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EASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin)
NCT06531824 · View on ClinicalTrials.gov ↗
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
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
| Field | Value |
|---|---|
| Enrollment Target | 11,000 participants |
| Start Date | 2024-08-13 |
| Est. Completion | 2028-08-30 |
| Phase | Phase 3 |
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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. 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 11,000 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 Kidney Disease, Chronic appearing as the primary indexed condition, and to 3 interventions — of which Empagliflozin 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: NCT06531824 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Florida, Kansas, Michigan. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06531824?
The interventions under investigation include: Empagliflozin (DRUG), BI 690517 (DRUG), Placebo matching BI 690517 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06531824?
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 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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