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.

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. A Randomized Control Trial.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Kidney Diseases; MASLD
• Intervention / Treatment: Drug: Finerenone; Other: Standard Medical Treatment; Drug: Spironolactone

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr Rakhi Maiwall, DM; Phone Number: 01146300000; Email: rakhi_2011@yahoo.co.in
• Study Contact Backup: Name: Dr Vakacherla Lohith, MD; Phone Number: 01146300000; Email: lohithvakacherla0910@gmail.com

Study Locations

• India
  • National Capital Territory of Delhi
    • New Delhi, National Capital Territory of Delhi, India, 110070
      • Institute of Liver and Biliary Sciences
      • Contact: Vakacherla Lohith, MD; Phone Number: 01146300000; Email: lohithvakacherla0910@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age > 18 years <80years
2. Patient of MASLD/ NAFLD cirrhosis with clinical ascites
3. 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

Exclusion Criteria:

1. Age <18 years >80 years
2. K/C/O systemic hypertension.
3. Coagulopathy- INR >2.5
4. Post TIPS
5. CTP class C
6. Any intrinsic/structural kidney disease.
7. Refractory Ascites
8. Patient with HCC(outside MILAN criteria) or portal vein thrombosis
9. Pregnancy or Lactating mother
10. Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment
11. Patients with anuria, acute renal failure, or Addison's disease
12. Heart failure (NYHA II to IV)
13. History of hospitalization for hyperkalaemia or acute renal failure induced by previous aldosterone antagonist treatment
14. Ongoing drug or alcohol abuse
15. Uncontrolled type 2 DM ( HbA1C > 9)
16. MI, unstable angina, stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment
17. 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
18. Diagnosed Mixed ascites (additional etiology of ascites apart from portal hypertension)
19. Patients who are on spirinolactone with stable ascites in the past 12 weeks
20. Refusal to give consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Finerenone+SMT; finerenone 5 mg/day followed by 10 mg/day. Dose will be increased as necessary up to 20mg/day + SMT.	Drug: Finerenone; finerenone 5 mg/day followed by 10 mg/day. Dose will be increased as necessary up to 20mg/day.; Other: Standard Medical Treatment; Salt restricted diet, high protein diet; Patient education; Use of loop diuretics as indicated and tolerated; Glycemic control in diabetic subjects- SGLT2 inhibitors/DPP4 inhibitors/ GLP-1 analog +/- insulin; Managing complications of liver disease; Albumin infusions as and when required as per physician's discretion.; Use of Beta blockers as indicated and tolerated.
Active Comparator: Spironolactone+SMT; Spironolactone 50mg/day followed by 100mg/day,Dose will be increased as necessary up to 200mg/day + SMT.	Other: Standard Medical Treatment; Salt restricted diet, high protein diet; Patient education; Use of loop diuretics as indicated and tolerated; Glycemic control in diabetic subjects- SGLT2 inhibitors/DPP4 inhibitors/ GLP-1 analog +/- insulin; Managing complications of liver disease; Albumin infusions as and when required as per physician's discretion.; Use of Beta blockers as indicated and tolerated.; Drug: Spironolactone; Spironolactone 50mg/day followed by 100mg/day,Dose will be increased as necessary up to 200mg/day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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:	CKD diagnosis will be based on either of below criteria: Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m² or; ≥30% decline in eGFR from baseline,assessed using the CKD-EPI equation.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of hyperkalemia/hyponatremia/hypotension/hyperuricemia.		6 months
Incidence of Acute Kidney Injury (AKI) - Number and proportion of participants developing Acute Kidney Injury - Based on KDIGO criteria (increase in serum creatinine ≥0.3 mg/dL in 48 hours or ≥1.5× baseline within 7 days) .		6 months
Incidence of Acute Kidney Disease (AKD) - Number and proportion of participants developing Acute Kidney Disease (Kidney dysfunction lasting 7-90 days after AKI or de novo).		6 months
Change in Model for End-Stage Liver Disease Sodium (MELD-Na) score- Mean change from baseline in MELD-Na score.	MELD ranges from 6 to 40	6 months
Change in Child-Turcotte-Pugh (CTP) score - Mean change from baseline in Child-Turcotte-Pugh score	CTP ranges from 5 to 15	6 months
Composite liver decompensation outcome- measured as % participants with ≥1 event, Includes: SBP, variceal bleed, hepatic encephalopathy.		6 months

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: March 30, 2026
• First Submitted That Met QC Criteria: May 9, 2026
• First Posted (Actual): May 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Organic Chemicals; Polycyclic Compounds; Pregnanes; Steroids; Fused-Ring Compounds; Lactones; Pregnenes; Spironolactone; finerenone
• Other Study ID Numbers: ILBS-MASLDCKD-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No