life expectancy to less than 12 months; 9. Individuals with congenital galactose intolerance, lactase deficiency, or glucose galactose malabsorption; 10. Gastroesophageal reflux disease; 11. Severe liver dysfunction (Child Pugh C grade); 12. Allergic to Viliximab or its ingredients; 13. Use other soluble guanylate cyclase (sGC) agonists (such as levocetirizine); 14. Suffering from mental illness or cognitive impairment, unable to comply with research requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24 - hour urine protein quantification;Estimate glomerular filtration rate;Urine Albumin-to-Creatinine Ratio;Urine Total Protein-to-Creatinine Ratio; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of cardiovascular events, including cardiovascular death, non-fatal myocardial infarction, or hospitalization for heart failure.; | — |
Countries
China
Contacts
Public ContactTang Lin
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed