Type 2 diabetes with chronic kidney disease
Conditions
Interventions
Experimental group:Oral Colquhounia root tablets
Sponsors
Peking Uniuersity First Hospital
Eligibility
Sex/Gender
All
Age
30 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age = 30,0.5g/24h, or urinary protein creatinine ratio (UPCR)>0.5g/g and lasting for more than 3 months; 4. eGFR = 30 ml/min · 1.73 m2; 5. Standard treatment stable treatment (medication and dosage fixed before enrollment, treatment period = 3 months).
Exclusion criteria
Exclusion criteria: 1. Have a history of diabetes ketoacidosis or type 1 diabetes; 2. Non diabetes nephropathy caused by secondary glomerular disease and systemic disease or primary glomerular disease confirmed by renal biopsy; 3. Has previously used immunosuppressive therapy or had a history of chronic dialysis or kidney transplantation; Note: Subjects who have a brief history of dialysis in the past and have subsequently withdrawn from dialysis can participate. 4. Uncontrollable hypertension (systolic blood pressure = 180 or diastolic blood pressure = 100mmHg), subjects who have been corrected for 1 week but still do not meet the standard (i.e. subjects who cannot be enrolled due to blood pressure issues should adjust their antihypertensive medication, and be re evaluated in the second week. At the same time, ACEI or ARB drugs need to be stably applied for at least 4 weeks); 5. Hyperkalemia, potassium ion concentration>5.5mmol/L (hyperkalemia and aldosterone receptor antagonists, NSAIDS drugs or ß Subjects who are related to receptor blockers and whose doctors believe that the above drugs can be discontinued can be included; 6. Subjects treated with Tripterygium wilfordii preparation within 2 months; 7. Those with evidence of active infection or the presence of infection foci; 8. An unexplained decrease of over 20% in eGFR within 12 months; 9. Subjects who have experienced acute myocardial infarction, unstable angina, vascular intervention therapy (PCI or CABG), or cerebrovascular events within 12 weeks; 10. For specific liver diseases (such as acute hepatitis, chronic active hepatitis, liver cirrhosis), laboratory tests show that alanine aminotransferase exceeds 2 times the normal upper limit or total bilirubin exceeds 1.5 times the normal upper limit. 11. A history of tumors diagnosed within 5 years (excluding cases such as skin squamous cell carcinoma, basal cell carcinoma, and cervical cancer in situ, or tumors that researchers believe have been cured of malignancy and have a low risk of recurrence); 12. Positive for human immunodeficiency virus (HIV) antibodies; 13. Those who have a history of surgery within the past 12 weeks or have not yet recovered from surgery; 14. Subjects who have participated or are currently participating in other interventional clinical studies within the past 12 weeks; 15. Preparation for pregnancy, pregnancy, and breastfeeding; 16. Lower than normal white blood cells or platelets with clinical significance 17. Severe respiratory, digestive, hematological, or psychiatric disorders; 18. Any situation where the researcher or sponsor believes that participating in the experiment is not in the best interests of the subjects, or may hinder, restrict, or violate the research protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| After 6 months of treatment, changes in urine protein (UACR) levels were compared with baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in urinary protein (UACR) levels of subjects compared with baseline after 1 and 3 months of treatment;Remission rate of subjects with diabetic nephropathy after 1, 3, 6 months of treatment;eGFR change curve of subjects after 6 months of treatment; | — |
Countries
China
Contacts
Public ContactYang Li
Peking Uniuersity First Hospital
Outcome results
None listed