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Sodium-glucose cotransporter 2 (SGLT2) inhibitor

Empagliflozin for Kidney Failure

Phase 1 & 2
Recruiting
Led By Yoshitsugu Obi, MD, PhD
Research Sponsored by University of Mississippi Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of end-stage kidney disease requiring dialysis
diagnosis of end-stage kidney disease requiring dialysis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Study Summary

This trial will test the safety of empagliflozin in dialysis patients; results may lead to a larger clinical trial to explore the potential heart benefits of empagliflozin.

Who is the study for?
This trial is for adults over 18 with end-stage kidney disease on dialysis. They must be able to consent and not have had recent major surgery, active cancer, heart or liver transplants, severe low blood pressure before dialysis, certain infections or urinary issues in the past year, advanced heart failure needing devices or drugs to help the heart work, liver cirrhosis, a history of ketoacidosis within a year, known allergies to SGLT2 inhibitors like empagliflozin.Check my eligibility
What is being tested?
The study tests if empagliflozin is safe for patients on dialysis due to kidney failure. It explores two dosing methods: one takes 25 mg after each hemodialysis session (thrice-weekly), and another takes 10 mg daily. Participants will also receive standard medical care during the three-month treatment period plus follow-up for an additional month.See study design
What are the potential side effects?
Potential side effects of empagliflozin may include urinary tract infections due to increased sugar in urine which bacteria feed on; dehydration because it causes more urination; low blood pressure; and ketoacidosis—a serious condition where too much acid builds up in the blood.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am on dialysis for end-stage kidney disease.
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I am on dialysis for end-stage kidney disease.
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I am 18 years old or older.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Blood empagliflozin concentrations after the first dose among patients on peritoneal dialysis
Completion rate of timed urine collection
Dropout rate
+7 more
Secondary outcome measures
% Time of active CGM
All-cause mortality
Average glucose
+37 more
Other outcome measures
Semi-structured interview

Trial Design

2Treatment groups
Experimental Treatment
Group I: Empagliflozin 25 mg thrice-weekly post-hemodialysis dosingExperimental Treatment1 Intervention
All participants undergoing thrice-weekly hemodialysis (HD) on the Monday-Wednesday-Friday (MWF) schedule will be assigned to the empagliflozin 25 mg thrice-weekly post-hemodialysis dosing arm (Group I).
Group II: Empagliflozin 10 mg daily dosingExperimental Treatment1 Intervention
Patients undergoing thrice-weekly hemodialysis (HD) on the Tuesday-Thursday-Saturday (TTS) schedule, patients on twice-weekly HD, or patients on peritoneal dialysis will receive empagliflozin 10 mg daily (Group II).

Find a Location

Who is running the clinical trial?

University of Mississippi Medical CenterLead Sponsor
174 Previous Clinical Trials
195,363 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,620 Previous Clinical Trials
3,216,575 Total Patients Enrolled
Yoshitsugu Obi, MD, PhDPrincipal InvestigatorUniversity of Mississippi Medical Center

Media Library

Empagliflozin (Sodium-glucose cotransporter 2 (SGLT2) inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05687058 — Phase 1 & 2
Chronic Kidney Failure Research Study Groups: Empagliflozin 10 mg daily dosing, Empagliflozin 25 mg thrice-weekly post-hemodialysis dosing
Chronic Kidney Failure Clinical Trial 2023: Empagliflozin Highlights & Side Effects. Trial Name: NCT05687058 — Phase 1 & 2
Empagliflozin (Sodium-glucose cotransporter 2 (SGLT2) inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05687058 — Phase 1 & 2
Chronic Kidney Failure Patient Testimony for trial: Trial Name: NCT05687058 — Phase 1 & 2

Frequently Asked Questions

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

Are there any vacant positions available in this research endeavor?

"The clinical trial hosted on clinicialtrials.gov is not currently enrolling patients, having first been posted in January 1st 2023 and last updated on December 12th 2023. However, there are 953 other trials actively seeking volunteers at this moment."

Answered by AI

Who else is applying?

What state do they live in?
Alabama
What site did they apply to?
University of Mississippi Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I've tried different medications and lifestyle changes and still ending up in the hospital.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Empagliflozin in ESKD - A Feasibility Study
2023. "Empagliflozin in ESKD - A Feasibility Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05687058.
All > Heart Failure With Preserved Ejection Fraction
~11 spots leftby Aug 2024
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