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NCT05614115 · ClinicalTrials.gov registry record · Phase 1

Safety, Tolerability, and Feasibility of Empagliflozin Therapy in Dialysis-dependent ESKD

A Phase 1 study of End-Stage Kidney Disease and Kidney Failure, sponsored by University of Utah.

Completed
Registry status
Phase 1
Development phase
62
Enrollment target
1
Study location

NCT05614115 is a Phase 1 study of End-Stage Kidney Disease and Kidney Failure that has completed, run by University of Utah. The registered enrollment target is 62 participants, below the 463-participant average among 20 other End-Stage Kidney Disease trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05614115, a Phase 1 study of End-Stage Kidney Disease and Kidney Failure, has completed, sponsored by University of Utah.

COMPLETED
Registry status
Phase 1
Development phase
62 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to find out if empagliflozin, a new diabetic medication that has been shown to be very effective in lowering the risk of heart failure, is safe and tolerated in dialysis patients. In the recent years, empagliflozin has become a major tool to prevent heart failure hospitalization and to reduce the risk for cardiovascular death in diabetic and non-diabetic patients. Although patients with severe chronic kidney disease and ESKD have very high risk of heart failure and cardiovascular death, they have been excluded from all of the previous studies. If this medication is found to be well tolerated and safe in dialysis patients through this study, future clinical studies can evaluate if this medication can also reduce the risk of heart failure and cardiovascular death in dialysis patients.

Interventions

  • OTHER Placebo
  • DRUG Empagliflozin

Study Locations (1)

Utah

  • University of Utah - Salt Lake City

Trial Details

FieldValue
Enrollment Target 62 participants
Start Date 2023-03-21
Est. Completion 2025-06-30
Phase Phase 1

Sponsor

University of Utah

818 total trials

What the Registry Record Tells You About NCT05614115

The ClinicalTrials.gov registry entry for NCT05614115 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 463-participant average among 20 other End-Stage Kidney Disease trials with a reported enrollment target (87% lower). The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.

The record links to 8 conditions, with End-Stage Kidney Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT05614115 reports 1 study location spanning 1 distinct geographic area - top geographies include Utah.

Frequently Asked Questions

What is clinical trial NCT05614115 about?

NCT05614115 is a clinical study titled "Safety, Tolerability, and Feasibility of Empagliflozin Therapy in Dialysis-dependent ESKD". The purpose of this study is to find out if empagliflozin, a new diabetic medication that has been shown to be very effective in lowering the risk of heart failure, is safe and tolerated in dialysis patients. In the recent years, empagliflozin has become a major tool to prevent heart failure hospita...

What is the current status of trial NCT05614115?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 62 participants. The study started on 2023-03-21. Estimated completion is 2025-06-30.

What conditions does trial NCT05614115 study?

This clinical trial studies the following conditions: End-Stage Kidney Disease, Kidney Failure, Hemodialysis, Kidney Disease, Chronic, Dialysis.

What interventions are being tested in trial NCT05614115?

The interventions under investigation include: Placebo (OTHER), Empagliflozin (DRUG).

Who is sponsoring clinical trial NCT05614115?

This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05614115 being conducted?

This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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