Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07585526

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.

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

MASLD Chronic Disease Chronic Kidney Diseases Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location contact

Vakacherla Lohith, MD

CONTACT

[email protected]

01146300000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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
  • 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.

Primary outcomes

  1. 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

    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.

Secondary outcomes

  1. Incidence of hyperkalemia/hyponatremia/hypotension/hyperuricemia.

    Time frame: 6 months

  2. 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) .

    Time frame: 6 months

  3. 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).

    Time frame: 6 months

  4. Change in Model for End-Stage Liver Disease Sodium (MELD-Na) score- Mean change from baseline in MELD-Na score.

    Time frame: 6 months

    MELD ranges from 6 to 40

  5. Change in Child-Turcotte-Pugh (CTP) score - Mean change from baseline in Child-Turcotte-Pugh score

    Time frame: 6 months

    CTP ranges from 5 to 15

  6. Composite liver decompensation outcome- measured as % participants with ≥1 event, Includes: SBP, variceal bleed, hepatic encephalopathy.

    Time frame: 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Rakhi Maiwall, DM

CONTACT

[email protected]

01146300000

Dr Vakacherla Lohith, MD

CONTACT

[email protected]

01146300000

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Official study title

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.

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 13, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.