Phase 2: testing Empagliflozin 10 MG for Cirrhosis
A proof-of-concept compared with a dummy treatment 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.
Official registry: https://clinicaltrials.gov/study/NCT05726032 · Yale University · enrollment listed as 20
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Empagliflozin 10 MG, or Matching Placebo. The registry lists allocation as randomized. A proof-of-concept compared with a dummy treatment trial to explore the acute and 14-day effects of empagliflozin on natriuresis and total body water in patients with cirrhosis and ascites.
They plan to enroll about 20 people at New Haven. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
Effects of Empagliflozin on Natriuresis and Volume Overload in Patients With Cirrhosis and Ascites
Interventions: Empagliflozin 10 MG, Matching Placebo
Primary outcome (registry wording): Change in FENa with administration of study drug (10 mg empagliflozin vs. identical placebo)
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- 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
Who the registry excludes
- 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
- History of frequent hypoglycemic episodes
Public study contact (from the registry)
Veena Rao, PHD
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- Yale University — New Haven, Connecticut (recruiting)
FAQ about this NCT record
Is NCT05726032 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT05726032?
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT05726032?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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