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NCT03594110 · ClinicalTrials.gov registry record · Phase 3

EMPA-KIDNEY (The Study of Heart and Kidney Protection With Empagliflozin)

A Phase 3 study of Chronic Kidney Disease, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 3
Development phase
6,609
Enrollment target
20
Study locations

NCT03594110 is a Phase 3 study of Chronic Kidney Disease that has completed, run by Boehringer Ingelheim. The registered enrollment target is 6,609 participants, above the 3,141-participant average among 101 other Chronic Kidney Disease trials with a reported enrollment target (110% higher). The trial reports 20 study locations across 9 states.

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The verdict

NCT03594110, a Phase 3 study of Chronic Kidney Disease, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 3
Development phase
6,609 participants
Enrollment target
20
Study locations

Study Summary

The primary aim of the study is to investigate the effect of empagliflozin on kidney disease progression or cardiovascular death versus placebo on top of standard of care in patients with pre-existing chronic kidney disease. After completion of the interventional part of the study (primary study completion) a subset of participants will be followed up in a post-trial observational (non-interventional) manner for cardio-renal outcomes (estimated study completion date).

Conditions Studied

Interventions

  • DRUG Matching placebo
  • DRUG Empagliflozin

Study Locations (20)

Florida

  • Midland Florida Clinical Reearch Center, LLC - DeLand
  • University of Florida - Gainesville
  • East Coast Institute for Research, LLC - Jacksonville
  • East Coast Clinical Research, Inc - Lake City
  • Total Research Group, LLC - Miami
  • Hanson Clinical Research Center, Inc. - Port Charlotte

California

  • Southern California Permanente Medical Group - San Diego
  • University of California Los Angeles - Sylmar
  • University of California Los Angeles - Torrance

Connecticut

  • Yale University School of Medicine - New Haven
  • Chase Medical Research, LLC - Thomaston

Georgia

  • Emory University - Atlanta
  • The Jones Center for Diabetes and Endocrine Wellness - Macon

Illinois

  • Cedar Crosse Research Center - Chicago
  • Northwestern University - Chicago

Kentucky

  • Saint Elizabeth Healthcare - Covington
  • Lexington VA Health Care System - Troy Bowling Campus - Lexington

Alabama

  • Nephrology Consultants, LLC - Huntsville

Arizona

  • Aventiv Research, Inc - Mesa

Trial Details

FieldValue
Enrollment Target 6,609 participants
Start Date 2019-01-31
Est. Completion 2024-07-02
Phase Phase 3

Sponsor

Boehringer Ingelheim

515 total trials

What the Registry Record Tells You About NCT03594110

The ClinicalTrials.gov registry entry for NCT03594110 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 6,609 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 3,141-participant average among 101 other Chronic Kidney Disease trials with a reported enrollment target (110% higher). The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Chronic Kidney Disease appearing as the primary indexed condition, and to 2 interventions - of which Matching placebo is the first listed.

NCT03594110 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Florida, California, Connecticut.

Frequently Asked Questions

What is clinical trial NCT03594110 about?

NCT03594110 is a clinical study titled "EMPA-KIDNEY (The Study of Heart and Kidney Protection With Empagliflozin)". The primary aim of the study is to investigate the effect of empagliflozin on kidney disease progression or cardiovascular death versus placebo on top of standard of care in patients with pre-existing chronic kidney disease. After completion of the interventional part of the study (primary study com...

What is the current status of trial NCT03594110?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 6,609 participants. The study started on 2019-01-31. Estimated completion is 2024-07-02.

What conditions does trial NCT03594110 study?

This clinical trial studies the following conditions: Chronic Kidney Disease.

What interventions are being tested in trial NCT03594110?

The interventions under investigation include: Matching placebo (DRUG), Empagliflozin (DRUG).

Who is sponsoring clinical trial NCT03594110?

This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03594110 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Florida. 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

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.