[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565953":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":38,"centralContacts":42,"locations":48,"responsibleParty":62,"collaborators":34,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":34,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":34,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":85,"overallStatus":90,"whyStopped":34,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"RenJi Hospital","OTHER",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"eGFR≥30+YG1699","EXPERIMENTAL","patients with eGFR ≥30ml\u002Fmin\u002F1.73M2 will be treated with YG1699 10mg QD for 8 days.",[13],"Drug: YG1699",{"label":15,"type":10,"description":16,"interventionNames":17},"Hemodialysis+YG1699","patients on hemodialysis will be treated with YG1699 10mg QD for 8 days.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"eGFR\u003C20+YG1699","patients with eGFR \\\u003C20ml\u002Fmin\u002F1.73M2 will be treated with YG1699 10mg QD for 8 days.",[13],{"label":23,"type":24,"description":25,"interventionNames":26},"eGFR\u003C20+placebo","PLACEBO_COMPARATOR","patients with eGFR \\\u003C20ml\u002Fmin\u002F1.73M2 will be treated with placebo 10mg QD for 8 days.",[27],"Drug: Placebo",[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","YG1699","10mg qd for 8 days",[15,19,9],null,{"type":30,"name":36,"description":32,"armGroupLabels":37,"otherNames":34},"Placebo",[23],[39],{"name":40,"affiliation":5,"role":41},"Leyi Gu","PRINCIPAL_INVESTIGATOR",[43],{"name":40,"role":44,"phone":45,"phoneExt":46,"email":47},"CONTACT","86-21-58752345","5505","guleyi@aliyun.com",[49],{"facility":50,"status":34,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":34},"Department of nephrology , Renji Hospital, Shanghai Jiao Tong University School of Medicine","Shanghai","Shanghai Municipality","200127","China","CN",{"type":57,"coordinates":58},"Point",[59,60],121.45806,31.22222,{"lat":60,"lon":59},{"type":41,"investigatorFullName":40,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"Professor","100565953","phase-1-pk-and-pd-of-yg1699-in-ckd-patients-with-diabetes-100565953",false,"NCT06648876","PK and PD of YG1699 in CKD Patients With Diabetes","Pharmacokinetic and Pharmacodynamics of YG1699 in Patients With Diabetes and Kidney Dysfunction","Inclusion Criteria:\n\n1. Ability to provide informed consent\n2. Male or female patients ,age between 18 and 70 at screening\n3. Meet the diagnostic criteria for diabetic nephropathy, including patients with type 1 or type 2 diabetes;\n4. Fasting blood glucose \\\u003C11.1 mmol\u002FL, stable on baseline anti-diabetic medication\n5. No history of SGLT2i use within the past month\n6. Hemodialysis patients must have maintenance hemodialysis for more than 3 months, with 3 sessions per week (limited to HD or HDF treatment), and spKt\u002FV\\>1.2 within 6 months\n7. 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\n8. The baseline diabetes management medication regimen has been stable within the past 2 weeks.\n\nExclusion Criteria:\n\n1. Hypoglycemia occurs more than 2 times in one month\n2. History of ketoacidosis\n3. Patients who are being treated with swiram and digoxin\n4. Patients with acute kidney injury (serum creatinine increased by ≥ 50% within 1 week)\n5. Abnormal liver function (ALT \\> 3 times the upper limit of normal value)\n6. Hemoglobin \\\u003C 80g\u002FL or \\> 150g\u002FL\n7. The blood pressure of patients with recent symptomatic hypotension is lower than 90\u002F60 mmHg\n8. There is acute myocardial infarction stroke infection in the past month\n9. There is systemic active infection or uncured tumor\n10. The dialysis regimen of HD patients included HP treatment\n11. Participating in other interventional clinical studies\n12. Pregnant or lactating women\n13. Other situations that the researcher thinks are not suitable for joining the study","ALL","18 Years","70 Years",{"count":75,"type":76},20,"ESTIMATED","INTERVENTIONAL",[79],"PHASE1","The goal of this clinical trial is to learn PK and PD of YG1699 in patients with diabetes and renal dysfuction.\n\nParticipants will:\n\nTake 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.",[82,83,84],"Diabetes","Renal Insufficiency, Chronic","Hemodialysis",[86,87,88,89,82],"PK","PD","SGLT1\u002F2 inhibitor","CKD","NOT_YET_RECRUITING","2024-10-17",{"date":93,"type":94},"2024-10-18","ACTUAL",{"date":96,"type":76},"2024-10-31",{"date":98,"type":76},"2025-10-30",{"name":5,"class":6},1]