EASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin) | NCT06531824 | Trialant

EASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin) | NCT06531824 | Trialant

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
Brief 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.

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Surprise, Arizona 85374-4840, United States

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Beverly Hills, California 90211, United States

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Gainesville, Florida 32608, United States

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Jacksonville Beach, Florida 32250-4303, United States

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Miami, Florida 33126, United States

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Atlanta, Georgia 30322, United States

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Chicago, Illinois 60611, United States

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Yashoda Hospitals - SecunderabadRecruiting

Secunderabad, 500003, India

KimshealthRecruiting

Trivandrum, 695029, India

Christian Medical College, VelloreRecruiting

Vellore, 632517, India

Apollo Hospitals Health CityRecruiting

Visakhapatnam, 530040, India

Ospedale SS. Antonio e Biagio e C. Arrigo - AOUALRecruiting

Alessandria, 15121, Italy

Asti-Ospedale Cardinal MassaiaRecruiting

Asti, 14100, Italy

Azienda Universitaria Ospedaliera Consorziale Policlinico BariRecruiting

Bari, 70124, Italy

ASST Papa Giovanni XXIIIRecruiting

Bergamo, 24127, Italy

Policlinico S. Orsola-MalpighiRecruiting

Bologna, 40138, Italy

Azienda Ospedaliera ARNAS G. BrotzuRecruiting

Cagliari, 09100, Italy

Chieri-Ospedale MaggioreRecruiting

Chieri, 10023, Italy

Ospedale SS AnnunziataRecruiting

Chieti, 66100, Italy

A.S.O. S. Croce e CarleRecruiting

Cuneo, 12100, Italy

Firenze-Ospedale San Giovanni di DioRecruiting

Florence, 50124, Italy

A. O. Universitaria CareggiRecruiting

Florence, 50134, Italy

Azienda Ospedaliera San MartinoRecruiting

Genova, 16132, Italy

Ospedale di Imola S. Maria della ScalettaRecruiting

Imola, 40026, Italy

Ospedale San Raffaele S.r.l.Recruiting

Milan, 20132, Italy

Asst Santi Paolo E CarloRecruiting

Milan, 20142, Italy

Fondazione IRCCS San Gerardo dei TintoriRecruiting

Monza, 20900, Italy

Ospedale Maggiore della CaritàRecruiting

Novara, 28100, Italy

Azienda Ospedaliera di PadovaRecruiting

Padova, 35128, Italy

Azienda Ospedaliera Unversitaria di ParmaRecruiting

Parma, 43126, Italy

Fondazione Salvatore MaugeriRecruiting

Pavia, 27100, Italy

Azienda Ospedaliera di PerugiaRecruiting

Perugia, 06129, Italy

Azienda Ospedaliera Universitaria PisanaRecruiting

Pisa, 56126, Italy

Prato-Ospedale Santo StefanoRecruiting

Prato, 59100, Italy

Azienda Ospedaliera Sant'Andrea-Università di Roma La SapienzaRecruiting

Roma, 00189, Italy

Ospedale Sant'Anna di San Fermo della BattagliaRecruiting

San Fermo della Battaglia, 22020, Italy

IRCCS Ospedale "Casa Sollievo della Sofferenza"Recruiting

San Giovanni Rotondo (Foggia), 71013, Italy

Azienda Sociosanitaria Ligure 2Recruiting

Savona, 17100, Italy

IRCCS MultiMedicaRecruiting

Sesto San Giovanni, 20099, Italy

Todi-Nuovo Ospedale Media Valle del TevereRecruiting

Todi, 06059, Italy

Torino-Ospedale OftalmicoRecruiting

Turin, 0100, Italy

Ospedale Castelli - VerbaniaRecruiting

Verbania, 28922, Italy

Ospedale San BortoloRecruiting

Vicenza, 36100, Italy

Asahikawa Medical University HospitalRecruiting

Asahikawa-Shi, 078-8510, Japan

Boehringer IngelheimContact

nippon@bitrialsupport.com05050508862

Chiba University HospitalRecruiting

Chiba, 260-8677, Japan

University of Yamanashi HospitalRecruiting

Chuo-Shi, 409-3898, Japan

Boehringer IngelheimContact

nippon@bitrialsupport.com05050508862

Kyushu University HospitalRecruiting

Fukuoka, 812-8582, Japan

Tokai University HospitalRecruiting

Isehara, 259-1193, Japan

Shimane University HospitalRecruiting

Izumo, 693-8501, Japan

Kawasaki Medical School HospitalRecruiting

Kurashiki-Shi, 701-0192, Japan

Boehringer IngelheimContact

nippon@bitrialsupport.com05050508862

Kurume University HospitalRecruiting

Kurume, 830-0011, Japan

Kyoto University HospitalRecruiting

Kyoto, 606-8507, Japan

Aichi Medical University HospitalRecruiting

Nagakute, 480-1195, Japan

Chubu Rosai HospitalRecruiting

Nagoya, 455-8530, Japan

Nagoya University HospitalRecruiting

Nagoya, 466-8560, Japan

Okayama University HospitalRecruiting

Okayama, 700-8558, Japan

Kansai Electric Power HospitalRecruiting

Osaka, 553-0003, Japan

Shiga University of Medical Science HospitalRecruiting

Ōtsu, 520-2192, Japan

Tohoku University HospitalRecruiting

Sendai, 980-8547, Japan

St. Luke's International HospitalRecruiting

Tokyo, 104-8560, Japan

Toranomon HospitalRecruiting

Tokyo, 105-8470, Japan

Juntendo University HospitalRecruiting

Tokyo, 113-8431, Japan

The University of Tokyo HospitalRecruiting

Tokyo, 113-8655, Japan

Keio University HospitalRecruiting

Tokyo, 160-8582, Japan

National Center for Global Health and MedicineRecruiting

Tokyo, 162-8655, Japan

Teikyo University HospitalRecruiting

Tokyo, 173-8606, Japan

Tokyo-Eki Center-building ClinicRecruiting

Tokyo, Chuo-ku, 103-0027, Japan

Boehringer IngelheimContact

nippon@bitrialsupport.com05050508862

Yokohama City University HospitalRecruiting

Yokohama, 236-0004, Japan

Hospital AmpangRecruiting

Ampang, 68000, Malaysia

Hospital SelayangRecruiting

Batu Caves, 68100, Malaysia

Hospital Sultanah Nora IsmailRecruiting

Batu Pahat, 83000, Malaysia

Hospital Pulau Pinang-Pulau Pinang-21953Recruiting

George Town, 10990, Malaysia

Hospital Raja Permaisuri BainunRecruiting

Ipoh, 30450, Malaysia

Hospital Sultanah AminahRecruiting

Johor Bahru, 80100, Malaysia

Hospital Sultan IsmailRecruiting

Johor Bahru, 81100, Malaysia

Hospital Sultan Idris Shah SerdangRecruiting

Kajang, 43000, Malaysia

Hospital KajangRecruiting

Kajang, Selangor, 43000, Malaysia

Boehringer IngelheimContact

malaysia@bitrialsupport.com1800814353

Hospital Tengku Ampuan RahimahRecruiting

Klang, 41200, Malaysia

Hospital Raja Perempuan Zainab IIRecruiting

Kota Bharu, 15586, Malaysia

Hospital Queen ElizabethRecruiting

Kota Kinabalu, 88586, Malaysia

Hospital Kuala LumpurRecruiting

Kuala Lumpur, 50586, Malaysia

University Malaya Medical CentreRecruiting

Kuala Lumpur, 59100, Malaysia

Hospital Tuanku Ampuan NajihahRecruiting

Kuala Pilah, 72000, Malaysia

Hospital Tengku Ampuan AfzanRecruiting

Kuantan, 25100, Malaysia

Hospital Umum SarawakRecruiting

Kuching, 93586, Malaysia

Hospital KulimRecruiting

Kulim, 09090, Malaysia

Hospital MelakaRecruiting

Malacca, 75400, Malaysia

Hospital Pakar Sultanah FatimahRecruiting

Muar town, 84000, Malaysia

Hospital Seberang JayaRecruiting

Perai, 13700, Malaysia

Hospital Sultan Abdul Aziz ShahRecruiting

Serdang, 43400, Malaysia

Hospital Tuanku Ja'afarRecruiting

Seremban, 70300, Malaysia

Hospital TaipingRecruiting

Taiping, Malaysia

Hospital Teluk IntanRecruiting

Teluk Intan, 36000, Malaysia

Hospital Sultan Haji Ahmad ShahRecruiting

Temerluh, 28000, Malaysia

Centenario Hospital Miguel HidalgoRecruiting

Aguascalientes, 20259, Mexico

Instituto de investigación aplicado a la neurocienciaRecruiting

Durango, 34000, Mexico

Centro de Investigacion Clinica y Medicina Traslacional (CIMeT)Recruiting

Guadalajara, 44340, Mexico

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

Guadalajara, 44340, Mexico

Unidad de Investigación Clinica y Atencion Medica HEPA SCRecruiting

Guadalajara, 44670, Mexico

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

Mexico City, 03100, Mexico

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

Mexico City, 03650, Mexico

Hospital Juárez de MéxicoRecruiting

Mexico City, 07760, Mexico

Merida Investigación ClínicaRecruiting

Mérida, 97125, Mexico

Iecsi S.C.Recruiting

Monterrey, 64310, Mexico

Hospital Universitario Dr Jose Eleuterio GonzalezRecruiting

Monterrey, 64460, Mexico

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

Morelia, 58260, Mexico

IMSS Regional General Hospital 180Recruiting

Tlajomulco de Zúñiga, 45653, Mexico

Instituto Nacional de Cardiologia Ignacio ChavezRecruiting

Tlalpan, 14080, Mexico

FAICIC S de RL de C.V.Recruiting

Veracruz, 91900, Mexico

Whangarei HospitalRecruiting

Whangarei, Northland 0110, New Zealand

Dunedin HospitalRecruiting

Dunedin, Otago 9016, New Zealand

Waikato HospitalRecruiting

Hamilton, Waikato Region 3240, New Zealand

Auckland City HospitalRecruiting

Auckland, 1023, New Zealand

Middlemore HospitalRecruiting

Auckland, 2025, New Zealand

North Shore HospitalRecruiting

Auckland, Takapuna, 0620, New Zealand

Boehringer IngelheimContact

newzealand@bitrialsupport.com0800440725

Taranaki Base HospitalRecruiting

New Plymouth, 4310, New Zealand

ULS da Região de AveiroRecruiting

Aveiro, 3814-501, Portugal

CHLO, EPE - Hospital de Santa CruzRecruiting

Carnaxide, 2790-134, Portugal

CHUC - Centro Hospitalar e Universitario de Coimbra, EPERecruiting

Coimbra, 3004-561, Portugal

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

Faro, 8000-386, Portugal

SESARAMRecruiting

Funchal, 9004-514, Portugal

ULS de São JoséRecruiting

Lisbon, 1069-166, Portugal

Unidade Local de Saúde Santa MariaRecruiting

Lisbon, 1649-035, Portugal

Hospital Beatriz ÂngeloRecruiting

Loures, 2674-514, Portugal

Centro Hospitalar Universitário São João,EPERecruiting

Porto, 4200-319, Portugal

Unidade Local de Saúde de MatosinhosRecruiting

Senhora da Hora, 4464-513, Portugal

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

Setúbal, 2910-549, Portugal

Korea University Ansan HospitalRecruiting

Ansan-si, 15355, South Korea

Pusan National University HospitalRecruiting

Busan, 49241, South Korea

Soon Chun Hyang University Hospital CheonanRecruiting

Cheonan-si, 31151, South Korea

Boehringer IngelheimContact

namhan@bitrialsupport.com0808802084

Chungbuk National University HospitalRecruiting

Cheongju-si, 28644, South Korea

Kyungpook National University HospitalRecruiting

Daegu, 41944, South Korea

Keimyung University Dongsan HospitalRecruiting

Deagu, 42601, South Korea

Boehringer IngelheimContact

namhan@bitrialsupport.com0808802084

Inje University Ilsan Paik HospitalRecruiting

Goyang-si, 10380, South Korea

Hanyang University Guri HospitalRecruiting

Guri-si, 11923, South Korea

Chung-Ang University Gwangmyeong HospitalRecruiting

Gwangmyeong, 14353, South Korea

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

Incheon, 21431, South Korea

CHA Bundang Medical CenterRecruiting

Seongnam-si, 13496, South Korea

Seoul National University HospitalRecruiting

Seoul, 03080, South Korea

Severance HospitalRecruiting

Seoul, 03722, South Korea

Gangnam Severance HospitalRecruiting

Seoul, 06273, South Korea

SMG-SNU Boramae Medical CenterRecruiting

Seoul, 07061, South Korea

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

Seoul, 07345, South Korea

Korea University Guro HospitalRecruiting

Seoul, 08308, South Korea

Yonsei University Wonju Severance Christian HospitalRecruiting

Wŏnju, 26426, South Korea

Danderyds Sjukhus ABRecruiting

Danderyd, 182 88, Sweden

Sahlgrenska UniversitetsjukhusetRecruiting

Gothenburg, 413 46, Sweden

Universitetssjukhuset LinköpingRecruiting

Linköping, 581 85, Sweden

Karolinska University HospitalRecruiting

Stockholm, 14157, Sweden

Region VaesternorrlandRecruiting

Sundsvall, 856 43, Sweden

Akademiska sjukhusetRecruiting

Uppsala, 751 85, Sweden

E-Da HospitalRecruiting

Kaohsiung City, 824005, Taiwan

Lotung Poh-Ai HospitalRecruiting

Luodong Township, 265, Taiwan

Boehringer IngelheimContact

taiwan@bitrialsupport.com0809092098

Far Eastern Memorial HospitalRecruiting

New Taipei City, 220, Taiwan

Taipei Tzu Chi HospitalRecruiting

New Taipei City, 23142, Taiwan

Taipei Medical University-Shuang Ho HospitalRecruiting

New Taipei City, 23561, Taiwan

Fu Jen Catholic University HospitalRecruiting

New Taipei City, 243089, Taiwan

Chung Shan Medical University HospitalRecruiting

Taichung, 402, Taiwan

China Medical University HospitalRecruiting

Taichung, 404, Taiwan

Taichung Veterans General HospitalRecruiting

Taichung, 407219, Taiwan

Tungs' Taichung MetroHarbor HospitalRecruiting

Taichung, 435, Taiwan

National Cheng Kung University HospitalRecruiting

Tainan, 70403, Taiwan

Chi Mei Hospital, LiouyingRecruiting

Tainan, 736402, Taiwan

Mackay Memorial HospitalRecruiting

Taipei, 10449, Taiwan

Cathay General HospitalRecruiting

Taipei, 106, Taiwan

Taipei Medical University HospitalRecruiting

Taipei, 110, Taiwan

Shin Kong Wu Ho-Su Memorial HospitalRecruiting

Taipei, 111045, Taiwan

Taipei Veterans General HospitalRecruiting

Taipei, 112, Taiwan

Taipei Municipal Wanfang HospitalRecruiting

Taipei, 11696, Taiwan

TaoYuan General HospitalRecruiting

Taoyuan City, 330, Taiwan

Chang Gung Memorial Hospital, LinkouRecruiting

Taoyuan City, 333, Taiwan

Antrim Area HospitalRecruiting

Antrim, BT41 2RL, United Kingdom

Basildon HospitalRecruiting

Basildon, SS16 5NL, United Kingdom

Ulster HospitalRecruiting

Belfast, BT16 1RH, United Kingdom

Beltfast City HospitalRecruiting

Belfast, BT9 7AB, United Kingdom

Queen Elizabeth Hospital BirminghamRecruiting

Birmingham, B15 2WB, United Kingdom

Ridgacre House SurgeryRecruiting

Birmingham, B32 2TJ, United Kingdom

Oakenhurst Medical PracticeRecruiting

Blackburn, BB2 1AX, United Kingdom

Royal County Sussex HospitalRecruiting

Brighton, BN2 1ES, United Kingdom

Southmead HospitalRecruiting

Bristol, BS10 5NB, United Kingdom

Pioneer RidingleazeRecruiting

Bristol, BS11 0QE, United Kingdom

Coniston Medical PracticeRecruiting

Bristol, BS34 5TF, United Kingdom

West Suffolk HospitalRecruiting

Bury St Edmunds, IP33 2QZ, United Kingdom

Broomfield HospitalRecruiting

Chelmsford, CM1 7ET, United Kingdom

Hathaway Medical CentreRecruiting

Chippenham, SN14 6GT, United Kingdom

Clevedon Medical CentreRecruiting

Clevedon, BS21 6DG, United Kingdom

Queen Alexandra HospitalRecruiting

Cosham, PO6 3LY, United Kingdom

Daisy Hill HospitalRecruiting

County Down, BT35 8DR, United Kingdom

Boehringer IngelheimContact

unitedkingdom@bitrialsupport.com08000514022

University Hospital CoventryRecruiting

Coventry, CV2 2DX, United Kingdom

Orchard Court SurgeryRecruiting

Darlington, DL3 6HZ, United Kingdom

Darent Valley HospitalRecruiting

Dartford, DA2 8DA, United Kingdom

Dorset County HospitalRecruiting

Dorchester, DT1 2JY, United Kingdom

Russells Hall HospitalRecruiting

Dudley, DY1 2HQ, United Kingdom

University Health CentreRecruiting

Durham, DH1 3JX, United Kingdom

Highland Clinical Research FacilityRecruiting

Fulwood, PR2 9HT, United Kingdom

Woodlands Family PracticeRecruiting

Gillingham, ME7 2BU, United Kingdom

Gloucestershire Royal HospitalRecruiting

Gloucester, GL1 3NN, United Kingdom

James Paget University HospitalRecruiting

Great Yarmouth, NR31 6LA, United Kingdom

The Garth SurgeryRecruiting

Guisborough, TS14 7DJ, United Kingdom

Hereford County HospitalRecruiting

Hereford, HR1 2BN, United Kingdom

Ipswich Hospital (UK)Recruiting

Ipswich, IP4 5PD, United Kingdom

The Queen Elizabeth HospitalRecruiting

Kings Lynn, PE30 4ET, United Kingdom

Pinfold SurgeryRecruiting

Leeds, LS26 9AA, United Kingdom

Ryeland SurgeryRecruiting

Leominster, HR6 8HD, United Kingdom

St Luke's HospitalRecruiting

Little Horton Lane, BD5 0NA, United Kingdom

Boehringer IngelheimContact

unitedkingdom@bitrialsupport.com08000514022

Aintree University HospitalRecruiting

Liverpool, L9 7AL, United Kingdom

North Middlesex University HospitalRecruiting

London, N18 1QX, United Kingdom

Guy's HospitalRecruiting

London, SE1 9RT, United Kingdom

King's College HospitalRecruiting

London, SE5 9RS, United Kingdom

St George's HospitalRecruiting

London, SW17 0QT, United Kingdom

Hammersmith HospitalRecruiting

London, W12 0HS, United Kingdom

Richford Gate Medical PracticeRecruiting

London, W6 7HY, United Kingdom

Altnagelvin Area HospitalRecruiting

Londonderry, BT47 6SB, United Kingdom

Arrowe Park HospitalRecruiting

Metropolitan Borough of Wirral, CH49 5PE, United Kingdom

Linthorpe SurgeryRecruiting

Middlesbrough, TS5 6HA, United Kingdom

Norfolk and Norwich University HospitalRecruiting

Norfolk, NR4 7UY, United Kingdom

Boehringer IngelheimContact

unitedkingdom@bitrialsupport.com08000514022

Northampton General HospitalRecruiting

Northampton, NN1 5BD, United Kingdom

Banbury Cross Health CentreRecruiting

Oxford, OX16 9AD, United Kingdom

Churchill HospitalRecruiting

Oxford, OX3 7LE, United Kingdom

St Bartholomews & Hollow Way Med CentreRecruiting

Oxford, OX4 1XB, United Kingdom

Pickering Medical PracticeRecruiting

Pickering, YO18 8BL, United Kingdom

Lilliput SurgeryRecruiting

Poole, BH14 8EE, United Kingdom

Royal Berkshire HospitalRecruiting

Reading, RG1 5AN, United Kingdom

Alexandra HospitalRecruiting

Redditch, B98 7UB, United Kingdom

Royal Shrewsbury HospitalRecruiting

Shrewsbury, SY3 8XQ, United Kingdom

Lister HospitalRecruiting

Stevenage, SG1 4AB, United Kingdom

Great Western HospitalRecruiting

Swindon, SN3 6BB, United Kingdom

Royal Cornwall HospitalRecruiting

Truro, TR1 3LJ, United Kingdom

Church Street PracticeRecruiting

Wantage, OX12 9BN, United Kingdom

Southend University HospitalRecruiting

Westcliff-on-Sea, SS0 0RY, United Kingdom

168 Parklands Medical CentreRecruiting

Weston-super-Mare, BS24 7PR, United Kingdom

Estuary View Medical CentreRecruiting

Whitstable, CT5 3SE, United Kingdom

Eynsham Medical GroupRecruiting

Witney, OX29 4QB, United Kingdom

Woodthorpe SurgeryRecruiting

York, YO24 2RQ, United Kingdom