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Sodium-glucose cotransporter 2 (SGLT2) inhibitor

Empagliflozin 10 MG for Liver Cirrhosis (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

DRAin-Em 01 Trial Summary

This trial will evaluate the feasibility of using empagliflozin to manage ascites in patients with decompensated cirrhosis. The trial will be single site and open label, enrolling participants who will receive empagliflozin 10mg once daily for 12 weeks.

Eligible Conditions
  • Liver Cirrhosis
  • Ascites
  • Sodium-Glucose Cotransporter 2 Inhibitors

DRAin-Em 01 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Participant retention rate as a measure of study feasibility
Secondary outcome measures
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%
Other
15%
Gastrointestinal
8%
Worsening Heart Failure
8%
Respiratory
3%
Angioedema
3%
Acute Kidney Injury
3%
S. Aureus Bacteremia
3%
Worsening Renal Function
3%
Syncope
100%
80%
60%
40%
20%
0%
Study treatment Arm
Empagliflozin
Placebo

DRAin-Em 01 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
~900

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,387 Previous Clinical Trials
17,334,036 Total Patients Enrolled
5 Trials studying Liver Cirrhosis
1,483 Patients Enrolled for Liver Cirrhosis
Aparna Goel, MDPrincipal InvestigatorClinical Assistant Professor
2 Previous Clinical Trials
1,624 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have been recruited for this investigation?

"Affirmative. Clinicaltrials.gov has information that this research trial is recruiting participants, which began on November 15th 2021 and was most recently revised on October 19th 2022. The investigation requires 12 people at a single site to participate."

Answered by AI

What medical ailments is Empagliflozin 10 MG traditionally prescribed to address?

"Empagliflozin 10 MG is widely prescribed for cardiovascular diseases, and has been known to reduce the risk of mortality from heart failure or diabetes mellitus type 2."

Answered by AI

Are there still opportunities for individuals to join this trial?

"Yes, the clinical trial is currently open for enrollment. As of October 19th 2022, it had been listed on clinicaltrials.gov since November 15 2021 and 12 people are needed from one site to participate in this research project."

Answered by AI

Is it possible for me to participate in this experiment?

"Aspiring applicants must meet two criteria: they must be between 18 and 75 years old, with a confirmed case of ascites. The total number of participants accepted into the trial is estimated to reach 12 individuals."

Answered by AI

Has the FDA authorized use of Empagliflozin 10 MG?

"As this is a Phase 1 clinical trial, there are limited data to confirm the safety and efficacy of Empagliflozin 10 MG. Thus our team at Power provided it with a score of 1."

Answered by AI

Is this study a pioneering endeavor in its area of research?

"Since its initial trial in 2018, sponsored by Boehringer Ingelheim and involving 175 participants, Empagliflozin 10 MG has undergone rigorous testing. After achieving Phase 3 approval of the drug candidate, there are currently 49 active studies occurring across 237 cities and 43 nations."

Answered by AI

Have any past investigations utilized Empagliflozin 10 MG?

"At the present, there are 49 ongoing trials assessing Empagfilozin 10 MG with 13 in their final phase. These investigations span a wide geographic area and although many studies are situated around Quilmes, Maryland; 1012 other sites worldwide have research related to this drug."

Answered by AI

Does this trial have an age limit, and if yes, what is the uppermost boundary?

"The prerequisites for participating in this trial entails being between 18 to 75 years of age. Currently, there are 80 trials recruiting minors and 486 studies searching for elderly participants."

Answered by AI

Who else is applying?

What state do they live in?
Iowa
How old are they?
18 - 65
What site did they apply to?
Stanford University Digestive Health Clinic
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Empagliflozin in Diuretic Refractory Ascites
Aparna Goel 2021. "Empagliflozin in Diuretic Refractory Ascites". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05013502.
~4 spots leftby Apr 2025
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