Henagliflozin Delays the Progress of Diabetic Nephropathy Via Regulates Gut-Renal Axis

Launched by QIANFOSHAN HOSPITAL · Sep 3, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called henagliflozin to see if it can help slow down diabetic kidney disease (DKD), which is a serious complication for people with diabetes. DKD can lead to kidney failure, and the trial will look at how henagliflozin affects the gut and kidney connection, known as the gut-renal axis. Researchers believe that improving the balance of good and bad bacteria in the gut might help protect the kidneys and reduce symptoms.

To participate in this study, you need to be between 18 and 65 years old and have a confirmed diagnosis of DKD. You should also be stable on certain medications for at least four weeks prior to joining the trial. However, there are some health conditions that would prevent you from participating, such as severe infections or certain heart and liver problems. If you qualify, you can expect regular check-ups and monitoring while taking the study medication, helping researchers understand its effects on your kidney health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1.18-65 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.
• • 4.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 Criteria:
• • 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.
• • 9.1 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.