[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639964":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":16,"studyPopulation":16,"armGroups":38,"interventions":49,"overallOfficials":16,"centralContacts":57,"locations":66,"responsibleParty":97,"collaborators":16,"id":99,"slug":16,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":100,"sex":106,"minAge":107,"maxAge":16,"enrollmentInfo":108,"targetDuration":16,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":16,"overallStatus":117,"whyStopped":16,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Shandong Suncadia Medicine Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"Time to first occurrence of any of the following renal composite endpoint events","1. Death due to renal disease；\n2. Cardiovascular death;\n3. Renal replacement therapy (maintenance dialysis for at least 4 weeks or renal transplantation);\n4. Sustained eGFR \\\u003C 15 mL\u002Fmin\u002F1.73 m² for at least 4 weeks;\n5. Sustained decline of ≥40% in eGFR from baseline for at least 4 weeks;","Up to approximately 4.8 years",[14,18,21,23,25],{"measure":15,"description":16,"timeFrame":17},"Annual rate of change in estimated glomerular filtration rate (eGFR) from baseline to 24 Month of treatment;",null,"From baseline to Month 24",{"measure":19,"description":16,"timeFrame":20},"Percentage change in urine albumin-to-creatinine ratio (UACR) from baseline at Month 9 of treatment;","At Month 9",{"measure":22,"description":16,"timeFrame":20},"Change in systolic blood pressure from baseline at Month 9 of treatment.",{"measure":24,"description":16,"timeFrame":12},"Time to first diagnosis of diabetes for participants without diabetes at baseline;",{"measure":26,"description":16,"timeFrame":12},"Time to first occurrence of any cardiovascular composite endpoint event (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke).",{"allocation":28,"interventionModel":29,"interventionModelDescription":16,"primaryPurpose":30,"observationalModel":16,"timePerspective":16,"maskingInfo":31},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":32,"maskingDescription":16,"whoMasked":33},"QUADRUPLE",[34,35,36,37],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[39,44],{"label":40,"type":41,"description":16,"interventionNames":42},"Group A, Participants will receive HRS-7535 tablets administered orally","EXPERIMENTAL",[43],"Drug: HRS-7535",{"label":45,"type":46,"description":16,"interventionNames":47},"Group B, Participants will receive matching placebo tablets administered orally","PLACEBO_COMPARATOR",[48],"Drug: Placebo",[50,54],{"type":51,"name":52,"description":52,"armGroupLabels":53,"otherNames":16},"DRUG","HRS-7535",[40],{"type":51,"name":55,"description":55,"armGroupLabels":56,"otherNames":16},"Placebo",[45],[58,63],{"name":59,"role":60,"phone":61,"phoneExt":16,"email":62},"Liang Peng","CONTACT","0518-82342973","liang.peng.lp1@hengrui.com",{"name":64,"role":60,"phone":61,"phoneExt":16,"email":65},"Chen Xu","chen.xu@hengrui.com",[67,84],{"facility":68,"status":16,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"Tianjin Medical University General Hospital","Tianjin","Tianjin Municipality","300052","China","CN",{"type":75,"coordinates":76},"Point",[77,78],117.17667,39.14222,{"lat":78,"lon":77},[81],{"name":82,"role":83,"phone":16,"phoneExt":16,"email":16},"Ming Liu","PRINCIPAL_INVESTIGATOR",{"facility":85,"status":16,"city":86,"state":87,"zip":88,"country":72,"countryCode":73,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"The First Affiliated Hospital, Zhejiang University School of Medicine","Hangzhou","Zhejiang","310003",{"type":75,"coordinates":90},[91,92],120.16142,30.29365,{"lat":92,"lon":91},[95],{"name":96,"role":83,"phone":16,"phoneExt":16,"email":16},"Jianghua Chen",{"type":98,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","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":109,"type":110},3690,"ESTIMATED","INTERVENTIONAL",[113],"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",[116],"Chronic Kidney Disease","NOT_YET_RECRUITING","2026-05-29",{"date":120,"type":121},"2026-06-04","ACTUAL",{"date":123,"type":110},"2026-07",{"date":125,"type":110},"2031-07",{"name":5,"class":6},2]