Status:
UNKNOWN
Henagliflozin Delays the Progress of Diabetic Nephropathy Via Regulates Gut-Renal Axis
Lead Sponsor:
Qianfoshan Hospital
Conditions:
Diabetic Nephropathies
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Diabetic kidney disease (DKD) is a serious complication of diabetes, and it is also the leading cause of end-stage renal disease (ESRD) in the world. The aggravation of progressive proteinuria and the...
Eligibility Criteria
Inclusion
- 18-65 years old, regardless of gender; 2. It was confirmed as DKD by renal biopsy. 3. It needs to be treated with DKD standard scheme, but it can be adjusted according to needs.
- eGFR\>30ml/min/1.73m2 5.200mg/g\<UACR\<5000mg/g 6. Stabilize the maximum tolerated dose ACEi/ARB ≥4 weeks. 7. Volunteer to participate in the study, understand the significance of this experiment and the indicators to be measured, and sign the informed consent form.
Exclusion
- 1\. Severe infection: there are clinical manifestations such as fever, cough and expectoration, sore throat, abdominal pain, diarrhea, carbuncle and furuncle, and the white blood cell count in blood is beyond the normal range (10× 109/L); 2. Severe hypoproteinemia (albumin \< 20g/L) 3 malnutrition or BMI\<18.5 kg/m2. 4. Hemoglobin \< 60g/L; 5. No full capacity; 6. Severe hypotension (\< 90/60mmhg); 7. Severe hypertension (\> 180/110mmHg). Have used SGLT2i of any kind, dosage and dosage form within 8.6 months or are intolerant of such drugs.
- 1 type diabetes mellitus 10. Patients who have had ketoacidosis, diabetic coma or multiple hypoglycemia episodes in the past.
- 11\. Polycystic kidney disease, lupus nephritis, ANCA- related vasculitis. 12. Immunosuppressant treatment for 6 months or less before enrollment. 13. Severe heart failure (NYHA grade ≧II-III) 14. Other serious heart diseases, such as recent myocardial infarction, persistent atrial fibrillation and valvular heart disease.
- 15 patients with severe liver dysfunction (ALT or AST\>3 times the normal upper limit, or total bilirubin \> 2 times the normal upper limit) 16. Chronic cystitis, or urinary tract infection ≥3 times within 1 year. 17 patients with obvious bleeding tendency or blood system diseases, or patients with bone marrow suppression.
- 18\. Malignant tumor 19. Pregnant women, lactating patients or patients who plan to become pregnant. 20. There are acute or severe systemic infections. 21. The subject is participating in clinical trials of other drugs or medical devices.
- 22\. Any known drug or alcohol dependence, difficulty in understanding the trial protocol, and inability or unwillingness to follow up according to the trial protocol.
- 23\. Moderate and severe cognitive impairment and no long-term fixed guardian. 24. Chronic diarrhea and indigestion 25. Patients that the researcher thinks are not suitable to participate in this trial.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06031389
Start Date
January 1 2024
End Date
December 31 2025
Last Update
September 11 2023
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