Clinical Research Directory
Browse clinical research sites, groups, and studies.
EASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin)
Sponsor: Boehringer Ingelheim
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 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.
Official title: A Multicenter, International, Randomized, Double-blind, Placebo-controlled Clinical Trial of the Aldosterone Synthase Inhibitor BI 690517 in Combination With Empagliflozin in Patients With Chronic Kidney Disease
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
8371
Start Date
2024-08-30
Completion Date
2026-12-31
Last Updated
2026-10-28
Healthy Volunteers
No
Conditions
Interventions
BI 690517
BI 690517 (called Type M randomized treatment)
Placebo matching BI 690517
Placebo matching BI 690517
Empagliflozin
Empagliflozin (called Type E)
Locations (562)
Apogee Clinical Research
Huntsville, Alabama, United States
Southwest Kidney Institute
Surprise, Arizona, United States
National Heart Institute
Beverly Hills, California, United States
Olive View - UCLA Medical Cente
Sylmar, California, United States
Interventional Cardiology Medical Group
West Hills, California, United States
South Denver Cardiology Associates
Littleton, Colorado, United States
Flourish Research
Boca Raton, Florida, United States
University of Florida Health Shands Hospital
Gainesville, Florida, United States
Florida Kidney Physicians LLC
Jacksonville Beach, Florida, United States
Total Research Group, LLC
Miami, Florida, United States
Bioresearch Partner
Miami, Florida, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Joseph Maxwell Cleland Atlanta VA Medical Center
Decatur, Georgia, United States
East Coast Institute For Research LLC
Macon, Georgia, United States
Kootenai Research Services
Coeur d'Alene, Idaho, United States
Northwestern University
Chicago, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Kansas Nephrology Research Institute, LLC
Wichita, Kansas, United States
University of Louisville
Louisville, Kentucky, United States
Medstar Health Research Institute
Baltimore, Maryland, United States
Lake Michigan Nephrology
Saint Joseph, Michigan, United States
St. Clair Nephrology Research, LLC
Shelby, Michigan, United States
Minneapolis VA Health Care System
Minneapolis, Minnesota, United States
Southwest Mississippi Nephrology, Pllc
Brookhaven, Mississippi, United States
Great Plains Nephrology
North Platte, Nebraska, United States
VA Southern Nevada Healthcare System
North Las Vegas, Nevada, United States
Sierra Nevada Specialty Care
Reno, Nevada, United States
Seacoast Kidney and Hypertension Specialists
Portsmouth, New Hampshire, United States
Advanced Heart Care, LLC
Bridgewater, New Jersey, United States
UNM Health Science Center
Albuquerque, New Mexico, United States
VA New York Harbor Healthcare System
New York, New York, United States
Metrolina Nephrology Associates, PA
Charlotte, North Carolina, United States
Metrolina Nephrology Associates, PA
Charlotte, North Carolina, United States
Carolina Kidney Associates
Greensboro, North Carolina, United States
Brookview Hills Research Associates LLC
Winston-Salem, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Northeast Endocrine Metabolic Associates
Philadelphia, Pennsylvania, United States
Temple University
Philadelphia, Pennsylvania, United States
Clinical Renal Associates
Upland, Pennsylvania, United States
Nephrology Associates, Inc
East Providence, Rhode Island, United States
University of Tennessee
Memphis, Tennessee, United States
Research Management, Inc - Austin
Austin, Texas, United States
Dallas Nephrology Associates Medical Clinic
DeSoto, Texas, United States
Academy Of Diabetes, Thyroid And Endocrine, PA
El Paso, Texas, United States
P&I Clinical Research, LLC
Lufkin, Texas, United States
Texas Institute for Kidney and Endocrine Disorders
Lufkin, Texas, United States
Renal Specialists of Houston, PA
Pasadena, Texas, United States
University Health
San Antonio, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Kidney and Hypertension Specialists, PLLC
Manassas, Virginia, United States
Tidewater Physicians Multispecialty Group
Newport News, Virginia, United States
Salem VA Medical Center
Salem, Virginia, United States
Providence Medical Research Center
Spokane, Washington, United States
Fundacion INTECNUS
Bariloche, Argentina
Terapia Renal Domiciliaria
Buenos Aires, Argentina
Centro de Salud Renal Junin SRL
Buenos Aires, Argentina
Dres. Iribarren & Asoc. Consultario
Buenos Aires, Argentina
Glenny Corp - Centro Medico Saavedra
Buenos Aires, Argentina
CPSIC SRL - Cardiologia Palermo
CABA, Argentina
Sanatorio Pasteur S.A
Catamarca, Argentina
CEMIC
Ciudad Autonoma Buenos Aires, Argentina
CIMEL Chahin - Chahin S.A.
Lanús Este, Argentina
Centro Nefrologico del Mar
Mar del Plata, Argentina
Mains Bleues
Rafaela, Argentina
Hospital Privado de Rosario
Rosario, Argentina
Sanatorio Parque S.A.
Rosario, Argentina
Instituto de Nefrourologia y Nutricion de Salta
Salta, Argentina
Clinica El Castaño
San Juan, Argentina
Centro de Investigaciones Medicas Tucuman
San Miguel de Tucumán, Argentina
Centro Integral de Medicina Respiratoria - CIMER
San Miguel de Tucumán, Argentina
Instituto de Investigaciones Clinicas de Rosario
Santa Fe, Argentina
CEREHA S.A.- Centro de Estudios Renales e Hipertension Arterial
Villa Domínico, Argentina
Concord Hospital
Concord, New South Wales, Australia
Renal Research, Gosford
Gosford, New South Wales, Australia
Nepean Hospital
Kingswood, New South Wales, Australia
St George Hospital
Kogarah, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
Port Macquarie Base Hospital (PMBH)
Port Macquarie, New South Wales, Australia
Hervey Bay Hospital
Pialba, Queensland, Australia
AOVO Clinical Trials
Southport, Queensland, Australia
Griffith University
Southport, Queensland, Australia
Toowoomba Hospital
Toowoomba, Queensland, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Eastern Health-Box Hill Hospital
Box Hill, Victoria, Australia
Austin Health
Heidelberg Heights, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
St Vincent's Hospital Melbourne
Melbourne, Victoria, Australia
Sunshine Hospital
St Albans, Victoria, Australia
Macquarie University
New South Wales, Australia
Westmead Hospital
New South Wales, Australia
AZ Sint-Jan Brugge
Bruges, Belgium
Ziekenhuis Oost-Limburg
Genk, Belgium
UZ Brussel
Jette, Belgium
Centre Hospitalier Universitaire de Liège
Liège, Belgium
Centro de Pesquisa Clínica do Coração
Aracaju, Brazil
Santa Casa de Belo Horizonte
Belo Horizonte, Brazil
Centro de Pesquisa do Hospital Evangelico de Belo Horizonte
Belo Horizonte, Brazil
Universidade Estadual Paulista "Julio De Mesquita Filho"
Botucatu, Brazil
Hospital Universitário São Francisco na Providência de Deus
Bragança Paulista, Brazil
CEG - Centro de Endocrinologia Geloneze
Campinas, Brazil