Dapagliflozin (drug) in Non Alcoholic Fatty Liver Disease Associated Cirrhosis (Liver Disease).

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Age > 18 years <70years

2.Patient with NAFLD associated cirrhosis and moderate ascites

3.Stable eGFR-( more than 60 ml per min per 1.73m2) calculated using MDRD-6 equation:

4.Valid Informed written consent

Exclusion Criteria

1.Hospitalized patients

2.CTP-C patients

3.Intrinsic/structural kidney disease, obstructive uropathy, ADPKD, Anatomic urologic defects that predispose to urinary tract infection

4.History of organ transplantation

5.Refractory Ascites

6.Type 1 DM

7.History of hypoglycemic symptoms in the last 2 months

8.Recurrent UTI

9.Patient with HCC or portal vein thrombosis

10.Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor

11.History of fracture in the preceding year

12.Severe Hyponatremia (Na <125 MEq/L)

13.Pregnancy or Lactating mother

14.Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment

15.MI, unstable angina, stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment

16.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 randomization

17.Mixed ascites (additional etiology of ascites apart from portal hypertension)

18.Any severe extra hepatic condition including respiratory and cardiac failure

19.Acute-on-chronic liver failure as per the APASL criteria

20.Refusal to give consent

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development of CKD at 1 yr defined as per KDIGO guidelines.Timepoint: 1 year

Secondary Outcome Measures

Name	Time	Method
Development of acute kidney disease.Timepoint: 3,6 and 12 months;Development of Chronic Kidney DisaseTimepoint: 3,6,12 months;Discontinuation of the drug due to adverse effectsTimepoint: 1 year;Improvement in eGFR at 3 months.Timepoint: 3,6 and 12 months;Resolution of ascites - partial or completeTimepoint: 3,6 and 12 months