Empagliflozin in Diuretic Refractory Ascites

NCT05013502 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: IRB-61538
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Ascites is the most frequent complication of liver cirrhosis and results in increased morbidity and mortality but current medical management options are limited. Here, the investigators will conduct an interventional single-arm pilot clinical trial toevaluate the feasibility of empagliflozin in managing diuretic-resistant ascites in patients with decompensated cirrhosis. This single site, open label pilot study will enroll participants with decompensated cirrhosis at a single site. Participants will receive empagliflozin 10mg oral tablets once daily for 12 weeks with monitoring for safety and adverse events.

Conditions

Liver Cirrhosis; Cirrhosis; Ascites; Ascites Hepatic; Sodium-Glucose Transporter 2 Inhibitors

Keywords

diuretic refractory; diuretic resistant; empagliflozin

Outcome Measures

Primary Outcomes (1)

• Participant retention rate as a measure of study feasibility

  Retention rate and completion of trial activities through 12 weeks

  Baseline to 12 weeks

Secondary Outcomes (4)

• Mean change in abdominal girth from baseline to 12 weeks

  Baseline to 12 weeks

• Mean change in body weight from baseline to 12 weeks

  Baseline to 12 weeks

• Mean change in patient reported functional status

  Baseline to 12 weeks

• Estimated glomerular filtration rate as a measure of kidney function

  Baseline to 12 weeks

Study Arms (1)

Empagliflozin 10mg PO daily for 12 weeks

EXPERIMENTAL

Single arm trial

Drug: Empagliflozin 10 MG

Interventions

Empagliflozin 10 MG DRUG

empagliflozin 10mg PO once daily

Empagliflozin 10mg PO daily for 12 weeks

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Decompensated liver cirrhosis with ascites
• Diuretic-resistant ascites defined as one of the following: a) An inability to mobilize ascites despite adherence to dietary sodium restriction (2000 mg per day) and administration of maximum tolerable doses of oral diuretics; b) Rapid reaccumulation of fluid after therapeutic paracentesis despite adherence to a sodium-restricted diet. c) Development of diuretic-related complications such as progressive azotemia, hepatic encephalopathy, or progressive electrolyte imbalances
• Ability to understand and willingness to sign a written informed consent document

You may not qualify if:

• Hypersensitivity to any SGLT2 inhibitor
• Pregnant or breastfeeding women
• eGFR below 45mL/min/1.73m2 or decrease in eGFR by \>30% between screening
• Recurrent urinary tract infections or recurrent genitourinary fungal infections, defined as \> 2 infections in six months or \>3 infections in one year
• Hypotension requiring oral vasopressor therapy
• Patients with particular risk for ketoacidosis including active moderate or severe alcohol use disorder, pancreatitis, pancreatic insulin deficiency from any cause, or episode of ketoacidosis in the past
• History of skin or soft tissue infection requiring IV antibiotics including Fornier's gangrene or prior limb amputation
• Chronic alcohol or drug abuse or any condition that, in the investigator's opinion, makes them an unreliable trial subject or unlikely to complete the trial

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University Digestive Health Clinic

Redwood City, California, 94060, United States

Location

MeSH Terms

Conditions

Liver Cirrhosis; Fibrosis; Ascites

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Aparna Goel, MD

  Clinical Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Protocol Director

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: August 19, 2021
• Study Start: November 15, 2021
• Primary Completion: May 30, 2023
• Study Completion: June 30, 2023
• Last Updated: August 2, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)