Safety and Efficacy of Finerenone in Metabolic Dysfunction Associated Steatotic Liver Disease(MASLD/NAFLD) Related Cirrhosis Patients With Ascites in Prevention of Chronic Kidney Disease.
Starting soon · Not applicable
Conditions studied: MASLD, Chronic Kidney Diseases
In brief
Renal dysfunction is a frequent and clinically important complication in cirrhosis, and MASLD/NAFLD 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/NAFLD cirrhosis, clinical grade I-II ascites, and stable eGFR ≥60 mL/min/1.73 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/beta-blockers as needed) and will be randomized to finerenone (5 mg/day uptitrated to 10-20 mg/day) versus spironolactone (50 mg/day uptitrated to 100-200 mg/day). The primary endpoint is incident CKD at 6 months , defined as sustained eGFR \<60 mL/min/1.73 m² over 3 months. Secondary endpoints include MAKE/MACE/MALO at 6 months, drug-related adverse events (including hyperkalemia, hyponatremia, hypotension, hyperuricemia), AKI/AKD episodes, renal biomarkers (e.g., cystatin C, UPCR), ascites response, liver severity scores (MELD 3.0/MELD-Na/CTP), and metabolic/inflammatory/endothelial markers (e.g., HbA1c, HOMA-IR, hsCRP, vWF). Sample size (n=160; 80/arm) 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.
Key facts
- Study ID
- NCT07585526
- Run by
- Institute of Liver and Biliary Sciences, India
- People needed
- 160
- Starts
- 2026-04-15
- Expected to finish
- 2028-03-31
- Last updated by the study team
- 2026-05-13
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age > 18 years <80years
- Patient of MASLD/ NAFLD cirrhosis with clinical ascites
- Stable eGFR-(>60 ml/min/1.73m2) calculated using MDRD-6 equation: eGFR (ml/min/1.73 m2) = 170 × (Scr)-0.999 × (Age)-0.176 × (0.762 if patient is female) × (1.180 if black) × (SUN)-0.170 × (Albumin)0.318
You may not qualify if…
- Age <18 years >80 years
- K/C/O systemic hypertension.
- Coagulopathy- INR >2.5
- Post TIPS
- CTP class C
- Any intrinsic/structural kidney disease.
- Refractory Ascites
- Patient with HCC(outside MILAN criteria) or portal vein thrombosis
- Pregnancy or Lactating mother
- Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment
- Patients with anuria, acute renal failure, or Addison's disease
- Heart failure (NYHA II to IV)
- History of hospitalization for hyperkalaemia or acute renal failure induced by previous aldosterone antagonist treatment
- Ongoing drug or alcohol abuse
- Uncontrolled type 2 DM ( HbA1C > 9)
- MI, unstable angina, stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment
- Coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) or valvular repair/replacement within 12 weeks prior to enrolment or is planned to undergo any of these procedures after randomisation
- Diagnosed Mixed ascites (additional etiology of ascites apart from portal hypertension)
- Patients who are on spirinolactone with stable ascites in the past 12 weeks
- Refusal to give consent
Where it is running
- Institute of Liver and Biliary Sciences — New Delhi, National Capital Territory of Delhi, India
Full record on ClinicalTrials.gov
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