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

StatusActive, Not Recruiting

PhasePhase 3

SponsorBoehringer Ingelheim

Started2024-08-30

View on ClinicalTrials.gov ↗

Amendment history

2026-09-18

Trial sites expanded: 520 → 557 locations

2026-09-01

Study Status, Contacts/Locations v44

Enrollment closed, study ongoing

Primary completion moved earlier: 2028-08-30 → 2026-12-31

Completion moved earlier: 2028-08-30 → 2026-12-31

Trial sites expanded: 515 → 520 locations

2026-08-20

Study Status, Contacts/Locations v43

Trial sites expanded: 497 → 515 locations

2026-08-06

Study Status, Study Description, Outcome Measures, Eligibility, Contacts/Locations v42

Trial sites expanded: 480 → 497 locations

Eligibility criteria+228 characters

[...] demiology Collaboration (CKD-EPI) eGFR ≥20 <45 mL/min/1.73m² (irrespective of diabetes status); or No self-reported diabetes: CKD-EPI eGFR ≥45 <90 mL/min/1.73m² with urine albumin-to-creatinine ratio (uACR) ≥~~200~~150 mg/g (or protein-to-creatinine ratio ≥~~300~~225 mg/g); or Self-reported diabetes: CKD-EPI eGFR ≥45 <90 mL/min/1.73m² with uACR ≥30 mg/g (or protein-to-creatinine ratio ≥45 mg/g). Neither requires an Aldosterone Synthase inhibitor ( [...] ase (AST) >3x Upper Limit of Normal (ULN) at Screening visit (only one is required, with ALT preferred) Known liver cirrhosis On dialysis, functioning kidney [...]

Secondary endpoints7 to 6 entries

Key secondary outcome: ~~Annual rate of change in eGFR from 3 month visit until last scheduled visit (i.e. chronic eGFR slope)~~ Time to first event of kidney failure, hospitalization for heart failure or cardiovascular death Key secondary outcome: Time to ~~kidney~~first ~~disease progression Occurrences~~event of ~~hospitalizations~~hospitalization for heart failure ~~(first and any subsequent, combined)~~ or cardiovascular death Key secondary outcome: Occurrences of hospitalizations from any cause (first and any subsequent, combined) or death from any cause Key secondary outcome: Time to death from any cause K [...]

2026-06-23

Study Status, Arms and Interventions, Contacts/Locations v41

Trial sites expanded: 475 → 480 locations

2026-06-09

Study Status, Study Description, Contacts/Locations v40

Trial sites expanded: 459 → 475 locations

2026-05-31

Study Status, Contacts/Locations v39

Trial sites expanded: 452 → 459 locations

Start date2024-08-13→2024-08-30

2026-04-28

Study Status, Contacts/Locations v38

Trial sites expanded: 429 → 452 locations

2026-04-14

Study Status, Contacts/Locations v37

Trial sites expanded: 413 → 429 locations

2026-04-01

Study Status, Contacts/Locations v36

Trial sites expanded: 399 → 413 locations

2026-03-17

Study Status, Contacts/Locations v35

Study sites400→399

2026-03-04

Study Status, Contacts/Locations v34

Study sites377→400

2026-02-17

Study Status, Contacts/Locations v33

Study sites348→377

2026-02-04

Study Status, Contacts/Locations, IPDSharing, References v32

Study sites348 entries, revised

CHUC - Centro ~~Hospitais~~Hospitalar dae ~~Universidade~~Universitário de Coimbra, EPE

2026-01-20

Study Status, Contacts/Locations v31

Study sites329→348

2025-12-19

Study Status, Contacts/Locations v30

Study sitesdetails revised at 4 of 329 sites

2025-12-11

Study Status, Contacts/Locations v29

Study sites258→329

2025-11-11

Study Status, Contacts/Locations v28

Study sites258 entries, revised

Azienda ~~Ospedaliera~~Ospedaliero Universitaria Careggi

2025-10-29

Study Status, Contacts/Locations v27

Study sites222→258

2025-10-15

Study Status, Contacts/Locations v26

Study sites200→222

2025-09-17

Study Status, Contacts/Locations v25

Study sites189→200

2025-08-21

Study Status, Contacts/Locations v24

Study sites162→189

2025-07-30

Study Status, Contacts/Locations v23

Study sites152→162

2025-07-08

Study Status, Contacts/Locations v22

Study sites146→152

2025-06-25

Study Status, Contacts/Locations v21

Study sites116→146

2025-06-10

Study Status, Contacts/Locations v20

Study sites111→116

2025-05-27

Study Status, Contacts/Locations v19

Study sites104→111

2025-05-13

Study Status, Contacts/Locations v18

Study sitesdetails revised at 10 of 104 sites

2025-04-30

Study Status, Contacts/Locations v17

Study sites71→104

2025-04-22

Study Status, Contacts/Locations v16

Study sites63→71

2025-03-31

Study Status, Contacts/Locations v15

Study sites53→63

2025-03-25

Study Status, Contacts/Locations v14

Study sites45→53

2025-03-03

Study Status, Contacts/Locations v13

Study sites51→45

2025-02-24

Study Status, Contacts/Locations v12

Primary completion date2029-01-31→2028-08-30

Completion date2029-01-31→2028-08-30

Study sites48→51

2025-02-07

Study Status, Contacts/Locations v11

Primary completion date2028-08-30→2029-01-31

Completion date2028-08-30→2029-01-31

Study sites20→48

2025-01-21

Study Status, Contacts/Locations v10

Study sites5→20

2024-12-20

Study Status, Contacts/Locations v9

Study sites3→5

2024-12-10

Study Status, Contacts/Locations v8

Start date2024-08-30→2024-08-13

Study sitescontacts updated at 1 of 3 sites

2024-11-28

Study Status, Contacts/Locations v7

Study sites2→3

2024-11-16

Study Status v6

Start date2024-10-15→2024-08-30

2024-10-30

Study Status, Contacts/Locations v5

Start date2024-08-30→2024-10-15

Study sites1→2

2024-09-25

Study Status, Arms and Interventions v4

Re-verified, no change to tracked fields

2024-09-06

Not Yet Recruiting→Recruiting Study Status, Arms and Interventions, Contacts/Locations v3

Trial statusNot Yet Recruiting→Recruiting

Study sites0→1

2024-08-19

Study Status v2

Start date2024-08-14→2024-08-30

2024-08-06

Study Status, Study Description v1

Start date2024-08-07→2024-08-14

2024-07-29

Original filing

Boehringer Ingelheim

221 trials monitored

See 15 trials at risk

Chronic Kidney Disease

1,314 trials monitored

See 54 trials at risk

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 failure hospitalisation. After a run-in period, during which participants are confirmed to be receiving clinically appropriate renin-angiotensin system blockade and are established on empagliflozin, they are randomly assigned (by chance) to 1 of 2 groups. One group receives BI 690517 tablets, and the other group receives placebo tablets. Placebo tablets look like BI 690517 but do not contain any medicine. Participants take 1 study 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 5 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 function, and take note of any unwanted effects.

Trial Details

NCT Number	NCT06531824
Lead Sponsor	Boehringer Ingelheim
Conditions	Kidney Disease, Chronic
Enrollment	11,000 participants
Start Date	2024-08-30
Primary Completion	2026-12-31 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-10-01