Health Condition 1: K746- Other and unspecified cirrhosis ofliver
Conditions
Interventions
Intervention1: Dapagliflozin with Standard Medical treatment: Name:Dapagliflozin
Dose: 5mg followed by 10 mg,
frequency: Once daily
route of administration: Oral
total duration: 1 year
Control Inte
Sponsors
Institute of Liver and Biliary Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age > 18 years 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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Development of CKD at 1 yr defined as per KDIGO guidelines.Timepoint: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDr Rakhi Maiwall
Institute of Liver and Biliary Sciences
Outcome results
None listed