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New treatment option for Cirrhosis
Official title Empagliflozin in Patients With Cirrhosis and Ascites
ClinicalTrials.gov ID: NCT05726032
What this study is testing
What is Empagliflozin 10 MG?
Empagliflozin 10 MG is an investigational medicine, being studied as a potential treatment for cirrhosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A proof-of-concept placebo-controlled trial to explore the acute and 14-day effects of empagliflozin on natriuresis and total body water in patients with cirrhosis and ascites. We will additionally investigate its effect on neurohumoral activation, and renal hemodynamics.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients with cirrhosis and ascites on a stable dose of diuretics (spironolactone +/- loop-diuretics based on AASLD guidelines)10 and who do not...
- eGFR \>= 30mL/min/1.73 m2
- \>=18 years old
You likely can't join if
- Hospitalization due to a complication of cirrhosis in the previous 8 weeks (e.g. variceal hemorrhage, encephalopathy, acute kidney injury...
- Direct bilirubin \>=3 mg/dL
- Systolic blood pressure \< 100 mmHg
- Active malignancy including hepatocellular carcinoma undergoing treatment
- History of bladder dysfunction, incontinence, pyelonephritis, urosepsis, or frequent urinary tract infections
- Use of SGLT-2 inhibitors in the last 10 days, or previous use with intolerance
See the full eligibility criteria
- Patients with cirrhosis and ascites on a stable dose of diuretics (spironolactone +/- loop-diuretics based on AASLD guidelines)10 and who do not require large volume paracenteses
- eGFR \>= 30mL/min/1.73 m2
- \>=18 years old
- Hospitalization due to a complication of cirrhosis in the previous 8 weeks (e.g. variceal hemorrhage, encephalopathy, acute kidney injury, spontaneous bacterial peritonitis)
- Direct bilirubin \>=3 mg/dL
- Systolic blood pressure \< 100 mmHg
- Active malignancy including hepatocellular carcinoma undergoing treatment
- History of bladder dysfunction, incontinence, pyelonephritis, urosepsis, or frequent urinary tract infections
- Use of SGLT-2 inhibitors in the last 10 days, or previous use with intolerance
- Type 1 diabetes
- History of frequent hypoglycemic episodes
- Use of a non-loop diuretic aside from aldosterone antagonists or amiloride as they are not standard of care in patients with cirrhosis and could potentially increase the risk of hypovolemia when combined with the...
- Hepatic hydrothorax requiring thoracentesis in the prior 8 weeks
- Hepatic encephalopathy grade II or greater at the time of enrollment
- Patients who have had TIPS placed
- Previous liver transplant
- Participation in another trial with an investigational drug within the 30 days prior to informed consent
- Pregnancy or breastfeeding
- Inability to give written informed consent or follow study protocol (e.g. clinically-significant psychiatric, addictive, or neurological disease)
- Change in diuretic dose in the prior 2 weeks
- Patients with hospitalization for alcoholic hepatitis in the past 6 months
- Significant worsening of creatinine (more than 50% increase) in the past 4 weeks
- MELD-Na \> or equal to 20
- Hemoglobin \<8
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.