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NCT05687058 · ClinicalTrials.gov registry record · Phase 1

Empagliflozin in ESKD - A Feasibility Study

A Phase 1 study of Heart Failure and Kidney Failure, Chronic, sponsored by University of Mississippi Medical Center.

Recruiting
Registry status
Phase 1
Development phase
24
Enrollment target
2
Study locations

NCT05687058 is a Phase 1 study of Heart Failure and Kidney Failure, Chronic that is actively recruiting participants, run by University of Mississippi Medical Center. The registered enrollment target is 24 participants, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 1 state.

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The verdict

NCT05687058, a Phase 1 study of Heart Failure and Kidney Failure, Chronic, is actively recruiting participants, sponsored by University of Mississippi Medical Center.

RECRUITING
Registry status
Phase 1
Development phase
24 participants
Enrollment target
2
Study locations

Study Summary

The aim of this study is to learn about the safety of empagliflozin in dialysis patients as a preparation for a future large clinical trial. Empagliflozin has been approved by the Food and Drug Administration for the treatment of either type 2 diabetes, heart failure, or chronic kidney disease among patients not on dialysis. The use of empagliflozin has not been studied or approved among patients on dialysis for kidney failure because empagliflozin acts on the kidneys. However, recent experimental studies have indicated that empagliflozin may provide direct heart benefits. Some dialysis patients have substantial residual kidney function, which may be protected by empagliflozin. Participants will be given empagliflozin for three (3) months on top of the standard of care (usual medical care for participants' condition) and will be followed up until one (1) month after the last dose. The investigators will collect information about participants' general health, obtain blood, urine, and imaging studies, check home blood pressure, monitor home blood sugar levels, and ask health-related questions to assess the safety and potential benefits of empagliflozin over four (4) months, including one month before the three (3)-month empagliflozin treatment.

Conditions Studied

Heart Failure Kidney Failure, Chronic

Interventions

  • DRUG Empagliflozin 25 mg thrice-weekly post-hemodialysis dosing
  • DRUG Empagliflozin 10 mg daily dosing

Study Locations (2)

Mississippi

  • University of Mississippi Medical Center - Jackson
  • Jackson Medicall Mall Dialysis Clinic - Jackson

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2023-11-01
Est. Completion 2025-12-31
Phase Phase 1

Sponsor

University of Mississippi Medical Center

96 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05687058

The ClinicalTrials.gov registry entry for NCT05687058 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (99% lower). The listed sponsor is University of Mississippi Medical Center, which has 96 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Heart Failure appearing as the primary indexed condition, and to 2 interventions - of which Empagliflozin 25 mg thrice-weekly post-hemodialysis dosing is the first listed.

NCT05687058 reports 2 study locations spanning 1 distinct geographic area - top geographies include Mississippi.

Frequently Asked Questions

What is clinical trial NCT05687058 about?

NCT05687058 is a clinical study titled "Empagliflozin in ESKD - A Feasibility Study". The aim of this study is to learn about the safety of empagliflozin in dialysis patients as a preparation for a future large clinical trial. Empagliflozin has been approved by the Food and Drug Administration for the treatment of either type 2 diabetes, heart failure, or chronic kidney disease among...

What is the current status of trial NCT05687058?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2023-11-01. Estimated completion is 2025-12-31.

What conditions does trial NCT05687058 study?

This clinical trial studies the following conditions: Heart Failure, Kidney Failure, Chronic.

What interventions are being tested in trial NCT05687058?

The interventions under investigation include: Empagliflozin 25 mg thrice-weekly post-hemodialysis dosing (DRUG), Empagliflozin 10 mg daily dosing (DRUG).

Who is sponsoring clinical trial NCT05687058?

This trial is sponsored by University of Mississippi Medical Center, which has 96 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05687058 being conducted?

This trial has 2 study locations across Mississippi. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.