[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639964":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":27,"locations":36,"responsibleParty":67,"collaborators":11,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":11,"enrollmentInfo":79,"targetDuration":11,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":11,"overallStatus":88,"whyStopped":11,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Shandong Suncadia Medicine Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A, Participants will receive HRS-7535 tablets administered orally","EXPERIMENTAL",null,[13],"Drug: HRS-7535",{"label":15,"type":16,"description":11,"interventionNames":17},"Group B, Participants will receive matching placebo tablets administered orally","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,24],{"type":21,"name":22,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","HRS-7535",[9],{"type":21,"name":25,"description":25,"armGroupLabels":26,"otherNames":11},"Placebo",[15],[28,33],{"name":29,"role":30,"phone":31,"phoneExt":11,"email":32},"Liang Peng","CONTACT","0518-82342973","liang.peng.lp1@hengrui.com",{"name":34,"role":30,"phone":31,"phoneExt":11,"email":35},"Chen Xu","chen.xu@hengrui.com",[37,54],{"facility":38,"status":11,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Tianjin Medical University General Hospital","Tianjin","Tianjin Municipality","300052","China","CN",{"type":45,"coordinates":46},"Point",[47,48],117.17667,39.14222,{"lat":48,"lon":47},[51],{"name":52,"role":53,"phone":11,"phoneExt":11,"email":11},"Ming Liu","PRINCIPAL_INVESTIGATOR",{"facility":55,"status":11,"city":56,"state":57,"zip":58,"country":42,"countryCode":43,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"The First Affiliated Hospital, Zhejiang University School of Medicine","Hangzhou","Zhejiang","310003",{"type":45,"coordinates":60},[61,62],120.16142,30.29365,{"lat":62,"lon":61},[65],{"name":66,"role":53,"phone":11,"phoneExt":11,"email":11},"Jianghua Chen",{"type":68,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100639964","phase-3-renal-efficacy-and-safety-of-the-novel-oral-small-molecule-glp-1ra-hrs-7535-evaluated-in-participants-with-chronic-kidney-disease-100639964",false,"NCT07625774","Renal Efficacy and Safety of the Novel Oral Small-Molecule GLP-1RA HRS-7535 Evaluated in Participants With Chronic Kidney Disease","A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase III Study to Evaluate the Efficacy and Safety of HRS-7535 in Participants With Chronic Kidney Disease","RENEW-CKD","Inclusion Criteria:\n\n1. Male or female subjects, Age ≥ 18 years at the time of signing informed consent;\n2. Clinically diagnosed with chronic kidney disease at screening;\n3. CKD treatment plan consistent with current clinical guidelines or local standard of care;\n4. eGFR ≥ 20 mL\u002Fmin\u002F1.73 m² and UACR meeting protocol-specified criteria at screening and prior to randomization;\n5. Able and willing to provide a written informed consent;\n\nExclusion Criteria:\n\n1. Uncontrolled severe hypertension prior to randomization (systolic blood pressure ≥ 180 mmHg and\u002For diastolic blood pressure ≥ 110 mmHg); or systolic blood pressure \\\u003C 90 mmHg.\n2. Body mass index (BMI) \\\u003C 20 kg\u002Fm² at screening and prior to randomization.\n3. Prior history of renal transplantation, or planned renal transplantation during the trial;\n4. History or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2).\n5. History of acute or chronic pancreatitis, pancreatic injury, acute cholecystitis, or symptomatic\u002Ftreatable gallbladder disease (excluding cholecystectomy recipients);\n6. Occurrence of acute kidney injury or receipt of dialysis treatment within 3 months prior to screening or randomization;\n7. Presence of severe gastrointestinal diseases within 3 months prior to screening or randomization, or a history of major gastrointestinal surgery affecting gastric accommodation or gastric emptying;\n8. Any condition deemed inappropriate for participation in this clinical trial by the investigator.","ALL","18 Years",{"count":80,"type":81},3690,"ESTIMATED","INTERVENTIONAL",[84],"PHASE3","This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group and event-driven phase III clinical trial. The aim of this trial is to confirm the superiority of HRS-7535 over placebo in reducing the risks of renal outcomes and cardiovascular death among participants with chronic kidney disease (CKD) on the basis of standard of care",[87],"Chronic Kidney Disease","NOT_YET_RECRUITING","2026-05-29",{"date":91,"type":92},"2026-06-04","ACTUAL",{"date":94,"type":81},"2026-07",{"date":96,"type":81},"2031-07",{"name":5,"class":6},2]