Health Condition 1: N181- Chronic kidney disease, stage 1 Health Condition 2: K760- Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
Intervention1: Finerenone with SMT: finerenone 5 mg per day followed by 10 mg per day. Dose will
be increased as necessary up to 20mg per day with SMT.
Duration: 6 months
Control Intervention1: Spiron
Sponsors
Institute of Liver and Biliary Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient of MASLD or NAFLD cirrhosis with clinical ascites. 2. Stable eGFR (more than 60 ml per min per 1.73m2) calculated using MDRD 6 equation.
Exclusion criteria
Exclusion criteria: 1. Age less than 18 years or more than 80 years 2. Known case of systemic hypertension 3. Coagulopathy INR more than 2.5 4. Post TIPS 5. CTP class C 6. Any intrinsic or 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 Addisons disease 12. Heart failure NYHA class 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 diabetes mellitus HbA1c more than 9 16. Myocardial infarction unstable angina stroke or transient ischemic attack within 12 weeks prior to enrolment 17. Coronary revascularization percutaneous coronary intervention or coronary artery bypass grafting or valvular repair or replacement within 12 weeks prior to enrolment or planned after randomisation 18. Diagnosed mixed ascites additional etiology apart from portal hypertension 19. Patients on spironolactone with stable ascites in the past 12 weeks 20. Refusal to give consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To study the efficacy of Finerenone in preventing development of chronic kidney disease at 6 months in patients with MASLD/NAFLD related cirrhosis with clinical ascites.Timepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of hyperkalemia/hyponatremia/hypotension/hyperuricemia.Timepoint: 6 months;Impact on renal reserve and kidney functions - assessed by decline in eGFR, no of AKI episodes, AKD, progression to CKD, biomarkers of renal injury - cystatin C, UPCR, kidney biopsy in patients developing CKD (wherever feasible)Timepoint: 6 months;Impact on liver related outcomes - assessed by control of ascites, improvement in liver severity scores - MELD 3.0, MELD Na, CTP, incidence of complications( SBP, Variceal bleed, hepatic encephalopathy)Timepoint: 6 months;Impact on metabolic profile - assessed by HbA1C levels, S.HDL, S.TG, fasting blood sugar, blood pressure, BMI, HOMA IR, HS CRP.Timepoint: 6 months;Impact on inflammatory biomarkers and markers of endothelial dysfunction . (vWF- VITRO Score).Timepoint: 6 months | — |
Countries
India
Contacts
Public ContactDr Rakhi Maiwall
Institute of Liver and Biliary Sciences
Outcome results
None listed