Dapagliflozin in Non Alcoholic Fatty Liver Disease Associated Cirrhosis and Its Role in Preventing Development of Chronic Kidney Disease.

• Status: Not yet recruiting
• Trial end date: 2024-03-30
• Target enrollment: 0
• Participant gender: All

Summary

The role of Dapagliflozin in the improvement in CKD in both diabetic and non-diabetic patients has been evaluated in the past. SGLT2i have also been found to be beneficial in NAFLD patients in improving the liver function parameters. It is also known that cirrhotic patients are at a higher risk of developing CKD at 1 year when compared to non cirrhotics. With this study we aim to study the role Dapagliflozin in cirrhotic patients in reducing the development of CKD, its impact on cirrhotic cardiomyopathy and its role in improvement of metabolic profile and liver related outcomes.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Liver and Biliary Sciences, India
• Treatments: Dapagliflozin

Criteria

Inclusion Criteria:

• Age > 18 years <70years

• Patient with NAFLD associated cirrhosis and moderate ascites

• Stable eGFR-(>60 ml/min/1.73m2) calculated using MDRD-6 equation: eGFR (ml/min/1.73 m2) = 198 × [serum creatinine (mg/dL)]-0. 858 × [age]-0. 167 × [0.822 if patient is female] × [serum urea nitrogen concentration (mg/dL)]-0.

• Valid Informed written consent

Exclusion Criteria:

• Hospitalized patients

• CTP-C patients

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

• History of organ transplantation

• Refractory Ascites

• Type 1 DM

• History of hypoglycemic symptoms in the last 2 months

• Recurrent UTI

• Patient with HCC or portal vein thrombosis

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

• History of fracture in the preceding year

• Severe Hyponatremia (Na <125 MEq/L)

• Pregnancy or Lactating mother

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

• 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 randomization

• Mixed ascites (additional etiology of ascites apart from portal hypertension)

• Any severe extra hepatic condition including respiratory and cardiac failure

• Acute-on-chronic liver failure as per the APASL criteria

• Refusal to give consent