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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.

NCT07585526 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-05-13

No results posted yet for this study

Summary

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.

Conditions

  • MASLD
  • Chronic Kidney Diseases

Interventions

DRUG

Finerenone

finerenone 5 mg/day followed by 10 mg/day. Dose will be increased as necessary up to 20mg/day.

DRUG

Spironolactone

Spironolactone 50mg/day followed by 100mg/day,Dose will be increased as necessary up to 200mg/day.

OTHER

Standard Medical Treatment

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.

Sponsors & Collaborators

  • Institute of Liver and Biliary Sciences, India

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-15
Primary Completion
2028-03-31
Completion
2028-03-31

Countries

  • India

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07585526 on ClinicalTrials.gov