[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580524":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":32,"responsibleParty":46,"collaborators":10,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":50,"sex":56,"minAge":57,"maxAge":10,"enrollmentInfo":58,"targetDuration":61,"studyType":62,"phases":10,"briefSummary":63,"conditions":64,"keywords":10,"overallStatus":35,"whyStopped":10,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Second Affiliated Hospital of Soochow University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Finerenone Treatment Group",null,"All enrolled participants will receive finerenone as an add-on to their existing stable treatment regimen. The dose of finerenone will be adjusted based on eGFR levels at enrollment (10 mg once daily if eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m²; 20 mg once daily if eGFR ≥ 60 mL\u002Fmin\u002F1.73 m²).",[13],"Drug: Finerenone",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Finerenone","Treatment will continue for 48 weeks.",[9],[21],"Angiotensin II Receptor Blockers",[23],{"name":24,"affiliation":25,"role":26},"Xie Ying, Ph.D.","Second Affiliated Hospital of Suzhou University","PRINCIPAL_INVESTIGATOR",[28],{"name":24,"role":29,"phone":30,"phoneExt":10,"email":31},"CONTACT","13962187062","13013883877@126.com",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":10,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":10},"The Second Affiliated Hospital of Suzhou University","RECRUITING","Suzhou","Jiangsu","China","CN",{"type":41,"coordinates":42},"Point",[43,44],120.59538,31.30408,{"lat":44,"lon":43},{"type":47,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100580524","evaluation-of-the-effect-of-finerenone-on-renal-function-in-patients-with-type-2-diabetes-and-chronic-kidney-disease-100580524",false,"NCT06838416","Evaluation of the Effect of Finerenone on Renal Function in Patients With Type 2 Diabetes and Chronic Kidney Disease","Evaluation of the Effect of Finerenone on Renal Function in Patients With Type 2 Diabetes and Chronic Kidney Disease: A Prospective, Single-Arm, Multicenter Clinical Study","KSD-01","Inclusion Criteria:\n\n* Diagnosed with Type 2 diabetes according to the 1999 WHO criteria\n* Aged ≥18 years\n* UACR ≥30 mg\u002Fg and eGFR ≥30 ml\u002Fmin\u002F1.73 m² sustained for over 3 months\n* Stable ARB\u002FACEI treatment for ≥4 weeks prior to enrollment\n* Willing to sign a written informed consent and comply with the study protocol\n\nExclusion Criteria:\n\n* Chronic kidney disease diagnosed before Type 2 diabetes\n* Serum potassium \\>4.8 mmol\u002FL\n* Ineffective blood pressure control at screening (systolic BP ≥160 mmHg and\u002For diastolic BP ≥100 mmHg, average of three measurements in the supine position)\n* HbA1c \\>9%\n* Acute urinary tract infection or conditions affecting urine tests\n* Primary or secondary adrenal insufficiency\n* Use of mineralocorticoid receptor antagonists\n* Use of medications with clear effects on urine protein and eGFR within 4 weeks (except kininogenase)\n* Use of strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, ritonavir, nelfinavir, cobicistat, clarithromycin, telithromycin, nefazodone, carbamazepine)\n* ALT or AST \\>2.5 × ULN, total bilirubin (TBIL) \\>2 × ULN\n* Use of systemic glucocorticoids for more than 7 days within 12 weeks prior to screening, or use of systemic glucocorticoids (intravenous\u002Foral or intra - articular) or need for systemic immunosuppressive treatment within the past 14 days\n* Any organ system cancer within the past 5 years, whether treated or untreated\n* Known pregnancy (positive pregnancy test), breastfeeding, recent plans for conception, or not using adequate contraception\n* Participation in other interventional clinical trials within 3 months prior to screening","ALL","18 Years",{"count":59,"type":60},300,"ESTIMATED","1 Year","OBSERVATIONAL","Research Objectives To evaluate the impact of finerenone on renal function, diabetic complications, and safety in patients with Type 2 diabetes and chronic kidney disease.\n\nStudy Design Type: Prospective, single-arm, multicenter clinical trial. Sample Size: 300 patients. Intervention: Finerenone added to existing treatment regimen (10-20 mg once daily, dose adjusted based on eGFR), for 48 weeks.\n\nData Collection Time Points: Baseline, 4 weeks, 12 weeks, 24 weeks, 36 weeks, and 48 weeks.\n\nPrimary Endpoint: Change in urine albumin-to-creatinine ratio (UACR). Secondary Endpoints: Changes in eGFR, 24-hour urine protein, serum uric acid, retinopathy markers, pulse wave velocity (PWV), ankle-brachial index (ABI), etc.\n\nSafety Endpoints: Changes in serum potassium, sodium, and blood pressure.",[65,66,67],"Type 2 Diabetes Mellitus","Chronic Kidney Disease","Renal Function","2025-04-01",{"date":70,"type":71},"2025-04-04","ACTUAL",{"date":73,"type":71},"2023-11-17",{"date":75,"type":60},"2026-12-31",{"name":5,"class":6},1]