Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT05849220
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05849220
Study Brief:
Protocol Section:
NCT05849220