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.

Sponsor
Institute of Liver and Biliary Sciences, India
Study ID
NCT07585526
Status
Not Yet Recruiting

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Conditions

  • Chronic Kidney Diseases
  • MASLD

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Finerenone — DRUG
    finerenone 5 mg/day followed by 10 mg/day. Dose will be increased as necessary up to 20mg/day.
  • Spironolactone — DRUG
    Spironolactone 50mg/day followed by 100mg/day,Dose will be increased as necessary up to 200mg/day.
  • Standard Medical Treatment — OTHER
    1. Salt restricted diet, high protein diet 2. Patient education 3. Use of loop diuretics as indicated and tolerated 4. Glycemic control in diabetic subjects- SGLT2 inhibitors/DPP4 inhibitors/ GLP-1 analog +/- insulin 5. Managing complications of liver disease 6. Albumin infusions as and when required as per physician's discretion. 7. Use of Beta blockers as indicated and tolerated.

Study Details

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 Dates

Start date
Apr 15, 2026
Status verified
Mar 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Finerenone+SMT
    finerenone 5 mg/day followed by 10 mg/day. Dose will be increased as necessary up to 20mg/day + SMT.
  • Active Comparator: Spironolactone+SMT
    Spironolactone 50mg/day followed by 100mg/day,Dose will be increased as necessary up to 200mg/day + SMT.

Primary Outcome Measure

Incidence of chronic kidney disease (CKD) in patients with MASLD/NAFLD related cirrhosis with clinical ascites at 6 months between both the groups, defined as: [ Time Frame: 6 months ]

Central Contacts

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