Logo 1 Logo 2

Clinical Trial Details

Trial ID: L0171
Source ID: NCT06531824
Associated Drug: Bi 690517
Title: EASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin)
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Kidney Disease, Chronic
Interventions: DRUG: BI 690517|DRUG: Placebo matching BI 690517|DRUG: Empagliflozin
Outcome Measures: Primary: 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, up to 4 years | Secondary: Key secondary outcome: Annual rate of change in eGFR from 3 month visit until last scheduled visit (i.e. chronic eGFR slope), up to 4 years|Time to first event of kidney failure, hospitalization for heart failure or cardiovascular death, up to 4 years|Time to kidney disease progression, up to 4 years|Occurrences of hospitalizations for heart failure (first and any subsequent, combined) or cardiovascular death, up to 4 years|Occurrences of hospitalizations from any cause (first and any subsequent, combined), up to 4 years|Time to first event of kidney disease progression or cardiovascular death, up to 4 years|Time to death from any cause, up to 4 years
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 11000
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-13
Completion Date: 2028-08-30
Results First Posted:
Last Update Posted: 2025-04-23
Locations: Apogee Clinical Research, Huntsville, Alabama, 35805-4104, United States|Southwest Kidney Institute, Surprise, Arizona, 85374-4840, United States|Total Research Group, LLC, Miami, Florida, 33126, United States|Kootenai Research Services, Coeur d'Alene, Idaho, 83814, United States|Lake Michigan Nephrology, Saint Joseph, Michigan, 49085-8511, United States|St. Clair Nephrology Research, LLC, Shelby, Michigan, 48315, United States|Seacoast Kidney and Hypertension Specialists, Portsmouth, New Hampshire, 03801, United States|Brookview Hills Research Associates LLC, Winston-Salem, North Carolina, 27103, United States|Clinical Renal Associates, Upland, Pennsylvania, 19013, United States|Nephrology Associates, Inc, East Providence, Rhode Island, 02914-2641, United States|Texas Institute for Kidney and Endocrine Disorders, Lufkin, Texas, 75904, United States|Renal Specialists of Houston, PA, Pasadena, Texas, 77504-1944, United States|St. Paul's Hospital (Vancouver), Vancouver, British Columbia, V1Y 1S1, Canada|Herlev and Gentofte Hospital, Herlev, 2730, Denmark|Rigshospitalet, København, København, 2100, Denmark|Zealand University Hospita; Roskilde, Roskilde, 4000, Denmark|Nephrologische Gemeinschaftspraxis Bad Nenndorf, Bad Nenndorf, 31542, Germany|Städtisches Klinikum Braunschweig gGmbH, Braunschweig, 38126, Germany|Klinikum Dortmund gGmbH, Dortmund, 44137, Germany|Universitätsklinikum Frankfurt, Frankfurt am Main, 60596, Germany|ClinPhenomics CVC GmbH, Frankfurt, 60596, Germany|Nierenzentrum Freiburg, Freiburg, 79100, Germany|BAG für Nephrologie und Dialyse, Heilbronn, 74076, Germany|Klinikum Konstanz, Konstanz, 78464, Germany|Klinikum der Universität München - Campus Innenstadt, München, 80336, Germany|Dialysezentrum Rotenburg, Rotenburg, 27356, Germany|MVZ Dialysezentrum Schweinfurt, Schweinfurt, 97421, Germany|Robert-Bosch-Krankenhaus GmbH, Stuttgart, 70376, Germany|Nephrologisches Zentrum Villingen-Schwenningen, Villingen-Schwenningen, 78052, Germany|Universitätsklinikum Würzburg AÖR, Würzburg, 97078, Germany|Institute of Post Graduate Medical Education and Research, Chandigarh, 160012, India|Indira Gandhi Institute of Medical Sciences, Patna, 800014, India|All India Institute of Medical Sciences, Raipur, 492099, India|Policlinico S. Orsola-Malpighi, Bologna, 40138, Italy|Firenze-Ospedale San Giovanni di Dio, Firenze, 50124, Italy|Azienda Ospedaliera San Martino, Genova, 16132, Italy|Azienda Ospedaliera Unversitaria di Parma, Parma, 43126, Italy|Fondazione Salvatore Maugeri, Pavia, 27100, Italy|Prato-Ospedale Santo Stefano, Prato, 59100, Italy|Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza, Roma, 00189, Italy|IRCCS Ospedale "Casa Sollievo della Sofferenza", San Giovanni Rotondo (Foggia), 71013, Italy|Azienda Sociosanitaria Ligure 2, Savona, 17100, Italy|Todi-Nuovo Ospedale Media Valle del Tevere, Todi, 06059, Italy|Ospedale Castelli - Verbania, Verbania, 28922, Italy|Hospital Selayang, Batu Caves, 68100, Malaysia|Hospital Sultanah Nora Ismail, Batu Pahat, 83000, Malaysia|Hospital Raja Permaisuri Bainun, Ipoh, 30450, Malaysia|Hospital Sultanah Aminah, Johor Bahru, 80100, Malaysia|Hospital Kajang, Kajang, Selangor, 43000, Malaysia|Hospital Tengku Ampuan Rahimah, Klang, 41200, Malaysia|Hospital Queen Elizabeth, Kota Kinabalu, 88586, Malaysia|Hospital Kuala Lumpur, Kuala Lumpur, 50586, Malaysia|University of Malaya Medical Centre, Kuala Lumpur, 59100, Malaysia|Hospital Tuanku Ampuan Najihah, Kuala Pilah, 72000, Malaysia|Hospital Umum Sarawak, Kuching, 93586, Malaysia|Hospital Melaka, Melaka, 75400, Malaysia|Hospital Pakar Sultanah Fatimah, Muar, 84000, Malaysia|Hospital Sultan Abdul Aziz Shah, Serdang, 43400, Malaysia|Hospital Tuanku Ja'afar, Seremban, 70300, Malaysia|Hospital Sultan Haji Ahmad Shah, Temerloh, 28000, Malaysia|Taipei Medical University-Shuang Ho Hospital, New Taipei City, 23561, Taiwan|Taipei Medical University Hospital, Taipei, 110, Taiwan|Taipei Municipal Wanfang Hospital, Taipei, 11696, Taiwan|Southmead Hospital, Bristol, BS10 5NB, United Kingdom|West Suffolk NHS Foundation Trust, Bury St Edmunds, IP33 2QZ, United Kingdom|Broomfield Hospital, Chelmsford, CM1 7ET, United Kingdom|Clevedon Medical Centre, Clevedon, BS21 6DG, United Kingdom|Dorset County Hospital NHS Foundation Trust, Dorset, DT1 2JY, United Kingdom|Gloucestershire Royal Hospital, Gloucester, GL1 3NN, United Kingdom|Churchill Hospital, Oxford, OX3 7LE, United Kingdom|Pickering Medical Practice, Pickering, YO18 8BL, United Kingdom
URL: https://clinicaltrials.gov/show/NCT06531824

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D313 Ibuprofen small molecule DB01050 Details