PK and PD of YG1699 in CKD Patients With Diabetes

Launched by RENJI HOSPITAL · Oct 17, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a medication called YG1699 to understand how it behaves in the body (pharmacokinetics) and how it affects patients (pharmacodynamics) with diabetes and kidney issues. The study will involve participants who have diabetic nephropathy, a condition where diabetes causes kidney damage. To be eligible, participants need to be between 18 and 70 years old, have stable blood sugar levels, and should not have used certain diabetes medications recently. It's important that they have been on regular hemodialysis for at least three months if they are on that treatment.

If someone joins the study, they will take YG1699 or a placebo (a non-active pill) every day for eight days and will need to visit the clinic seven times for check-ups and tests. Participants will also keep a diary to track any symptoms they experience. This trial is not currently recruiting participants, but it aims to gather important information that could help improve treatment options for people with diabetes and kidney problems in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Ability to provide informed consent
• • 2. Male or female patients ,age between 18 and 70 at screening
• • 3. Meet the diagnostic criteria for diabetic nephropathy, including patients with type 1 or type 2 diabetes;
• • 4. Fasting blood glucose \<11.1 mmol/L, stable on baseline anti-diabetic medication
• • 5. No history of SGLT2i use within the past month
• • 6. Hemodialysis patients must have maintenance hemodialysis for more than 3 months, with 3 sessions per week (limited to HD or HDF treatment), and spKt/V\>1.2 within 6 months
• • 7. The patient has not used glucocorticoids, calcineurin inhibitors (cyclosporine, tacrolimus), etc. that affect blood sugar within the past month before signing the informed consent form
• • 8. The baseline diabetes management medication regimen has been stable within the past 2 weeks.
• Exclusion Criteria:
• • 1. Hypoglycemia occurs more than 2 times in one month
• • 2. History of ketoacidosis
• • 3. Patients who are being treated with swiram and digoxin
• • 4. Patients with acute kidney injury (serum creatinine increased by ≥ 50% within 1 week)
• • 5. Abnormal liver function (ALT \> 3 times the upper limit of normal value)
• • 6. Hemoglobin \< 80g/L or \> 150g/L
• • 7. The blood pressure of patients with recent symptomatic hypotension is lower than 90/60 mmHg
• • 8. There is acute myocardial infarction stroke infection in the past month
• • 9. There is systemic active infection or uncured tumor
• • 10. The dialysis regimen of HD patients included HP treatment
• • 11. Participating in other interventional clinical studies
• • 12. Pregnant or lactating women
• • 13. Other situations that the researcher thinks are not suitable for joining the study