EASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin)
- Conditions
- Kidney Disease, Chronic
- Interventions
- Registration Number
- NCT06531824
- Lead Sponsor
- Boehringer Ingelheim
- 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 disease.
This study has 2 parts. In the first part, participants get empagliflozin or placebo matching BI 690517 for at least 6 weeks. Participants continue taking ACEi or ARB throughout the study if such treatments are indicated. In the second part, participants are divided into 2 groups by chance. One group takes BI 690517 tablets and the other group takes placebo tablets. Placebo tablets look like BI 690517 tablets but do not contain any medicine. Participants take 1 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 4 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 11000
-
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; or
- CKD-EPI eGFR ≥45 <90 mL/min/1.73m² with urine albumin-to-creatinine ratio (uACR) ≥200 mg/g (or protein-to-creatinine ratio ≥300 mg/g).
-
Neither requires an Aldosterone Synthase inhibitor (ASi) or Mineralocorticoid Receptor Antagonist (MRA), nor that such treatment is definitely inappropriate.
Key
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1: Run-in period (all participants) Placebo matching BI 690517 Eligible participants will enter a Run-in period during which they will receive placebo matching BI 690517 + empagliflozin. Part 1: Run-in period (all participants) Empagliflozin Eligible participants will enter a Run-in period during which they will receive placebo matching BI 690517 + empagliflozin. Part 2: Randomized treatment, follow-up period, treatment group BI 690517 - Part 2: Randomized treatment, follow-up period, treatment group Empagliflozin - Part 2: Follow-up period, placebo group Placebo matching BI 690517 - Part 2: Follow-up period, placebo group Empagliflozin -
- Primary Outcome Measures
Name Time Method Time to first occurrence of the primary composite outcome of: (i) Kidney disease progression*; or (ii) Hospitalization for heart failure; or (iii) Cardiovascular death. up to 4 years Kidney disease progression is defined as kidney failure or a sustained decline of ≥40% in estimated Glomerular Filtration Rate (eGFR) from randomization
- Secondary Outcome Measures
Name Time Method Time to first event of kidney disease progression or cardiovascular death up to 4 years Time to first event of kidney failure, hospitalization for heart failure or cardiovascular death 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 death from any cause up to 4 years 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 kidney disease progression up to 4 years
Trial Locations
- Locations (104)
Apogee Clinical Research
🇺🇸Huntsville, Alabama, United States
Herz- und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen
🇩🇪Bad Oeynhausen, Germany
Southwest Kidney Institute
🇺🇸Surprise, Arizona, United States
Total Research Group, LLC
🇺🇸Miami, Florida, United States
Kootenai Research Services
🇺🇸Coeur d'Alene, Idaho, United States
Lake Michigan Nephrology
🇺🇸Saint Joseph, Michigan, United States
St. Clair Nephrology Research, LLC
🇺🇸Shelby, Michigan, United States
Seacoast Kidney and Hypertension Specialists
🇺🇸Portsmouth, New Hampshire, United States
Brookview Hills Research Associates LLC
🇺🇸Winston-Salem, North Carolina, United States
Clinical Renal Associates
🇺🇸Upland, Pennsylvania, United States
Nephrology Associates, Inc
🇺🇸East Providence, Rhode Island, United States
Texas Institute for Kidney and Endocrine Disorders
🇺🇸Lufkin, Texas, United States
Renal Specialists of Houston, PA
🇺🇸Pasadena, Texas, United States
St. Paul's Hospital (Vancouver)
🇨🇦Vancouver, British Columbia, Canada
Herlev and Gentofte Hospital
🇩🇰Herlev, Denmark
Rigshospitalet, København
🇩🇰København, Denmark
Zealand University Hospita; Roskilde
🇩🇰Roskilde, Denmark
Universitätsklinikum Aachen, AöR
🇩🇪Aachen, Germany
Nephrologische Gemeinschaftspraxis Bad Nenndorf
🇩🇪Bad Nenndorf, Germany
Praxis für Nierenkrankheiten und Dialyse Helle Mitte
🇩🇪Berlin, Germany
Universitätsklinikum Bonn AöR
🇩🇪Bonn, Germany
Städtisches Klinikum Braunschweig gGmbH
🇩🇪Braunschweig, Germany
Klinikum Dortmund gGmbH
🇩🇪Dortmund, Germany
Dialysezentrum Elsenfeld
🇩🇪Elsenfeld, Germany
Agaplesion Markus Krankenhaus
🇩🇪Frankfurt am Main, Germany
Universitätsklinikum Frankfurt
🇩🇪Frankfurt am Main, Germany
ClinPhenomics CVC GmbH
🇩🇪Frankfurt, Germany
Nierenzentrum Freiburg
🇩🇪Freiburg, Germany
Universitätsklinikum Gießen und Marburg GmbH
🇩🇪Gießen, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Zentrum Für Nieren Hochdruck und Stoffwechselerkrankungen
🇩🇪Hannover, Germany
BAG für Nephrologie und Dialyse
🇩🇪Heilbronn, Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel
🇩🇪Kiel, Germany
Klinikum Konstanz
🇩🇪Konstanz, Germany
Universitätsklinikum Magdeburg AöR
🇩🇪Magdeburg, Germany
Klinikum der Universität München - Campus Innenstadt
🇩🇪München, Germany
Dialysezentrum Neckarsulm
🇩🇪Neckarsulm, Germany
Dialysezentrum Rotenburg
🇩🇪Rotenburg, Germany
MVZ Dialysezentrum Schweinfurt
🇩🇪Schweinfurt, Germany
Robert-Bosch-Krankenhaus GmbH
🇩🇪Stuttgart, Germany
Nephrologisches Zentrum Villingen-Schwenningen
🇩🇪Villingen-Schwenningen, Germany
Nierenzentrum Wiesbaden
🇩🇪Wiesbaden, Germany
Universitätsklinikum Würzburg AÖR
🇩🇪Würzburg, Germany
St John's Medical College
🇮🇳Bangalore, India
Institute of Post Graduate Medical Education and Research
🇮🇳Chandigarh, India
Osmania Medical College & Hospital
🇮🇳Hyderabad, India
Max Super Specialty Hospital, Saket
🇮🇳New Delhi, India
Indira Gandhi Institute of Medical Sciences
🇮🇳Patna, India
All India Institute of Medical Sciences
🇮🇳Raipur, India
Ospedale Civile Ss. Antonio e Biagio
🇮🇹Alessandria, Italy
Asti-Ospedale Cardinal Massaia
🇮🇹Asti, Italy
ASST Papa Giovanni XXIII
🇮🇹Bergamo, Italy
Policlinico S. Orsola-Malpighi
🇮🇹Bologna, Italy
A.S.O.S. Croce e Carle
🇮🇹Cuneo, Italy
Firenze-Ospedale San Giovanni di Dio
🇮🇹Firenze, Italy
Azienda Ospedaliera Careggi
🇮🇹Firenze, Italy
Azienda Ospedaliera San Martino
🇮🇹Genova, Italy
Asst Santi Paolo E Carlo
🇮🇹Milano, Italy
Ospedale Maggiore della Carità
🇮🇹Novara, Italy
Azienda Ospedaliera Unversitaria di Parma
🇮🇹Parma, Italy
Fondazione Salvatore Maugeri
🇮🇹Pavia, Italy
Azienda Ospedaliera Universitaria Pisana
🇮🇹Pisa, Italy
Prato-Ospedale Santo Stefano
🇮🇹Prato, Italy
Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
🇮🇹Roma, Italy
IRCCS Ospedale "Casa Sollievo della Sofferenza"
🇮🇹San Giovanni Rotondo (Foggia), Italy
Azienda Sociosanitaria Ligure 2
🇮🇹Savona, Italy
Todi-Nuovo Ospedale Media Valle del Tevere
🇮🇹Todi, Italy
Ospedale Castelli - Verbania
🇮🇹Verbania, Italy
Hospital Selayang
🇲🇾Batu Caves, Malaysia
Hospital Sultanah Nora Ismail
🇲🇾Batu Pahat, Malaysia
Hospital Pulau Pinang-Pulau Pinang-21953
🇲🇾Georgetown, Malaysia
Hospital Raja Permaisuri Bainun
🇲🇾Ipoh, Malaysia
Hospital Sultanah Aminah
🇲🇾Johor Bahru, Malaysia
Hospital Kajang
🇲🇾Kajang, Selangor, Malaysia
Hospital Tengku Ampuan Rahimah
🇲🇾Klang, Malaysia
Hospital Queen Elizabeth
🇲🇾Kota Kinabalu, Malaysia
Hospital Kuala Lumpur
🇲🇾Kuala Lumpur, Malaysia
University of Malaya Medical Centre
🇲🇾Kuala Lumpur, Malaysia
Hospital Tuanku Ampuan Najihah
🇲🇾Kuala Pilah, Malaysia
Hospital Tengku Ampuan Afzan
🇲🇾Kuantan, Malaysia
Hospital Umum Sarawak
🇲🇾Kuching, Malaysia
Hospital Kulim
🇲🇾Kulim, Malaysia
Hospital Melaka
🇲🇾Melaka, Malaysia
Hospital Pakar Sultanah Fatimah
🇲🇾Muar, Malaysia
Hospital Seberang Jaya
🇲🇾Perai, Malaysia
Hospital Sultan Abdul Aziz Shah
🇲🇾Serdang, Malaysia
Hospital Tuanku Ja'afar
🇲🇾Seremban, Malaysia
Hospital Taiping
🇲🇾Taiping, Malaysia
Hospital Teluk Intan
🇲🇾Teluk Intan, Malaysia
Hospital Sultan Haji Ahmad Shah
🇲🇾Temerloh, Malaysia
Taipei Medical University-Shuang Ho Hospital
🇨🇳New Taipei City, Taiwan
Taipei Medical University Hospital
🇨🇳Taipei, Taiwan
Taipei Municipal Wanfang Hospital
🇨🇳Taipei, Taiwan
South Eastern Health & Social Care Trust
🇬🇧Belfast, United Kingdom
University Hospitals Sussex NHS Foundation Trusts
🇬🇧Brighton, United Kingdom
Southmead Hospital
🇬🇧Bristol, United Kingdom
West Suffolk NHS Foundation Trust
🇬🇧Bury St Edmunds, United Kingdom
Broomfield Hospital
🇬🇧Chelmsford, United Kingdom
Clevedon Medical Centre
🇬🇧Clevedon, United Kingdom
Dorset County Hospital NHS Foundation Trust
🇬🇧Dorset, United Kingdom
Gloucestershire Royal Hospital
🇬🇧Gloucester, United Kingdom
Imperial College Healthcare NHS Trust
🇬🇧London, United Kingdom
Churchill Hospital
🇬🇧Oxford, United Kingdom
Pickering Medical Practice
🇬🇧Pickering, United Kingdom