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NCT06531824 · ClinicalTrials.gov registry record · Phase 3

EASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin)

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

Recruiting
Registry status
Phase 3
Development phase
11,000
Enrollment target
20
Study locations

NCT06531824 is a Phase 3 study of Kidney Disease, Chronic that is actively recruiting participants, run by Boehringer Ingelheim. The registered enrollment target is 11,000 participants, above the 7,886-participant average among 7 other Kidney Disease, Chronic trials with a reported enrollment target (39% higher). The trial reports 20 study locations across 15 states.

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The verdict

NCT06531824, a Phase 3 study of Kidney Disease, Chronic, is actively recruiting participants, sponsored by Boehringer Ingelheim.

RECRUITING
Registry status
Phase 3
Development phase
11,000 participants
Enrollment target
20
Study locations

Study Summary

This study is open to adults with chronic kidney disease at risk of progression. People with and without type 2 diabetes can take part in this study. The study is open to people who take other medicines called angiotensin converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB). People who already take empagliflozin or any other sodium-glucose cotransporter-2 inhibitor (SGLT2i) can also join. The study is also open to people who currently do not take any of these treatments. The purpose of this study is to find out whether a medicine called BI 690517 helps people with chronic kidney disease when taken in combination with a study medicine called empagliflozin. Worsening of kidney function increases the risk for kidney failure, cardiovascular disease, and heart disease. This study has 2 parts. In the first part, participants get empagliflozin or placebo matching BI 690517 for at least 6 weeks. Participants continue taking ACEi or ARB throughout the study if such treatments are indicated. In the second part, participants are divided into 2 groups by chance. One group takes BI 690517 tablets and the other group takes placebo tablets. Placebo tablets look like BI 690517 tablets but do not contain any medicine. Participants take 1 tablet once a day in addition to empagliflozin for the duration of the study. The doctors document when participants experience worsening of their kidney disease, go to hospital due to heart failure, or die of cardiovascular problems during the study. The time to these events is compared between the 2 treatment groups to see whether the treatment works. The study continues until the required number of events have occurred which is about 3 to 4 years. During this time, participants visit the study site about 4 times within the first 6 months. Then they visit the study site every 6 months. At the visits, doctors regularly check participants' health, take blood and urine samples, measure blood pressure and weight, check kidney f

Conditions Studied

Kidney Disease, Chronic

Interventions

  • DRUG Empagliflozin
  • DRUG BI 690517
  • DRUG Placebo matching BI 690517

Study Locations (20)

Florida

  • Florida Kidney Physicians LLC - Jacksonville Beach
  • Total Research Group, LLC - Miami

Kansas

  • University of Kansas Medical Center - Kansas City
  • Kansas Nephrology Research Institute, LLC - Wichita

Michigan

  • Lake Michigan Nephrology - Saint Joseph
  • St. Clair Nephrology Research, LLC - Shelby

North Carolina

  • Metrolina Nephrology Associates, PA - Charlotte
  • Brookview Hills Research Associates LLC - Winston-Salem

Pennsylvania

  • Northeast Endocrine Metabolic Associates - Philadelphia
  • Clinical Renal Associates - Upland

Alabama

  • Apogee Clinical Research - Huntsville

Arizona

  • Southwest Kidney Institute - Surprise

Georgia

  • East Coast Institute For Research LLC - Macon

Trial Details

FieldValue
Enrollment Target 11,000 participants
Start Date 2024-08-13
Est. Completion 2028-08-30
Phase Phase 3

Sponsor

Boehringer Ingelheim

515 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06531824

The ClinicalTrials.gov registry entry for NCT06531824 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 11,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 7,886-participant average among 7 other Kidney Disease, Chronic trials with a reported enrollment target (39% higher). The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Kidney Disease, Chronic appearing as the primary indexed condition, and to 3 interventions - of which Empagliflozin is the first listed.

NCT06531824 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Florida, Kansas, Michigan.

Frequently Asked Questions

What is clinical trial NCT06531824 about?

NCT06531824 is a clinical study titled "EASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin)". This study is open to adults with chronic kidney disease at risk of progression. People with and without type 2 diabetes can take part in this study. The study is open to people who take other medicines called angiotensin converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB). Pe...

What is the current status of trial NCT06531824?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 11,000 participants. The study started on 2024-08-13. Estimated completion is 2028-08-30.

What conditions does trial NCT06531824 study?

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

What interventions are being tested in trial NCT06531824?

The interventions under investigation include: Empagliflozin (DRUG), BI 690517 (DRUG), Placebo matching BI 690517 (DRUG).

Who is sponsoring clinical trial NCT06531824?

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

Where is trial NCT06531824 being conducted?

This trial has 20 study locations across Alabama, Arizona, Florida, Georgia, Idaho. 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.