AzTrials
AzTrials

Kidney Disease, ChronicPhase 3NCT06531824

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

A Phase 3 study testing BI 690517 and Empagliflozin in people with Kidney Disease, Chronic, run by Boehringer Ingelheim at 562 sites in 20 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Disease, Chronic
What is being tested?
BI 690517 and Empagliflozin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
8,371 participants
Where
562 sitesin 20 countries
Study dates
30 Aug 2024to 31 Dec 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Evidence of chronic kidney disease (CKD) at risk of kidney disease progression is defined on the basis of local laboratory results recorded at least 3 months before and at the time of the Screening visit, and requires:
  • Chronic Kidney Disease Epidemiology 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) ≥150 mg/g (or protein-to-creatinine ratio ≥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 (ASi) or Mineralocorticoid Receptor Antagonist (MRA), nor that such treatment is definitely inappropriate.

Who cannot join

  • Blood potassium of >5.2 mmol/L at screening visit
  • Blood Alanine Transaminase (ALT) or Aspartate Transaminase (AST) >3x Upper Limit of Normal (ULN) at Screening visit (only one is required, with ALT preferred)
  • Known liver cirrhosis
  • On dialysis, functioning kidney transplant, or scheduled living donor transplant
  • Treated with new immunosuppression therapy for new (or relapse/flare of pre-existing) kidney disease within the last 60 days
  • Receiving more than one Renin-Angiotensin System (RAS) inhibitor (i.e. on dual therapy with two of an Angiotensin-Converting Enzyme inhibitor (ACEi), Angiotensin Receptor Blocker (ARB) or direct renin inhibitor)
  • Currently treated with an Mineralocorticoid Receptor Antagonist (MRA) (e.g. spironolactone, eplerenone, finerenone)
  • Currently treated with systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) Further exclusion criteria apply.

Trial locations and contacts

562 sites in 20 countries.

562 sites in 20 countries

United Kingdom71 sites

  • Antrim Area Hospital

    Antrim, BT41 2RL

  • Basildon Hospital

    Basildon, SS16 5NL

  • Ulster Hospital

    Belfast, BT16 1RH

  • Beltfast City Hospital

    Belfast, BT9 7AB

  • Fernley Medical Centre

    Birmingham, B11 4AN

  • Queen Elizabeth Hospital Birmingham

    Birmingham, B15 2WB

  • Burbury Medical Centre

    Birmingham, B19 1TT

  • West Heath Surgery

    Birmingham, B31 3HB

  • Ridgacre House Surgery

    Birmingham, B32 2TJ

  • Oakenhurst Medical Practice

    Blackburn, BB2 1AX

  • Royal County Sussex Hospital

    Brighton, BN2 1ES

  • Southmead Hospital

    Bristol, BS10 5NB

  • Pioneer Ridingleaze

    Bristol, BS11 0QE

  • Lawrence Hill Health Centre

    Bristol, BS2 0AN

  • Coniston Medical Practice

    Bristol, BS34 5TF

  • West Suffolk Hospital

    Bury St Edmunds, IP33 2QZ

  • Broomfield Hospital

    Chelmsford, CM1 7ET

  • Hathaway Medical Centre

    Chippenham, SN14 6GT

  • Clevedon Medical Centre

    Clevedon, BS21 6DG

  • Queen Alexandra Hospital

    Cosham, PO6 3LY

  • Daisy Hill Hospital

    County Down, BT35 8DR

  • University Hospital Coventry

    Coventry, CV2 2DX

  • The Village Surgery

    Cramlington, NE23 6US

  • Orchard Court Surgery

    Darlington, DL3 6HZ

  • Darent Valley Hospital

    Dartford, DA2 8DA

  • Dorset County Hospital

    Dorchester, DT1 2JY

  • Russells Hall Hospital

    Dudley, DY1 2HQ

  • University Health Centre

    Durham, DH1 3JX

  • Highland Clinical Research Facility

    Fulwood, PR2 9HT

  • Woodlands Family Practice

    Gillingham, ME7 2BU

  • Gloucestershire Royal Hospital

    Gloucester, GL1 3NN

  • James Paget University Hospital

    Great Yarmouth, NR31 6LA

  • The Garth Surgery

    Guisborough, TS14 7DJ

  • Hereford County Hospital

    Hereford, HR1 2BN

  • Ipswich Hospital (UK)

    Ipswich, IP4 5PD

  • The Queen Elizabeth Hospital

    Kings Lynn, PE30 4ET

  • Pinfold Surgery

    Leeds, LS26 9AA

  • Ryeland Surgery

    Leominster, HR6 8HD

  • St Luke's Hospital

    Little Horton Lane, BD5 0NA

  • Aintree University Hospital

    Liverpool, L9 7AL

  • North Middlesex University Hospital

    London, N18 1QX

  • Guy's Hospital

    London, SE1 9RT

  • King's College Hospital

    London, SE5 9RS

  • St George's Hospital

    London, SW17 0QT

  • Hammersmith Hospital

    London, W12 0HS

  • Richford Gate Medical Practice

    London, W6 7HY

  • Altnagelvin Area Hospital

    Londonderry, BT47 6SB

  • Arrowe Park Hospital

    Metropolitan Borough of Wirral, CH49 5PE

  • Linthorpe Surgery

    Middlesbrough, TS5 6HA

  • Norfolk and Norwich University Hospital

    Norfolk, NR4 7UY

  • Northampton General Hospital

    Northampton, NN1 5BD

  • Banbury Cross Health Centre

    Oxford, OX16 9AD

  • Churchill Hospital

    Oxford, OX3 7LE

  • St Bartholomews & Hollow Way Med Centre

    Oxford, OX4 1XB

  • Pickering Medical Practice

    Pickering, YO18 8BL

  • Lilliput Surgery

    Poole, BH14 8EE

  • Royal Berkshire Hospital

    Reading, RG1 5AN

  • Alexandra Hospital

    Redditch, B98 7UB

  • Salford Royal Hospital

    Salford, M6 8HD

  • Royal Shrewsbury Hospital

    Shrewsbury, SY3 8XQ

  • St Helens Hospital

    St Helens, WA9 3DA

  • Lister Hospital

    Stevenage, SG1 4AB

  • Great Western Hospital

    Swindon, SN3 6BB

  • Royal Cornwall Hospital

    Truro, TR1 3LJ

  • Church Street Practice

    Wantage, OX12 9BN

  • Southend University Hospital

    Westcliff-on-Sea, SS0 0RY

  • 168 Parklands Medical Centre

    Weston-super-Mare, BS24 7PR

  • Estuary View Medical Centre

    Whitstable, CT5 3SE

  • Windrush Medical Practice

    Witney, OX28 6JS

  • Eynsham Medical Centre

    Witney, OX29 4QB

  • Woodthorpe Surgery

    York, YO24 2RQ

Other trials in United Kingdom

China59 sites

  • Ansteel Group General Hospital

    Anshan, 114000

  • Beijing AnZhen Hospital, Capital Medical University

    Beijing, 100029

  • Peking University Third Hospital

    Beijing, 100029

  • Fuwai Hospital, CAMS&PUMC

    Beijing, 100037

  • Heping Hospital Affiliated to Changzhi Medical College

    Changzhi, 046000

  • The Second Hospital of Chaoyang

    Chaoyang, 122000

  • Affiliated Hospital of Chengdu University

    Chengdu, 610041

  • West China Fourth Hospital of Sichuan University

    Chengdu, 610041

  • Affiliated Hospital of Chifeng University

    Chifeng, 024000

  • The Affiliated Yongchuan Hospital of Chongqing Medical University

    Chongqing, 402160

  • Gaoming People's Hospital

    Foshan, 528500

  • Linquan County People's Hospital

    Fuyang, 236400

  • Gaozhou People's Hospital

    Gaozhou, 525200

  • Guangzhou First People's Hospital

    Guangzhou, 510180

  • Guangzhou Red Cross Hospital

    Guangzhou, 510240

  • The Third Affiliated Hospital of Southern Medical University

    Guangzhou, 510665

  • The Fifth Affiliated Hospital of Southern Medical University

    Guangzhou, 510925

  • Guangdong Provincial Hospital of Chinese Medicine

    Guangzhou, 528200

  • Hainan General Hospital

    Haikou, 570311

  • Shulan(Hanghzhou) Hospital

    Hanghzhou, 310022

  • Zhejiang Hospital

    Hangzhou, 310030

  • The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine

    Harbin, 150001

  • The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine

    Harbin, 150066

  • The Second People's Hospital of Hefei

    Hefei, 230011

  • International Mongolian Hospital of Inner Mongolia

    Hohot, 010010

  • Huangshi Central Hospital

    Huangshi, 435000

  • Jingzhou Central Hospital

    Jingzhou, 434020

  • Henan Jiyuan People's Hospital

    Jiyuan, 454650

  • Liuzhou People's Hospital

    Liuzhou, 545006

  • Oriental Hospital

    Luoyang, 471000

  • Luoyang Third People's Hospital

    Luoyang, 471002

  • Luoyang Central Hospital

    Luoyang, 471009

  • Luoyang Yanshi People's Hospital

    Luoyang, 471900

  • Meishan People's Hospital

    Meishan, 620010

  • Jiangxi Branch Hospital of Xiangya Hospital of Central South University

    Nanchang, 330000

  • Qingdao Cardiovascular Hospital

    Qingdao, 266034

  • Shanghai Tenth People's Hospital

    Shanghai, 200072

  • Shantou Central Hospital

    Shantou, 515031

  • Second Hospital Affiliated to Shantou Medical University

    Shantou, 515041

  • Shaoguan First People's Hospital

    Shaoguan, 512000

  • Shaoxing Second Hospital

    Shaoxing, 312000

  • Shenzhen Nanshan People's Hospital

    Shenzhen, 518052

  • The Seventh Affiliated Hospital, Sun Yat-sen University

    Shenzhen, 518107

  • Shijiazhuang People's Hospital

    Shijiazhuang, 050011

  • Songyuan Jilin Oilfield Hospital

    Songyuan, 138000

  • Taizhou Hospital of Zhejiang Province

    Taizhou, 317000

  • The Fourth Central Hospital of Tianjin

    Tianjin, 300140

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, 830054

  • Wuhan Fourth Hospital

    Wuhan, 430000

  • Hubei Provincial Hospital of Integrated Traditional Chinese and Western Medicine

    Wuhan, 430015

  • Xiamen Cardiovascular Hospital Xiamen University

    Xiamen, 361006

  • Xinxiang Central Hospital

    Xinxiang, 453000

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang, 453100

  • The First Affiliated Hospital of Hebei North University

    Zhangjiakou, 075000

  • The Ninth People's Hospital of Zhengzhou

    Zhengzhou, 450053

  • Zhuhai People's Hospital

    Zhuhai, 519000

  • Zhumadian Central Hospital

    Zhumadian, 463000

  • Zhuzhou Central Hospital

    Zhuzhou, 412000

  • Zhuzhou Central Hospital

    Zhuzhou, 412007

Other trials in China

India54 sites

  • Manipal Hospitals, Old Airport Road

    Bangalore, 560017

  • St John's Medical College

    Bangalore, 560034

  • Apollo Hospital - Bangalore

    Bangalore, 560076

  • All India Institute of Medical Sciences, Bathinda

    Bathinda, 151001

  • Apollo Hospitals - Bhubaneswar

    Bhubaneswar, 751005

  • All India Institute of Medical Sciences Bhubaneswar

    Bhubaneswar, 751019

  • All India Institute of Medical Sciences, Bilaspur

    Bilāspur, 174001

  • Post Graduate Institute of Medical Education and Research

    Chandigarh, 160012

  • Apollo Hospital - Chennai

    Chennai, 600006

  • Apollo Speciality Hospitals, Vanagaram

    Chennai, 600095

  • Aakash Healthcare Super Speciality Hospital

    Dwārka, 110075

  • Accord Superspeciality Hospital

    Faridabad, 121002

  • Amrita Hospital Faridabad

    Faridabad, 121002

  • Marengo Asia Hospitals, Guhugram

    Guhugram, 122011

  • Vedenta Hospitals

    Guntur, 522001

  • Artemis Hospital

    Gurugram, 122001

  • Karnataka Institute of Medical Sciences, Hubli

    Hubli, 580021

  • Osmania Medical College & Hospital

    Hyderabad, 500012

  • Apollo Hospitals Jubilee Hills

    Hyderabad, 500033

  • Apollo DRDO Hospital

    Hyderabad, 500058

  • Nizam's Institute of Medical Sciences

    Hyderabad, 500082

  • Fortis Hospital, Jalandhar

    Jalandhar, 144012

  • All India Institute of Medical Sciences, Jodhpur

    Jodhpur, 342005

  • Amrita Institute of Medical Sciences and Research Centre

    Kochi, 682041

  • Nil Ratan Sircar Medical College & Hospital

    Kolkata, 700014

  • Manipal Hospitals, EM Bypass

    Kolkata

  • IQRAA International hospital & research centre.

    Kozhikode, 673009

  • King George's Medical University

    Lucknow, 226003

  • Dr Ram Manohar Lohia Institute of Medical Sciences

    Lucknow, 226010

  • Sanjay Gandhi Post Graduate Institute of Medical Sciences

    Lucknow, 226014

  • Meenakshi Mission Hospital & Research Centre

    Madurai, 625107

  • Apollo Speciality Hospital

    Madurai, K.K. Nagar, 625020

  • Fortis Hospital, Manesar

    Mānesar, 122052

  • Kasturba Medical College and Hospital

    Mangaluru, 575001

  • Apollo BGS Hospital

    Mysore, 570023

  • Muljibhai Patel Urological Hospital

    Nadiād, 387001

  • Max Super Specialty Hospital, Saket

    New Delhi, 110017

  • Epitome Kidney Urology Institute and Lions Hospital

    New Delhi, 110025

  • Maharaja Agrasen Hospital

    New Delhi, 110026

  • All India Institute of Medical Sciences

    New Delhi, 110029

  • Fortis Flt. Lt. Rajan Dhall Hospital

    New Delhi, 110070

  • Venkateshwar Hospital

    New Delhi, 110075

  • Indira Gandhi Institute of Medical Sciences

    Patna, 800014

  • Jawaharlal Institute of Postgraduate Medical Education

    Puducherry, 605006

  • DKS Post Graduate Institute & Research Center, Raipur (C.G)

    Raipur, 492001

  • All India Institute of Medical Sciences

    Raipur, 492099

  • Raj Hospitals

    Ranchi, 834001

  • Paras HEC, Ranchi

    Ranchi, 834004

  • Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences

    Rohtak, 124001

  • Yashoda Hospitals - Secunderabad

    Secunderabad, 500003

  • Kimshealth

    Trivandrum, 695029

  • Aman Hospital & Research Center

    Vadodara, 390021

  • Christian Medical College, Vellore

    Vellore, 632517

  • Apollo Hospitals Health City

    Visakhapatnam, 530040

Other trials in India

United States53 sites

  • UNM Health Science Center

    Albuquerque, New Mexico, 87106

  • Emory University School of Medicine

    Atlanta, Georgia, 30322

  • Research Management, Inc - Austin

    Austin, Texas, 78751

  • Medstar Health Research Institute

    Baltimore, Maryland, 21239

  • National Heart Institute

    Beverly Hills, California, 90211

  • Flourish Research

    Boca Raton, Florida, 33434

  • Advanced Heart Care, LLC

    Bridgewater, New Jersey, 08807

  • Southwest Mississippi Nephrology, Pllc

    Brookhaven, Mississippi, 39601-2326

  • Metrolina Nephrology Associates, PA

    Charlotte, North Carolina, 28208-0014

  • Metrolina Nephrology Associates, PA

    Charlotte, North Carolina, 28277

  • University of Virginia Health System

    Charlottesville, Virginia, 22903

  • Northwestern University

    Chicago, Illinois, 60611

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Kootenai Research Services

    Coeur d'Alene, Idaho, 83814

  • Joseph Maxwell Cleland Atlanta VA Medical Center

    Decatur, Georgia, 30033-4004

  • Dallas Nephrology Associates Medical Clinic

    DeSoto, Texas, 75115-2011

  • Nephrology Associates, Inc

    East Providence, Rhode Island, 02914-2641

  • Academy Of Diabetes, Thyroid And Endocrine, PA

    El Paso, Texas, 79935

  • University of Florida Health Shands Hospital

    Gainesville, Florida, 32608

  • Carolina Kidney Associates

    Greensboro, North Carolina, 27405-3654

  • Apogee Clinical Research

    Huntsville, Alabama, 35805-4104

  • Florida Kidney Physicians LLC

    Jacksonville Beach, Florida, 32250-4303

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • South Denver Cardiology Associates

    Littleton, Colorado, 80120

  • University of Louisville

    Louisville, Kentucky, 40202

  • P&I Clinical Research, LLC

    Lufkin, Texas, 75904

  • Texas Institute for Kidney and Endocrine Disorders

    Lufkin, Texas, 75904

  • East Coast Institute For Research LLC

    Macon, Georgia, 31210-1359

  • Kidney and Hypertension Specialists, PLLC

    Manassas, Virginia, 20110

  • University of Tennessee

    Memphis, Tennessee, 38104

  • Total Research Group, LLC

    Miami, Florida, 33126

  • Bioresearch Partner

    Miami, Florida, 33127

  • Minneapolis VA Health Care System

    Minneapolis, Minnesota, 55417

  • VA New York Harbor Healthcare System

    New York, New York, 10010-5011

  • Tidewater Physicians Multispecialty Group

    Newport News, Virginia, 23606

  • VA Southern Nevada Healthcare System

    North Las Vegas, Nevada, 89086

  • Great Plains Nephrology

    North Platte, Nebraska, 69101-0614

  • Renal Specialists of Houston, PA

    Pasadena, Texas, 77504-1944

  • Northeast Endocrine Metabolic Associates

    Philadelphia, Pennsylvania, 19114-1028

  • Temple University

    Philadelphia, Pennsylvania, 19140

  • Seacoast Kidney and Hypertension Specialists

    Portsmouth, New Hampshire, 03801

  • Sierra Nevada Specialty Care

    Reno, Nevada, 89511

  • Lake Michigan Nephrology

    Saint Joseph, Michigan, 49085-8511

  • Salem VA Medical Center

    Salem, Virginia, 24153

  • University Health

    San Antonio, Texas, 78207

  • St. Clair Nephrology Research, LLC

    Shelby, Michigan, 48315

  • Providence Medical Research Center

    Spokane, Washington, 99204

  • Southwest Kidney Institute

    Surprise, Arizona, 85374-4840

  • Olive View - UCLA Medical Cente

    Sylmar, California, 91342

  • Clinical Renal Associates

    Upland, Pennsylvania, 19013

  • Interventional Cardiology Medical Group

    West Hills, California, 91307

  • Kansas Nephrology Research Institute, LLC

    Wichita, Kansas, 67214

  • Brookview Hills Research Associates LLC

    Winston-Salem, North Carolina, 27103

Other trials in United States

Germany52 sites

  • Universitätsklinikum Aachen, AöR

    Aachen, 52074

  • KfH-Nierenzentrum Bad Kreuznach

    Bad Kreuznach, 55543

  • Nephrologische Gemeinschaftspraxis Bad Nenndorf

    Bad Nenndorf, 31542

  • Herz- und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen

    Bad Oeynhausen, 32545

  • Vivantes Klinikum im Friedrichshain

    Berlin, 10249

  • Praxis für Nierenkrankheiten und Dialyse Helle Mitte

    Berlin, 12627

  • Universitätsklinikum Bonn AöR

    Bonn, 53127

  • Städtisches Klinikum Braunschweig gGmbH

    Braunschweig, 38126

  • St.-Josefs-Hospital Cloppenburg

    Cloppenburg, 49661

  • KfH Nierenzentrum Coburg

    Coburg, 96450

  • Klinikum Dortmund gGmbH

    Dortmund, 44137

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225

  • Dialysezentrum Elsenfeld

    Elsenfeld, 63820

  • ClinPhenomics CVC GmbH

    Frankfurt, 60596

  • Agaplesion Markus Krankenhaus

    Frankfurt am Main, 60431

  • Universitätsklinikum Frankfurt

    Frankfurt am Main, 60596

  • Nierenzentrum Freiburg

    Freiburg im Breisgau, 79100

  • Universitätsklinikum Gießen und Marburg GmbH

    Giessen, 35392

  • Universitätsmedizin Greifswald

    Greifswald, 17489

  • Universitätsklinikum Halle (Saale) AöR

    Halle, 06097

  • Universitätsklinikum Hamburg, Eppendorf

    Hamburg, 20246

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Zentrum Für Nieren Hochdruck und Stoffwechselerkrankungen

    Hanover, 30625

  • BAG für Nephrologie und Dialyse

    Heilbronn, 74076

  • Ruhr-Universität Bochum

    Herne, 44625

  • Universität des Saarlandes

    Homburg, 66421

  • Universitätsklinikum Jena

    Jena, 07747

  • Universitätsklinikum Schleswig-Holstein, Campus Kiel

    Kiel, 24105

  • Klinikum Konstanz

    Konstanz, 78464

  • KfH-Nierenzentrum Kronach

    Kronach, 96317

  • Dr. Vehling-Kaiser MVZ GmbH

    Landshut, 84036

  • KfH Nierenzentrum Leipzig

    Leipzig, 04129

  • Nephrologisches Zentrum Emsland

    Lingen, 49808

  • Otto-von-Guericke-Universität Magdeburg

    Magdeburg, 39120

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55131

  • Klinikum der Universität München - Campus Innenstadt

    München, 80336

  • Klinikum rechts der Isar der Technischen Universität München

    München, 81675

  • Dialysezentrum Neckarsulm

    Neckarsulm, 74172

  • Universitätsklinikum Ruppin-Brandenburg

    Neuruppin, 16816

  • Klinikum Nürnberg

    Nuremberg, 90471

  • Universitätsmedizin Rostock

    Rostock, 18057

  • Dialysezentrum Rotenburg

    Rotenburg (Wümme), 27356

  • MVZ Dialysezentrum Schweinfurt

    Schweinfurt, 97421

  • Städtisches Klinikum Solingen gGmbH

    Solingen, 42653

  • Nephrologische Gemeinschaftspraxis Springe

    Springe, 31832

  • Robert-Bosch-Krankenhaus GmbH

    Stuttgart, 70376

  • KfH-Nierenzentrum Traunstein

    Traunstein, 83278

  • Medizinisches Versorgungszentrum der Barmherzigen Brüder Trier gGmbH

    Trier, 54292

  • Nephrologisches Zentrum Villingen-Schwenningen

    Villingen-Schwenningen, 78052

  • Nierenzentrum Wiesbaden

    Wiesbaden, 65191

  • Helios Universitätsklinikum Wuppertal

    Wuppertal, 42283

  • Universitätsklinikum Würzburg AÖR

    Würzburg, 97078

Other trials in Germany

Brazil32 sites

  • Centro de Pesquisa Clínica do Coração

    Aracaju, 49055-530

  • Santa Casa de Belo Horizonte

    Belo Horizonte, 30150-320

  • Centro de Pesquisa do Hospital Evangelico de Belo Horizonte

    Belo Horizonte, 30220-330

  • Universidade Estadual Paulista "Julio De Mesquita Filho"

    Botucatu, 18618-686

  • Hospital Universitário São Francisco na Providência de Deus

    Bragança Paulista, 1291-6542

  • CEG - Centro de Endocrinologia Geloneze

    Campinas, 13073-350

  • Instituto Cardiovascular de Linhares Ltda

    Centro Linhares, 29900010

  • PUC Trials - Núcleo de Pesquisa Clínica da Escola de Medicina da PUC-PR

    Curitiba, 80230-130

  • Hospital Universitário Walter Cantidio - UFC

    Fortaleza, 60416-000

  • Centro de Pesquisas em Diabetes e Doencas Metabolicas

    Fortaleza, 60430-350

  • Clínica CENDI Endocrinologia e Diabetes

    Goiânia, 74230-035

  • Hospital Ruy Azeredo

    Goiânia, 74453200

  • Fundação Pró-Rim Joinville

    Joinville, 89227-680

  • Galileo Medical Research Ltda

    Juiz de Fora, 36033-318

  • Centro de Pesquisas Clínicas Dr. Marco Mota

    Maceió, 57051-160

  • Hospital Universitário Onofre Lopes

    Natal, 59012300

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, 90035-903

  • Hospitalar Moinhos de Vento

    Porto Alegre, 90560-032

  • Hospital Sao Lucas da PUCRS

    Porto Alegre, 90610-000

  • IMIP Pernambuco

    Recife, 50070902

  • AME Saúde

    Recife, 50720110

  • Hospital das Clinicas da Universidade Federal de Pernambuco

    Recife, 50740900

  • Fundação Bahiana de Infectologia

    Salvador, 40110160

  • CEMEC - Centro Multidisciplinar de Estudos Clínicos

    São Bernardo do Campo, 09715-090

  • Hospital de Base

    São José do Rio Preto, 15090-000

  • CIPES - Centro Internacional de Pesquisa Clínica

    São José dos Campos, 12230-001

  • Instituto de Assistência Médica ao Servidor Público Estadual de São Paulo

    São Paulo, 0402-9001

  • Fundacao Oswaldo Ramos (Hospital do Rim)

    São Paulo, 04023900

  • Hospital das Clinicas da Faculdade de Medicina da USP

    São Paulo, 05403-000

  • Hospital Universitário da Universidade Federal do Piauí

    Teresina, 64049550

  • Hospital Universitário Cassiano Antônio Moraes

    Vitória, 29043-260

  • Clínica Cardiológica

    Votuporanga, 15505-189

Other trials in Brazil

Italy32 sites

  • Ospedale SS. Antonio e Biagio e C. Arrigo - AOUAL

    Alessandria, 15121

  • Asti-Ospedale Cardinal Massaia

    Asti, 14100

  • Azienda Universitaria Ospedaliera Consorziale Policlinico Bari

    Bari, 70124

  • ASST Papa Giovanni XXIII

    Bergamo, 24127

  • Policlinico S. Orsola-Malpighi

    Bologna, 40138

  • Azienda Ospedaliera ARNAS G. Brotzu

    Cagliari, 09100

  • Chieri-Ospedale Maggiore

    Chieri, 10023

  • Ospedale SS Annunziata

    Chieti, 66100

  • A.S.O. S. Croce e Carle

    Cuneo, 12100

  • Firenze-Ospedale San Giovanni di Dio

    Florence, 50124

  • A. O. Universitaria Careggi

    Florence, 50134

  • Azienda Ospedaliera San Martino

    Genova, 16132

  • Ospedale di Imola S. Maria della Scaletta

    Imola, 40026

  • Ospedale San Raffaele S.r.l.

    Milan, 20132

  • Asst Santi Paolo E Carlo

    Milan, 20142

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, 20900

  • Ospedale Maggiore della Carità

    Novara, 28100

  • Azienda Ospedaliera di Padova

    Padova, 35128

  • Azienda Ospedaliera Unversitaria di Parma

    Parma, 43126

  • Fondazione Salvatore Maugeri

    Pavia, 27100

  • Azienda Ospedaliera di Perugia

    Perugia, 06129

  • Azienda Ospedaliera Universitaria Pisana

    Pisa, 56126

  • Prato-Ospedale Santo Stefano

    Prato, 59100

  • Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza

    Roma, 00189

  • Azienda Socio Sanitaria Territoriale Lariana

    San Fermo della Battaglia, 22020

  • IRCCS Ospedale "Casa Sollievo della Sofferenza"

    San Giovanni Rotondo (Foggia), 71013

  • Azienda Socio Sanitaria Ligure 2

    Savona, 17100

  • IRCCS MultiMedica

    Sesto San Giovanni, 20099

  • Todi-Nuovo Ospedale Media Valle del Tevere

    Todi, 06059

  • Torino-Ospedale Oftalmico

    Turin, 0100

  • Ospedale Castelli - Verbania

    Verbania, 28922

  • Ospedale San Bortolo

    Vicenza, 36100

Other trials in Italy

Malaysia26 sites

  • Hospital Ampang

    Ampang, 68000

  • Hospital Selayang

    Batu Caves, 68100

  • Hospital Sultanah Nora Ismail

    Batu Pahat, 83000

  • Hospital Pulau Pinang-Pulau Pinang-21953

    George Town, 10990

  • Hospital Raja Permaisuri Bainun

    Ipoh, 30450

  • Hospital Sultanah Aminah

    Johor Bahru, 80100

  • Hospital Sultan Ismail

    Johor Bahru, 81100

  • Hospital Sultan Idris Shah Serdang

    Kajang, 43000

  • Hospital Kajang

    Kajang, Selangor, 43000

  • Hospital Tengku Ampuan Rahimah

    Klang, 41200

  • Hospital Raja Perempuan Zainab II

    Kota Bharu, 15586

  • Hospital Queen Elizabeth

    Kota Kinabalu, 88586

  • Hospital Kuala Lumpur

    Kuala Lumpur, 50586

  • University Malaya Medical Centre

    Kuala Lumpur, 59100

  • Hospital Tuanku Ampuan Najihah

    Kuala Pilah, 72000

  • Hospital Tengku Ampuan Afzan

    Kuantan, 25100

  • Hospital Umum Sarawak

    Kuching, 93586

  • Hospital Kulim

    Kulim, 09090

  • Hospital Melaka

    Malacca, 75400

  • Hospital Pakar Sultanah Fatimah

    Muar town, 84000

  • Hospital Seberang Jaya

    Perai, 13700

  • Hospital Sultan Abdul Aziz Shah

    Serdang, 43400

  • Hospital Tuanku Ja'afar

    Seremban, 70300

  • Hospital Taiping

    Taiping

  • Hospital Teluk Intan

    Teluk Intan, 36000

  • Hospital Sultan Haji Ahmad Shah

    Temerluh, 28000

Other trials in Malaysia

Japan25 sites

  • Asahikawa Medical University Hospital

    Asahikawa-Shi, 078-8510

  • Chiba University Hospital

    Chiba, 260-8677

  • University of Yamanashi Hospital

    Chuo-Shi, 409-3898

  • Kyushu University Hospital

    Fukuoka, 812-8582

  • Tokai University Hospital

    Isehara, 259-1193

  • Shimane University Hospital

    Izumo, 693-8501

  • Kawasaki Medical School Hospital

    Kurashiki-Shi, 701-0192

  • Kurume University Hospital

    Kurume, 830-0011

  • Kyoto University Hospital

    Kyoto, 606-8507

  • Aichi Medical University Hospital

    Nagakute, 480-1195

  • Chubu Rosai Hospital

    Nagoya, 455-8530

  • Nagoya University Hospital

    Nagoya, 466-8560

  • Okayama University Hospital

    Okayama, 700-8558

  • Kansai Electric Power Hospital

    Osaka, 553-0003

  • Shiga University of Medical Science Hospital

    Ōtsu, 520-2192

  • Tohoku University Hospital

    Sendai, 980-8547

  • St. Luke's International Hospital

    Tokyo, 104-8560

  • Toranomon Hospital

    Tokyo, 105-8470

  • Juntendo University Hospital

    Tokyo, 113-8431

  • The University of Tokyo Hospital

    Tokyo, 113-8655

  • Keio University Hospital

    Tokyo, 160-8582

  • National Center for Global Health and Medicine

    Tokyo, 162-8655

  • Teikyo University Hospital

    Tokyo, 173-8606

  • Tokyo-Eki Center-building Clinic

    Tokyo, Chuo-ku, 103-0027

  • Yokohama City University Hospital

    Yokohama, 236-0004

Other trials in Japan

Canada24 sites

  • Centricity Research (Brampton)

    Brampton, Ontario, L6S 0C6

  • Centricity Research (Vaughan)

    Concord, Ontario, L4K 4M2

  • University of Alberta Hospital (University of Alberta)

    Edmonton, Alberta, T6G 2P4

  • Centre for Clinical Research

    Halifax, Nova Scotia, B3H 1V7

  • Royal Inland Hospital

    Kamloops, British Columbia, V2C 2T1

  • Kelowna General Hospital

    Kelowna, British Columbia, V1Y 1T2

  • Queen's University

    Kingston, Ontario, K7L 3N6

  • London Regional Cancer Program - London Health Sciences Ctr.

    London, Ontario, N6A 5W9

  • CIUSSS de l'Est-de-l'Île-de-Montréal

    Montreal, Quebec, H1T 2M4

  • McGill University Health Centre (MUHC)

    Montreal, Quebec, H3G 1A4

  • Centre hospitalier de l'Université de Montréal (CHUM)

    Montreal, H2X 0A9

  • Lakeridge Health Oshawa

    Oshawa, Ontario, L1G 2B9

  • The Ottawa Hospital

    Ottawa, Ontario, K1H 7W9

  • Northern Health

    Prince George, British Columbia, V2M 1S2

  • CIUSSS Nord de l'île de Montreal

    Québec, Montréal, H4J 1C5

  • CHU de Quebec-Universite Laval Research Centre

    Québec, G1R 2J6

  • Diex Recherche Québec

    Québec, G1V 4T3

  • CIUSSS de l Estrie-CHUS

    Sherbrooke, Quebec, J1H 5N4

  • Fraser Health

    Surrey, British Columbia, V3W 1J8

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4G 3E8

  • St. Michael's Hospital

    Toronto, Ontario, M5C2T2

  • Toronto General Hospital

    Toronto, Ontario, M5G 2N2

  • St. Paul's Hospital (Vancouver)

    Vancouver, British Columbia, V1Y 1S1

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Mexico20 sites

  • Centenario Hospital Miguel Hidalgo

    Aguascalientes, 20259

  • Instituto de Diabetes, Obesidad y Nutrición S.C.

    Cuernavaca, 62250

  • Neurociencias Estudios Clinicos S.C.

    Culiacán, CP 80020

  • Instituto de investigación aplicado a la neurociencia

    Durango, 34000

  • Centro de Investigacion Clinica y Medicina Traslacional (CIMeT)

    Guadalajara, 44340

  • Centro Medico Nacional de Occidente/ Centro De Investigacion Biomedica De Occidente

    Guadalajara, 44340

  • Unidad de Investigación Clinica y Atencion Medica HEPA SC

    Guadalajara, 44670

  • Medical Care & Research SA de CV

    Mérida, 97070

  • Merida Investigación Clínica

    Mérida, 97125

  • Health Pharma Professional Research S.A. de C.V.

    Mexico City, 03100

  • Soluciones Terapéuticas Médico Quirúrgicas S. de R.L. de C.V.

    Mexico City, 03650

  • Hospital Juárez de México

    Mexico City, 07760

  • Iecsi S.C.

    Monterrey, 64310

  • Hospital Universitario Dr Jose Eleuterio Gonzalez

    Monterrey, 64460

  • Renall Monterrey

    Monterrey, CP 64040

  • Centro de Investigación Clínica Chapultepec S.A. de C.V.

    Morelia, 58260

  • IMSS Regional General Hospital 180

    Tlajomulco de Zúñiga, 45653

  • Instituto Nacional de Cardiologia Ignacio Chavez

    Tlalpan, 14080

  • FAICIC S de RL de C.V.

    Veracruz, 91900

  • Sociedad de Metabolismo y Corazón S.C.

    Veracruz, 91910

Other trials in Mexico

Taiwan20 sites

  • E-Da Hospital

    Kaohsiung City, 824005

  • Lotung Poh-Ai Hospital

    Luodong Township, 265

  • Far Eastern Memorial Hospital

    New Taipei City, 220

  • Taipei Tzu Chi Hospital

    New Taipei City, 23142

  • Taipei Medical University-Shuang Ho Hospital

    New Taipei City, 23561

  • Fu Jen Catholic University Hospital

    New Taipei City, 243089

  • Chung Shan Medical University Hospital

    Taichung, 402

  • China Medical University Hospital

    Taichung, 404

  • Taichung Veterans General Hospital

    Taichung, 407219

  • Tungs' Taichung MetroHarbor Hospital

    Taichung, 435

  • National Cheng Kung University Hospital

    Tainan, 70403

  • Chi Mei Hospital, Liouying

    Tainan, 736402

  • Mackay Memorial Hospital

    Taipei, 10449

  • Cathay General Hospital

    Taipei, 106

  • Taipei Medical University Hospital

    Taipei, 110

  • Shin Kong Wu Ho-Su Memorial Hospital

    Taipei, 111045

  • Taipei Veterans General Hospital

    Taipei, 112

  • Taipei Municipal Wanfang Hospital

    Taipei, 11696

  • TaoYuan General Hospital

    Taoyuan City, 330

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan City, 333

Other trials in Taiwan

Argentina19 sites

  • Fundacion INTECNUS

    Bariloche, 8500

  • Terapia Renal Domiciliaria

    Buenos Aires, 1407

  • Centro de Salud Renal Junin SRL

    Buenos Aires, B6000

  • Dres. Iribarren & Asoc. Consultario

    Buenos Aires, C1061AAE

  • Glenny Corp - Centro Medico Saavedra

    Buenos Aires, C1430CKE

  • CPSIC SRL - Cardiologia Palermo

    CABA, 1425

  • Sanatorio Pasteur S.A

    Catamarca, K4703AFI

  • CEMIC

    Ciudad Autonoma Buenos Aires, C1431FWO

  • CIMEL Chahin - Chahin S.A.

    Lanús Este, B1824KAJ

  • Centro Nefrologico del Mar

    Mar del Plata, B7612

  • Mains Bleues

    Rafaela, S2300

  • Hospital Privado de Rosario

    Rosario, S2000GAP

  • Sanatorio Parque S.A.

    Rosario, S2013

  • Instituto de Nefrourologia y Nutricion de Salta

    Salta, A4400

  • Clinica El Castaño

    San Juan, J5400

  • Centro de Investigaciones Medicas Tucuman

    San Miguel de Tucumán, 4000

  • Centro Integral de Medicina Respiratoria - CIMER

    San Miguel de Tucumán, 4000

  • Instituto de Investigaciones Clinicas de Rosario

    Santa Fe, 2000

  • CEREHA S.A.- Centro de Estudios Renales e Hipertension Arterial

    Villa Domínico, B1872EEB

Other trials in Argentina

Australia18 sites

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • Eastern Health-Box Hill Hospital

    Box Hill, Victoria, 3128

  • Concord Hospital

    Concord, New South Wales, 2139

  • Renal Research, Gosford

    Gosford, New South Wales, 2250

  • Austin Health

    Heidelberg Heights, Victoria, 3081

  • Nepean Hospital

    Kingswood, New South Wales, 2747

  • St George Hospital

    Kogarah, New South Wales, 2217

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • St Vincent's Hospital Melbourne

    Melbourne, Victoria, 3065

  • Macquarie University

    New South Wales, 2019

  • Westmead Hospital

    New South Wales, 2145

  • Hervey Bay Hospital

    Pialba, Queensland, 4655

  • Port Macquarie Base Hospital (PMBH)

    Port Macquarie, New South Wales, 2444

  • AOVO Clinical Trials

    Southport, Queensland, 4215

  • Griffith University

    Southport, Queensland, 4222

  • Sunshine Hospital

    St Albans, Victoria, 3021

  • Toowoomba Hospital

    Toowoomba, Queensland, 4350

Other trials in Australia

South Korea18 sites

  • Korea University Ansan Hospital

    Ansan-si, 15355

  • Pusan National University Hospital

    Busan, 49241

  • Soon Chun Hyang University Hospital Cheonan

    Cheonan-si, 31151

  • Chungbuk National University Hospital

    Cheongju-si, 28644

  • Kyungpook National University Hospital

    Daegu, 41944

  • Keimyung University Dongsan Hospital

    Deagu, 42601

  • Inje University Ilsan Paik Hospital

    Goyang-si, 10380

  • Hanyang University Guri Hospital

    Guri-si, 11923

  • Chung-Ang University Gwangmyeong Hospital

    Gwangmyeong, 14353

  • The Catholic University of Korea, Incheon St. Mary's Hospital

    Incheon, 21431

  • CHA Bundang Medical Center

    Seongnam-si, 13496

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital

    Seoul, 03722

  • Gangnam Severance Hospital

    Seoul, 06273

  • SMG-SNU Boramae Medical Center

    Seoul, 07061

  • The Catholic University of Korea, Yeouido St.Mary's Hospital

    Seoul, 07345

  • Korea University Guro Hospital

    Seoul, 08308

  • Yonsei University Wonju Severance Christian Hospital

    Wŏnju, 26426

Other trials in South Korea

Portugal14 sites

  • ULS da Região de Aveiro

    Aveiro, 3814-501

  • Centro Clínico Académico de Braga (2CA-Braga)

    Braga, 4710-243

  • CHLO, EPE - Hospital de Santa Cruz

    Carnaxide, 2790-134

  • Unidade Local de Saúde de Castelo Branco, E.P.E

    Castelo Branco, 6000-085

  • CHUC - Centro Hospitalar e Universitario de Coimbra, EPE

    Coimbra, 3004-561

  • Unidade Local de Saúde do Algarve, E.P.E

    Faro, 8000-386

  • SESARAM

    Funchal, 9004-514

  • ULS de São José

    Lisbon, 1069-166

  • Unidade Local de Saúde Santa Maria

    Lisbon, 1649-035

  • Hospital Beatriz Ângelo

    Loures, 2674-514

  • Centro Hospitalar Universitário São João,EPE

    Porto, 4200-319

  • Unidade Local de Saúde de Matosinhos

    Senhora da Hora, 4464-513

  • Unidade Local De Saude Da Arrabida E.P.E.

    Setúbal, 2910-549

  • Unidade Local De Saude De Viseu Dao-Lafoes E.P.E.

    Viseu, 3504-509

Other trials in Portugal

Denmark7 sites

  • Aalborg Universitetsshospital

    Aalborg, 9000

  • Rigshospitalet, København

    Copenhagen, 2100

  • Herlev and Gentofte Hospital

    Herlev, 2730

  • Steno Diabetes Center Copenhagen

    Herlev, 2730

  • Kolding Hospital

    Kolding, 6000

  • Odense University Hospital

    Odense, 5000

  • Zealand University Hospita; Roskilde

    Roskilde, 4000

Other trials in Denmark

New Zealand7 sites

  • Auckland City Hospital

    Auckland, 1023

  • Middlemore Hospital

    Auckland, 2025

  • North Shore Hospital

    Auckland, Takapuna, 0620

  • Dunedin Hospital

    Dunedin, Otago, 9016

  • Waikato Hospital

    Hamilton, Waikato Region, 3240

  • Taranaki Base Hospital

    New Plymouth, 4310

  • Whangarei Hospital

    Whangarei, Northland, 0110

Other trials in New Zealand

Sweden7 sites

  • Danderyds Sjukhus AB

    Danderyd, 182 88

  • Sahlgrenska Universitetsjukhuset

    Gothenburg, 413 46

  • Universitetssjukhuset Linköping

    Linköping, 581 85

  • Skånes Universitetssjukhus, Lund

    Lund, 221 85

  • Karolinska University Hospital

    Stockholm, 14157

  • Region Vaesternorrland

    Sundsvall, 856 43

  • Akademiska sjukhuset

    Uppsala, 751 85

Other trials in Sweden

Belgium4 sites

  • AZ Sint-Jan Brugge

    Bruges, 8000

  • Ziekenhuis Oost-Limburg

    Genk, 3600

  • UZ Brussel

    Jette, 1090

  • Centre Hospitalier Universitaire de Liège

    Liège, 4000

Other trials in Belgium

About this study

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

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.

Being tested
BI 690517, Placebo matching BI 690517, Empagliflozin
Medical subject headings
Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BI 690517Drug

    Also called Vicadrostat

    BI 690517 (called Type M randomized treatment)

  • Placebo matching BI 690517Drug

    Placebo matching BI 690517

  • EmpagliflozinDrug

    Empagliflozin (called Type E)

Study groups in NCT06531824
Study groupRoleWhat they receive
Part 1: Run-in period (all participants)Other* Participant will receive empagliflozin (called Type E) together with study tablets (called Type F) prior to later randomisation to the main study treatment (Type M). * This run-in period allows empagliflozin to be established and have its effects on kidney function before randomisation, and to make sure participant can tolerate empagliflozin long-term. Participants will not routinely know whether type F treatment is active or inactive so that participants can become familiar with taking main study tablet (Type M) after randomization.
Receives: Drug: Empagliflozin
Part 2: Randomized treatment, follow-up period, treatment groupExperimentalNot described
Receives: Drug: BI 690517; Drug: Empagliflozin
Part 2: Follow-up period, placebo groupPlacebo comparatorNot described
Receives: Drug: Placebo matching BI 690517; Drug: Empagliflozin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to first occurrence of the primary composite outcome of: (i) Kidney disease progression*; or (ii) Hospitalization for heart failure; or (iii) Cardiovascular death.

    Kidney disease progression is defined as kidney failure or a sustained decline of ≥40% in estimated Glomerular Filtration Rate (eGFR) from randomization

    Measured: up to 4 years

Secondary outcomes (6)

  1. Key secondary outcome: Time to first event of kidney failure, hospitalization for heart failure or cardiovascular death

    Measured: up to 4 years

  2. Key secondary outcome: Time to first event of hospitalization for heart failure or cardiovascular death

    Measured: up to 4 years

  3. Key secondary outcome: Occurrences of hospitalizations from any cause (first and any subsequent, combined) or death from any cause

    Measured: up to 4 years

  4. Key secondary outcome: Time to death from any cause

    Measured: up to 4 years

  5. Key secondary outcome: Annual rate of change in eGFR from 1 month until last scheduled visit (i.e. chronic eGFR slope)

    Measured: up to 4 years

  6. Time to first event of kidney disease progression or cardiovascular death

    Measured: up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2024
  2. Study start30 Aug 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Part 1: Run-in period, non randomized, single arm Part 2: Randomized (BI 690517 or placebo), double-blind, placebo-controlled follow-up period
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
8,371 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06531824
Sponsor's protocol ID
1378-0006
Other IDs
2024-511025-63-00, U1111-1306-5049
Status last verified
Oct 2026
First submitted
29 Jul 2024
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BI 690517 and Empagliflozin in people with Kidney Disease, Chronic, run by Boehringer Ingelheim at 562 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 562 sites in United Kingdom, China, India, United States, Germany and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to first occurrence of the primary composite outcome of: (i) Kidney disease progression*; or (ii) Hospitalization for heart failure; or (iii) Cardiovascular death. (time frame: up to 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06531824.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.

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