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Sodium-glucose cotransporter 2 (SGLT2) inhibitor
Empagliflozin for Cirrhosis with Ascites (EMPA Liver Trial)
Phase 2
Recruiting
Led By Jeffrey Testani, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days
Awards & highlights
Summary
This trial will investigate how a diabetes drug affects water balance and other bodily functions in people with cirrhosis.
Who is the study for?
This trial is for adults over 18 with cirrhosis and ascites who are on stable diuretic therapy, have an eGFR of at least 30 mL/min/1.73 m2, and haven't been hospitalized for cirrhosis complications in the last 8 weeks. People with direct bilirubin >=3 mg/dL, low blood pressure, active cancers, certain urinary issues, type 1 diabetes or those pregnant/breastfeeding cannot join.
What is being tested?
The study tests Empagliflozin's effects on salt excretion and body water in patients with liver scarring (cirrhosis) and fluid accumulation (ascites). It compares Empagliflozin to a placebo over two weeks to see if it changes hormone levels affecting the kidneys.
What are the potential side effects?
Empagliflozin may cause dehydration due to increased urination, low blood sugar levels especially in diabetic patients, urinary tract infections due to its action on glucose in urine which can promote bacterial growth.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in FENa with administration of study drug (10 mg empagliflozin vs. identical placebo)
Change in total body water (TBW) before and after a 14-day course of study drug
Secondary study objectives
Change in plasma renin activity,total renin, aldosterone, norepinephrine and copeptin
Change in renal blood flow before and after administration of study drug
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: EmpagliflozinActive Control1 Intervention
Empagliflozin vs placebo for 14 days, followed by 14 day washout period, before crossing over to the alternate drug.
Group II: PlaceboPlacebo Group1 Intervention
Empagliflozin vs placebo for 14 days, followed by 14 day washout period, before crossing over to the alternate drug.
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Who is running the clinical trial?
Boehringer IngelheimIndustry Sponsor
2,534 Previous Clinical Trials
11,357,507 Total Patients Enrolled
12 Trials studying Liver Failure
430 Patients Enrolled for Liver Failure
Yale UniversityLead Sponsor
1,907 Previous Clinical Trials
3,019,029 Total Patients Enrolled
Jeffrey Testani, MDPrincipal InvestigatorYale University
6 Previous Clinical Trials
619 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I was hospitalized for a liver-related complication within the last 8 weeks.I have had issues with bladder control or frequent urinary infections.I am currently being treated for an active cancer, including liver cancer.I am able to understand and follow the study's requirements.I am not using non-loop diuretics except for aldosterone antagonists for my cirrhosis.I have used SGLT-2 inhibitors recently or had a bad reaction to them before.I often experience low blood sugar episodes.I do not have severe confusion due to liver problems.I have had a liver transplant.I am 18 years old or older.My diuretic dose hasn't changed in the last 4 weeks.I have cirrhosis with ascites, manage it with stable diuretics, and don't need frequent fluid removal.I have fluid in my chest due to liver problems.
Research Study Groups:
This trial has the following groups:- Group 1: Empagliflozin
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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