Diabetic kidney disease
Conditions
Interventions
Modified Fangji Huangqi Decoction Granules group:Modified Fangji Huangqi Decoction granules
Tripterygium glycosides Tablet Group:Tripterygium glycosides tablets
Placebo group:placebo
Combined intervention group:Tripterygium glycosides tablets + Modified Fangji Huangqi Decoction granules
Sponsors
Zhejiang Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Adult males or females aged 18 years and above; 2) Meet the criteria for type 2 diabetes; 3) Urinary albumin-to-creatinine ratio (ACR) of 30-5000mg/g and estimated glomerular filtration rate (eGFR) of 30-89ml/min (calculated using the CKD-EPI formula); 4) Have been taking the maximum tolerated dose of an ACEI/ARB drug for 4 weeks or longer (excluded if unable to tolerate); 5) Serum potassium <5.0mmol/L; 6) Female participants must have a negative pregnancy test at the screening visit and agree to take strong contraceptive measures during the study; 7) Voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) With non-diabetic nephropathy (including renal artery stenosis obstructive nephropathy and other abnormal renal function caused by non-renal parenchymal injury) 2) HBA1c >12% at screening visit; 3) Patients whose blood creatinine doubled in the past six months 4) Uncontrolled hypertension (blood pressure >160/100 mmHg at screening visit) or hypotension (systolic blood pressure <90mmHg); 5) Other severe diabetic complications and serious major vascular events in the past six months such as cerebral hemorrhage cerebral infarction acute coronary syndrome or chronic heart failure with symptomatic ejection fraction reduction; 6) Have undergone dialysis in the last 12 weeks; 7) Serious infectious diseases have occurred in the last 4 weeks; 8) Any other disease that may make the patient ineligible to participate in the study such as blood diseases malignancies etc. or serious psychological or psychiatric disorders; 9) Pregnant or lactating women; 10) Patients with a history of allergy to the components of the drug in this study; 11) Subjects who are participating in clinical trials of other drugs;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The sole of eGFR change; | — |
Secondary
| Measure | Time frame |
|---|---|
| Renal composite endpoint; | — |
Countries
China
Contacts
Public ContactBin Zhu
Zhejiang Provincial People's Hospital
Outcome results
None listed