[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638111":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":36,"locations":45,"responsibleParty":62,"collaborators":27,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":27,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":27,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":27,"overallStatus":84,"whyStopped":27,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Institute of Liver and Biliary Sciences, India","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Finerenone+SMT","EXPERIMENTAL","finerenone 5 mg\u002Fday followed by 10 mg\u002Fday. Dose will be increased as necessary up to 20mg\u002Fday + SMT.",[13,14],"Drug: Finerenone","Other: Standard Medical Treatment",{"label":16,"type":17,"description":18,"interventionNames":19},"Spironolactone+SMT","ACTIVE_COMPARATOR","Spironolactone 50mg\u002Fday followed by 100mg\u002Fday,Dose will be increased as necessary up to 200mg\u002Fday + SMT.",[20,14],"Drug: Spironolactone",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Finerenone","finerenone 5 mg\u002Fday followed by 10 mg\u002Fday. Dose will be increased as necessary up to 20mg\u002Fday.",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Spironolactone","Spironolactone 50mg\u002Fday followed by 100mg\u002Fday,Dose will be increased as necessary up to 200mg\u002Fday.",[16],{"type":6,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Standard Medical Treatment","1. Salt restricted diet, high protein diet\n2. Patient education\n3. Use of loop diuretics as indicated and tolerated\n4. Glycemic control in diabetic subjects- SGLT2 inhibitors\u002FDPP4 inhibitors\u002F GLP-1 analog +\u002F- insulin\n5. Managing complications of liver disease\n6. Albumin infusions as and when required as per physician's discretion.\n7. Use of Beta blockers as indicated and tolerated.",[9,16],[37,42],{"name":38,"role":39,"phone":40,"phoneExt":27,"email":41},"Dr Vakacherla Lohith, MD","CONTACT","01146300000","lohithvakacherla0910@gmail.com",{"name":43,"role":39,"phone":40,"phoneExt":27,"email":44},"Dr Rakhi Maiwall, DM","rakhi_2011@yahoo.co.in",[46],{"facility":47,"status":27,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Institute of Liver and Biliary Sciences","New Delhi","National Capital Territory of Delhi","110070","India","IN",{"type":54,"coordinates":55},"Point",[56,57],77.2148,28.62137,{"lat":57,"lon":56},[60],{"name":61,"role":39,"phone":40,"phoneExt":27,"email":41},"Vakacherla Lohith, MD",{"type":63,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100638111","safety-and-efficacy-of-finerenone-in-metabolic-dysfunction-associated-steatotic-liver-diseasemasldnafld-related-cirrhosis-patients-with-ascites-in-prevention-of-chronic-kidney-disease-100638111",false,"NCT07585526","Safety and Efficacy of Finerenone in Metabolic Dysfunction Associated Steatotic Liver Disease(MASLD\u002FNAFLD) Related Cirrhosis Patients With Ascites in Prevention of Chronic Kidney Disease.","Safety and Efficacy of Finerenone in Metabolic Dysfunction Associated Steatotic Liver Disease(MASLD\u002FNAFLD) Related Cirrhosis Patients With Ascites in Prevention of Chronic Kidney Disease. A Randomized Control Trial.","Inclusion Criteria:\n\n1. Age \\> 18 years \\\u003C80years\n2. Patient of MASLD\u002F NAFLD cirrhosis with clinical ascites\n3. Stable eGFR-(\\>60 ml\u002Fmin\u002F1.73m2) calculated using MDRD-6 equation: eGFR (ml\u002Fmin\u002F1.73 m2) = 170 × (Scr)-0.999 × (Age)-0.176 × (0.762 if patient is female) × (1.180 if black) × (SUN)-0.170 × (Albumin)0.318\n\nExclusion Criteria:\n\n1. Age \\\u003C18 years \\>80 years\n2. K\u002FC\u002FO systemic hypertension.\n3. Coagulopathy- INR \\>2.5\n4. Post TIPS\n5. CTP class C\n6. Any intrinsic\u002Fstructural kidney disease.\n7. Refractory Ascites\n8. Patient with HCC(outside MILAN criteria) or portal vein thrombosis\n9. Pregnancy or Lactating mother\n10. Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment\n11. Patients with anuria, acute renal failure, or Addison's disease\n12. Heart failure (NYHA II to IV)\n13. History of hospitalization for hyperkalaemia or acute renal failure induced by previous aldosterone antagonist treatment\n14. Ongoing drug or alcohol abuse\n15. Uncontrolled type 2 DM ( HbA1C \\> 9)\n16. MI, unstable angina, stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment\n17. Coronary revascularization (percutaneous coronary intervention \\[PCI\\] or coronary artery bypass grafting \\[CABG\\]) or valvular repair\u002Freplacement within 12 weeks prior to enrolment or is planned to undergo any of these procedures after randomisation\n18. Diagnosed Mixed ascites (additional etiology of ascites apart from portal hypertension)\n19. Patients who are on spirinolactone with stable ascites in the past 12 weeks\n20. Refusal to give consent","ALL","18 Years","80 Years",{"count":75,"type":76},160,"ESTIMATED","INTERVENTIONAL",[79],"NA","Renal dysfunction is a frequent and clinically important complication in cirrhosis, and MASLD\u002FNAFLD is associated with increased risk of incident CKD; however, finerenone has not been specifically studied in MASLD-cirrhosis populations despite proven cardiorenal benefits in diabetic CKD. This monocentric, open-label, randomized controlled trial at the Department of Hepatology, ILBS, New Delhi will enroll 160 adults (18-80 years) with MASLD\u002FNAFLD cirrhosis, clinical grade I-II ascites, and stable eGFR ≥60 mL\u002Fmin\u002F1.73 m² (MDRD-6), with key exclusions including CTP class C, refractory ascites, significant coagulopathy, intrinsic kidney disease, recent major cardiovascular events, and other protocol-defined contraindications. Participants will receive standard medical treatment (dietary measures, diuretics as indicated, metabolic control, complication management, albumin\u002Fbeta-blockers as needed) and will be randomized to finerenone (5 mg\u002Fday uptitrated to 10-20 mg\u002Fday) versus spironolactone (50 mg\u002Fday uptitrated to 100-200 mg\u002Fday). The primary endpoint is incident CKD at 6 months , defined as sustained eGFR \\\u003C60 mL\u002Fmin\u002F1.73 m² over 3 months. Secondary endpoints include MAKE\u002FMACE\u002FMALO at 6 months, drug-related adverse events (including hyperkalemia, hyponatremia, hypotension, hyperuricemia), AKI\u002FAKD episodes, renal biomarkers (e.g., cystatin C, UPCR), ascites response, liver severity scores (MELD 3.0\u002FMELD-Na\u002FCTP), and metabolic\u002Finflammatory\u002Fendothelial markers (e.g., HbA1c, HOMA-IR, hsCRP, vWF). Sample size (n=160; 80\u002Farm) is powered to detect an absolute 20% reduction in CKD progression (35% to 15%) with 80% power and 5% alpha (10% dropout), with intention-to-treat analyses including Kaplan-Meier and Cox regression methods.",[82,83],"MASLD","Chronic Kidney Diseases","NOT_YET_RECRUITING","2026-05-09",{"date":87,"type":88},"2026-05-13","ACTUAL",{"date":90,"type":76},"2026-04-15",{"date":92,"type":76},"2028-03-31",{"name":5,"class":6},1]