NCT07585526Not yet recruiting
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.
Source: ClinicalTrials.gov · Last updated 13 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 30 Mar 2026
- Start date
- Apr 2026
- Primary completion date
- Mar 2028
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- NCT number
- NCT07585526
What you commit to
- Study type: Interventional
- Planned participants: 160
- From Apr 2026 to the primary completion date, Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment
- History of hospitalization for hyperkalaemia or acute renal failure induced by previous aldosterone antagonist treatment
- Ongoing drug or alcohol abuse
- 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
Other illness
- K/C/O systemic hypertension.
- Any intrinsic/structural kidney disease.
- Patient with HCC(outside MILAN criteria) or portal vein thrombosis
- Patients with anuria, acute renal failure, or Addison's disease
- Heart failure (NYHA II to IV)
- Diagnosed Mixed ascites (additional etiology of ascites apart from portal hypertension)
Lab values
- Coagulopathy- INR \>2.5
- Uncontrolled type 2 DM ( HbA1C \> 9)
Age
- Age \<18 years \>80 years
Other
- Post TIPS
- CTP class C
- Refractory Ascites
- Pregnancy or Lactating mother
- Patients who are on spirinolactone with stable ascites in the past 12 weeks
- Refusal to give consent
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute of Liver and Biliary Sciences Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.