An Exploratory Study on the Efficacy and Safety of Short-Term Empagliflozin Administration for Cirrhotic Ascites Resistant to Standard Diuretic Therapy
An Exploratory Study of novel diuretic therapy for cirrhotic ascites
Tateishi Ryosuke
The University of Tokyo Hospital
7-3-1 Hongo. Bunkyo-ku
+81-338155411
ryo.tate@gmail.com
Okushin Kazuya
The University of Tokyo Hospital
7-3-1 Hongo. Bunkyo-ku
+81-338155411
kazuyaoxin@g.ecc.u-tokyo.ac.jp
Recruiting
Mar. 09, 2026
10
Interventional
single arm study
open(masking not used)
uncontrolled control
single assignment
treatment purpose
(1) Patients diagnosed with liver cirrhosis
(2) Patients diagnosed with Type 2 diabetes mellitus
(3) Patients with poor ascites control despite appropriate administration of standard diuretic therapy (spironolactone and furosemide) for 7 days or more
(4) Patients who refuse inpatient induction of tolvaptan based on patient preference
(5) Patients with eGFR >= 45 mL/min/1.73 m^2
(6) Patients with serum sodium levels >= 130 mmol/L
(7) Patients with Child-Pugh classification B and MELD-Na score >= 15
(8) Patients with mean blood pressure >= 75 mmHg, or systolic blood pressure >= 100 mmHg
(9) Patients aged >= 18 years and < 85 years at the time of obtaining consent
(10) Gender is not limited (Any gender)
(11) Patients who have provided written informed consent of their own free will after receiving a full explanation regarding participation in this study and fully understanding it
(12) Patients capable of outpatient visits according to the study schedule
(1) Patients with portal vein thrombosis
(2) Patients with untreatable hepatocellular carcinoma
(3) Patients who presented with gastrointestinal bleeding within 2 weeks
(4) Patients who presented with overt hepatic encephalopathy within 4 weeks
(5) Patients who initiated, changed the dose of, or discontinued glucose-lowering agents (including insulin) within 4 weeks prior to obtaining consent
(6) Patients who presented with hypoglycemic attacks within 4 weeks
(7) Patients with active infection within 4 weeks
(8) Patients with anatomical abnormalities causing urinary tract infections
(9) Patients currently taking SGLT2 inhibitors
(10) Patients currently taking tolvaptan
(11) Patients with a history of Type 1 diabetes or diabetic ketoacidosis (DKA)
(12) Patients judged to be at high risk for developing ketoacidosis due to excessive alcohol consumption, poor dietary intake, or strict low-carbohydrate diet
(13) Patients with surgery or severe trauma within 4 weeks prior to obtaining consent, or those scheduled for surgery during the study period
(14) Patients with a history of hypersensitivity to empagliflozin
(15) Patients who are pregnant or possibly pregnant
(16) Patients who are breastfeeding
(17) Other patients judged inappropriate for participation in this study by the Principal Investigator or Co-Investigator
18age old over
85age old not
Both
Liver cirrhosis with uncontrolled ascites complicated by Type 2 diabetes mellitus
Oral administration of empagliflozin 10 mg once daily for 4 weeks in patients with liver cirrhosis complicated by Type 2 diabetes who have not achieved sufficient ascites control with standard diuretic therapy.
Liver cirrhosis
empagliflozin
Change in body weight from baseline to Week 4 of administration
(1) Incidence rate of hospitalization events up to Week 4 of administration
(2) Frequency and volume of abdominal paracentesis drainage up to Week 4 of administration
(3) Frequency and amount of albumin administration up to Week 4 of administration
(4) Change in Ascites Grade from baseline to Week 4 of administration
(5) Improvement rate of lower leg edema
(6) Change in Child-Pugh score from baseline to Week 4 of administration
(7) Change in urinary sodium excretion rate from baseline to Week 4 of administration
(8) Change in serum sodium level from baseline to Week 4 of administration
(9) Change in serum creatinine level from baseline to Week 4 of administration
(10) Change in eGFR from baseline to Week 4 of administration
(11) Incidence rate of urinary tract infections up to Week 4 of administration
(12) Incidence rate of acute kidney injury (AKI) and its staging up to Week 4 of administration
(13) Correlation between the change in body weight and both the frequency of abdominal paracentesis drainage and the change in Ascites Grade
Ministry of Health, Labour and Welfare (Health and Labour Sciences Research Grants)
The University of Tokyo, Clinical Reserch Review Board
