PK and PD of YG1699 in CKD Patients With Diabetes
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorRenJi Hospital
About this trial
The goal of this clinical trial is to learn PK and PD of YG1699 in patients with diabetes and renal dysfuction.
Participants will:
Take YG1699 or a placebo every day for 8 days. Visit the clinic 7 times for checkups and tests. Keep a diary of their symptoms. Estimate PK data from a single dose of YG1699. Estimate PD data at baseline and the last day.
Eligibility criteria
Qualifiers
Ability to provide informed consent
Male or female patients ,age between 18 and 70 at screening
Meet the diagnostic criteria for diabetic nephropathy, including patients with type 1 or type 2 diabetes;
Fasting blood glucose <11.1 mmol/L, stable on baseline anti-diabetic medication
Disqualifiers
Hypoglycemia occurs more than 2 times in one month
History of ketoacidosis
Patients who are being treated with swiram and digoxin
Patients with acute kidney injury (serum creatinine increased by ≥ 50% within 1 week)
Trial design
Treatments tested in this trial
- YG1699
- Placebo
Treatment groups
20 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov