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Sodium-glucose cotransporter 2 (SGLT2) inhibitor

Empagliflozin in Diuretic Refractory Ascites (DRAin-Em 01 Trial)

Phase 1
Waitlist Available
Led By Aparna Goel, MD
Research Sponsored by Stanford 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 baseline to 12 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing empagliflozin, a diabetes medication, to see if it can help patients with severe liver disease who have fluid buildup that doesn't respond to usual treatments. The medication helps reduce fluid and inflammation in the body and has shown benefits in reducing liver fat.

Eligible Conditions
  • Non-invasive Indices to Predict Hepatic Fibrosis in BA Patients.
  • Ascites
  • Liver Cirrhosis
  • Sodium-Glucose Cotransporter 2 Inhibitors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Participant retention rate as a measure of study feasibility
Secondary study objectives
Estimated glomerular filtration rate as a measure of kidney function
Mean change in abdominal girth from baseline to 12 weeks
Mean change in body weight from baseline to 12 weeks
+1 more

Side effects data

From 2019 Phase 2 trial • 80 Patients • NCT03200860
38%
Renal/Urinary
33%
Musculoskeletal
23%
Cardiovascular
23%
Metabolic
15%
Gastrointestinal
15%
Other
8%
Worsening Heart Failure
8%
Respiratory
3%
Worsening Renal Function
3%
S. Aureus Bacteremia
3%
Angioedema
3%
Acute Kidney Injury
3%
Syncope
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Empagliflozin

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Empagliflozin 10mg PO daily for 12 weeksExperimental Treatment1 Intervention
Single arm trial
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Empagliflozin 10 MG
2016
Completed Phase 4
~1110

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,491 Previous Clinical Trials
17,519,198 Total Patients Enrolled
Aparna Goel, MDPrincipal InvestigatorClinical Assistant Professor
2 Previous Clinical Trials
1,624 Total Patients Enrolled
~3 spots leftby Dec 2025
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