Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2026-02-21 @ 2:54 PM
Study NCT ID:
NCT05726032
Status:
RECRUITING
Last Update Posted:
2025-10-07
First Post:
2023-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Empagliflozin in Patients With Cirrhosis and Ascites
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D017093', 'term': 'Liver Failure'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D048550', 'term': 'Hepatic Insufficiency'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C570240', 'term': 'empagliflozin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'double-blind placebo-controlled study'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Proof of concept, randomized, cross over, phase II double-blind placebo-controlled study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-06', 'studyFirstSubmitDate': '2023-02-02', 'studyFirstSubmitQcDate': '2023-02-02', 'lastUpdatePostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in FENa with administration of study drug (10 mg empagliflozin vs. identical placebo)', 'timeFrame': '14 days', 'description': 'Change in fractional excretion of sodium with administration of study drug (10 mg empagliflozin vs. identical placebo)'}, {'measure': 'Change in total body water (TBW) before and after a 14-day course of study drug', 'timeFrame': '14 days', 'description': 'Change in total body water (TBW) before and after a 14-day course of study drug (10 mg/day empagliflozin vs. identical placebo)'}], 'secondaryOutcomes': [{'measure': 'Change in renal blood flow before and after administration of study drug', 'timeFrame': 'Baseline to Hour 6', 'description': 'Change in renal blood flow (RBF) as determined by PAH clearance, before and after the acute administration of study drug ((RPF assessed using ancillary protocol on page 31)'}, {'measure': 'Change in plasma renin activity,total renin, aldosterone, norepinephrine and copeptin', 'timeFrame': '14 days', 'description': 'Change in plasma renin activity (PRA), total renin, aldosterone, norepinephrine and copeptin before and after a 14-day course of study drug'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cirrhosis', 'Liver Failure']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 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\n2. eGFR \\>= 30mL/min/1.73 m2\n3. \\>=18 years old\n\nExclusion Criteria:\n\n1. Hospitalization due to a complication of cirrhosis in the previous 8 weeks (e.g. variceal hemorrhage, encephalopathy, acute kidney injury, spontaneous bacterial peritonitis)\n2. Direct bilirubin \\>=3 mg/dL\n3. Systolic blood pressure \\< 100 mmHg\n4. Active malignancy including hepatocellular carcinoma undergoing treatment\n5. History of bladder dysfunction, incontinence, pyelonephritis, urosepsis, or frequent urinary tract infections\n6. Use of SGLT-2 inhibitors in the last 10 days, or previous use with intolerance\n7. Type 1 diabetes\n8. History of frequent hypoglycemic episodes\n9. 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 standard treatment for ascites along with SGLT2 inhibitor.\n10. Hepatic hydrothorax requiring thoracentesis in the prior 8 weeks\n11. Hepatic encephalopathy grade II or greater at the time of enrollment\n12. Patients who have had TIPS placed\n13. Previous liver transplant\n14. Participation in another trial with an investigational drug within the 30 days prior to informed consent\n15. Pregnancy or breastfeeding\n16. Inability to give written informed consent or follow study protocol (e.g. clinically-significant psychiatric, addictive, or neurological disease)\n17. Change in diuretic dose in the prior 2 weeks\n18. Patients with hospitalization for alcoholic hepatitis in the past 6 months\n19. Significant worsening of creatinine (more than 50% increase) in the past 4 weeks\n20. MELD-Na \\> or equal to 20\n21. Hemoglobin \\<8'}, 'identificationModule': {'nctId': 'NCT05726032', 'acronym': 'EMPA Liver', 'briefTitle': 'Empagliflozin in Patients With Cirrhosis and Ascites', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Effects of Empagliflozin on Natriuresis and Volume Overload in Patients With Cirrhosis and Ascites', 'orgStudyIdInfo': {'id': '2000034606'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Empagliflozin', 'description': 'Empagliflozin vs placebo for 14 days, followed by 14 day washout period, before crossing over to the alternate drug.', 'interventionNames': ['Drug: Empagliflozin 10 MG']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Empagliflozin vs placebo for 14 days, followed by 14 day washout period, before crossing over to the alternate drug.', 'interventionNames': ['Drug: Matching Placebo']}], 'interventions': [{'name': 'Empagliflozin 10 MG', 'type': 'DRUG', 'description': 'Participants will be randomized to Empagliflozin 10 mg or placebo for 14 days. A 14 day washout period follows and then participants is crossed over to the alternate treatment for 14 days.', 'armGroupLabels': ['Empagliflozin']}, {'name': 'Matching Placebo', 'type': 'DRUG', 'description': 'Participants will be randomized to Empagliflozin 10 mg or placebo for 14 days. A 14 day washout period follows and then participants is crossed over to the alternate treatment for 14 days.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Katherine Keith', 'role': 'CONTACT'}], 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'centralContacts': [{'name': 'Veena Rao, PHD', 'role': 'CONTACT', 'email': 'veena.s.rao@yale.edu', 'phone': '2037373571'}, {'name': 'Kara Otis', 'role': 'CONTACT', 'email': 'kara.otis@yale.edu', 'phone': '2037373571'}], 'overallOfficials': [{'name': 'Jeffrey Testani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}