A head-to-head study comparing the efficacy and safety of Tripterygium wilfordii polyglycosides and dagligosim in the treatment of diabetic nephropathy (prospective, randomized, single-center, open, paral

Phase 4

Recruiting

Conditions: diabetic nephropathy

Registration Number: ITMCTR2200005660

Lead Sponsor: Yijishan Hospital of Wannan Medical College

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Voluntarily sign the informed consent before the start of the activities related to this trial, understand the procedures and methods of this trial, and be willing to strictly abide by the clinical trial protocol to complete this trial;
2. 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;
3. 5% = HbA1c = 9.5% at screening and 5% = HbA1c = 9.0% at random
4. 100 = SBP < 160mmhg and 60 = DBP < 100mmhg at random;
5. The EGFR was greater than or equal to 30ml / min / 1.73m 2 at screening and random. EGFR was calculated by cdk-epi formula, and the random proportion of CKD3 and CKD2+1 was 60% : 40%.
6. Urine routine PRO+ or above before screening and at randomization ,Urinary protein = 0.5g/24h or ACR = 300mg / g before screening and at random;
7. Prior to screening, irbesartan basal treatment was =0.15g/d or reached the maximum tolerated dose and remained stable for at least 4 weeks. For less than 0.15g, the reason for intolerance should be explained, such as hypotension or excessive side effects of the drug, or eGFR decline rate: over 30% within 4 weeks.
8.Did not take any renal therapy drugs during the 4 weeks prior to screening, including: Bellingcapsule, Huangkui capsule, Jinshuibao, Iicai, dagalizin, tripterygium wilfordii, and other immunosuppressive drugs, such as leflunomide, hydroxychloroquine, and glucocorticoid preparations.
9. There was no gender limit in the screening, the age was 30-80 years old;
10. Screening BMI:19-35kgm2 (including both ends)

Exclusion Criteria

1. SGLT2 inhibitors were used within 2 weeks;
2. Participated in the clinical trials of any drug or medical device within 3 months, and received the research drug
Intervention of objects or devices;
3. The researchers suspected that the subjects might be allergic or intolerant to the study drug.
4. History or evidence of any of the following diseases before randomization:
1) Previous medical history or clinical evidence suggest non-diabetic kidney disease;
2) History of kidney disease or chronic dialysis or kidney transplantation requiring immunosuppressive therapy;
3) Acute diabetic complications (diabetic ketoacidosis, lactic acidosis, hypertonic nonketotic diabetic coma) occurred within 3 months;
4) Within 3 months, the patients had decompensated heart failure (NYHA grade IV V), unstable angina pectoris, cerebrovascular accident, myocardial infarction, severe arrhythmia, coronary artery bypass grafting or percutaneous transluminal coronary angioplasty;
5) Major operation or incomplete recovery within 3 months;
6) Malignant tumor of any organ system (except local skin basal cell carcinoma) occurred within 5 years, or malignant tumor occurred 5 years before screening, but the disease is in active stage at present
7) Positive history of HIV antibody and positive history of hepatitis B (big three positive, small three positive);
8) Major liver diseases (acute and chronic hepatitis, cirrhosis) are known;
9) He was complicated with rheumatic immune diseases and was receiving immunomodulatory or suppressive drugs;
10) Urinary tract infection symptoms, or urinary leu2 + and above.
5. Any one of the laboratory indexes met the following criteria
1) Alanine aminotransferase or aspartate aminotransferase > 3.0 × unl or total bilirubin > 2.0 × 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, those 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)
7. 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.