diabetic nephropathy
Conditions
Interventions
control group:Dapagliflozin 10mg qd
treatment group:Tripterygium glycosidesin combination with Dapagliflozin
Sponsors
Yijishan Hospital of Wannan Medical College
Eligibility
Sex/Gender
All
Age
20 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. They met the diagnostic criteria of diabetic nephropathy. They had received renal biopsy within 6 months, and the pathological diagnosis was consistent with DN, or the clinical diagnosis was consistent with DN although they did not receive renal biopsy; 2. Patients who were treated with dapagliflozin prior to screening but had poor efficacy control (subjects with random urinary PRO 1+ and above, or random urinary UACR > 300 mg/g (> 35.0 mg/mmol) or urinary protein quantification > 0.5 g/24h); 3. No contraindications to drug use; 4. Informed patients and their families.
Exclusion criteria
Exclusion criteria: 1. Participated in the clinical trials of any drug or medical device within 3 months, and received the research drug Intervention of objects or devices; 2. Persons with severe vital organ dysfunction; 3. Persons of childbearing age with pregnancy requirements (within one year), pregnant and lactating women; 4. Known major liver disease (acute and chronic hepatitis, cirrhosis).5.Any one of the laboratory indexes met the following criteria (1) Alanine aminotransferase or aspartate aminotransferase > 3.0 x unl or total bilirubin > 2.0 x unl (2) Blood potassium > 5.5mmol/l; 3) Albumin < 25g / L; 4) Hb is less than 90g; 5. Urine routine examination showed Leu 2 + and above. 6. Children, of childbearing age who have pregnancy requirements (within one year), pregnant women, and lactating women. The subjects are employees of the research center or have affiliation with the employees of the research center participating in the implementation of this study (current legal spouse, parents, children, siblings); 6. The researcher believes that the patient has any factors (medical, psychological, social, or geographical factors) that may affect the efficacy and safety evaluation of the study or cause the patient to fail to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urinary Albumin To Creatinine Ratio(UACR);24h-pro;ß2-MG;Serum creatinine(Scr);Blood Urea Nitrogen(BUN);Albumin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Interleukin(IL);TNF-a;C-reactiveprotein(CRP);Cystatin-C; | — |
Countries
China
Contacts
Public ContactJialin Gao
Outcome results
None listed