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COMPLETED Phase 3

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

NCT03594110 · View on ClinicalTrials.gov ↗

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

203 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03594110

The ClinicalTrials.gov registry entry for NCT03594110 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 6,609 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 203 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03594110 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Florida, California, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03594110?

The interventions under investigation include: Matching placebo (DRUG), Empagliflozin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03594110?

This trial is sponsored by Boehringer Ingelheim, which has 203 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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