A Study to Test Whether Different Doses of BI 690517 Alone or in Combination With Empagliflozin Improve Kidney Function in People With Chronic Kidney Disease
Launched by BOEHRINGER INGELHEIM · Jan 5, 2022
Trial Information
Current as of May 17, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- • Inclusion criteria
- • Signed and dated written informed consent in accordance with International Council on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
- • Male or female patients of legal adult age (according to local legislation) and aged ≥ 18 years at time of consent.
- • estimated Glomerular Filtration Rate (eGFR, Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula) ≥ 30 and \< 90 mL/min/1.73 m2 at Visit 1 by central laboratory analysis.
- • Urine Albumin Creatinine Ratio (UACR) ≥ 200 and \< 5,000 mg/g in spot urine (midstream urine sample) by central laboratory analysis at Visit 1.1
- • If the patient is taking any of the following medications they should be on a stable dose for at least 4 weeks prior to visit 1 and until first randomisation prior to run-in with no planned change of the therapy during the trial: anti-hypertensives, Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), endothelin receptor antagonists, low dose systemic steroids (e.g. prednisolone ≤10 mg or equivalent).
- • Treatment with a clinically appropriate, stable dose of either Angiotensin-Converting Enzyme Inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB) (but not both together), for ≥ 4 weeks prior to visit 1 and until first randomisation with no planned change of the therapy during the trial.
- • In the Investigator's opinion, any kind of diagnosed chronic kidney disease (Diagnosis can be reached by standard clinical method, no biopsy required). Patients with diabetic kidney disease must have type 2 diabetes mellitus and their treatment (including GLP1 receptor agonist) should be unchanged or changes deemed minor (according to investigator's judgement) within 4 weeks prior to Visit 1 and until first randomisation.
- • Glycated Haemoglobin (HbA1c) \< 10.0% at Visit 1 measured by the central laboratory.
- • Serum potassium ≤ 4.8 mmol/L at Visit 1 measured by the central laboratory.
- • Seated Systolic Blood Pressure (SBP) ≥ 110 and ≤ 160 mmHg and Diastolic Blood Pressure (DBP) ≥ 65 and ≤ 110 mmHg at Visit 1 (mean values from three Blood Pressure (BP) measurements) and optimised anti-hypertensive treatment according to local standard of care and investigator's judgement.
- • Body Mass Index (BMI) ≥ 18.5 and \< 50 kg/m2 at Visit 1.
- • Women of child-bearing potential2 (WOCBP) must be ready and able to use highly effective methods of birth control. Such methods should be used throughout the trial. Men must be vasectomised or willing and able to use a condom if their partner is a WOCBP.
- Additional inclusion criteria to be assessed before second randomisation (start of Treatment Period):
- • Serum potassium ≤ 4.8 mmol/L measured by local or central laboratory within 7 days prior to randomisation to the Treatment Period.
- • eGFR (Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula) ≥ 20 mL/min/1.73 m2 measured by local or central laboratory within 7 days prior to randomisation to the Treatment Period.
- • Exclusion criteria
- • Treatment with inhibitors of aldosterone mediated effects (e.g., mineralocorticoid receptor antagonists such as spironolactone), or intake of other potassium sparing diuretics (e.g., amiloride) within 7 days prior to first randomisation or planned during trial treatment phase.
- • Treatment with other Renin Angiotensin Aldosterone System (RAAS) interventions (apart from either Angiotensin-Converting Enzyme Inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB)) within 4 weeks prior to Visit 1 and throughout screening or planned during the trial. Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial are also excluded.
- • Type 1 diabetes mellitus, or history of other autoimmune causes of diabetes mellitus (e.g. Latent Autoimmune Diabetes (LADA))
- • Patients at increased risk of ketoacidosis in the opinion of the investigator.
- • Currently receiving Sodium-glucose cotransporter (SGLT)-2 or SGLT-1/2 inhibitor or planned initiation during the trial.
- • Further criteria apply.
About Boehringer Ingelheim
Boehringer Ingelheim is a global, research-driven pharmaceutical company dedicated to improving health and quality of life through innovative therapies. Established in 1885 and headquartered in Ingelheim, Germany, the company focuses on the development of prescription medicines in key therapeutic areas, including respiratory diseases, cardiovascular health, oncology, and immunology. Boehringer Ingelheim is committed to advancing medical science through rigorous clinical trials and collaborative research, striving to bring novel treatments to patients while upholding the highest standards of safety and efficacy. With a strong emphasis on sustainability and corporate responsibility, the company aims to make a meaningful impact on global health challenges.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Tampere, , Finland
Liverpool, New South Wales, Australia
Hong Kong, , Hong Kong
Beaver, Pennsylvania, United States
Cleveland, Ohio, United States
Vila Nova De Gaia, , Portugal
Barcelona, , Spain
Hannover, , Germany
Toronto, Ontario, Canada
Madrid, , Spain
New Lambton Heights, New South Wales, Australia
Córdoba, , Spain
Dresden, , Germany
Spokane, Washington, United States
Leuven, , Belgium
Seoul, , Korea, Republic Of
Chicago, Illinois, United States
Almada, , Portugal
New Delhi, , India
Fitzroy, Victoria, Australia
Dallas, Texas, United States
Ankara, , Turkey
Lausanne, , Switzerland
Riverside, California, United States
Vellore, , India
Seoul, , Korea, Republic Of
Houston, Texas, United States
Wichita, Kansas, United States
Bruxelles, , Belgium
Aarhus N, , Denmark
Davao City, , Philippines
Sofia, , Bulgaria
Seoul, , Korea, Republic Of
Budapest, , Hungary
Seoul, , Korea, Republic Of
Guangzhou, , China
San Dimas, California, United States
Kansas City, Missouri, United States
Nadiad, , India
Bonheiden, , Belgium
Stara Zagora, , Bulgaria
Baja, , Hungary
Ansan, , Korea, Republic Of
Krugersdorp, , South Africa
Bloemfontein, , South Africa
Leipzig, , Germany
Shanghai, , China
Kuopio, , Finland
Linköping, , Sweden
Guangzhou, , China
Hong Kong, , Hong Kong
Nagano, Suwa, , Japan
Seoul, , Korea, Republic Of
Lauderdale Lakes, Florida, United States
Marikina City, , Philippines
Pasig City, , Philippines
Majadahonda, , Spain
Albuquerque, New Mexico, United States
Northridge, California, United States
Brussel, , Belgium
Hillerød, , Denmark
Palma De Mallorca, , Spain
Knoxville, Tennessee, United States
Debrecen, , Hungary
Nuevo León, , Mexico
Flint, Michigan, United States
Sao Paulo, , Brazil
Red Deer, Alberta, Canada
Liberec, , Czechia
Slany, , Czechia
Balatonfured, , Hungary
Eger, , Hungary
Seri Manjung, , Malaysia
Lublin, , Poland
Cape Town, , South Africa
Cape Town, , South Africa
Durban, , South Africa
Krugersdorp, , South Africa
Iloilo City, , Philippines
Tacoma, Washington, United States
Frankfurt, , Germany
Montreal, Quebec, Canada
Etobicoke, Ontario, Canada
Bad Oeynhausen, , Germany
Bergamo, , Italy
Shiga, Omihachiman, , Japan
Leiria, , Portugal
Phoenix, Arizona, United States
Nagano, Ina, , Japan
Saitama, Kawagoe, , Japan
México, , Mexico
Cape Town, , South Africa
Tokyo, Hachioji, , Japan
Waterloo, Ontario, Canada
La Louvière, , Belgium
Aichi, Nagoya, , Japan
Tokyo, Shinagawa Ku, , Japan
Würzburg, , Germany
Poznan, , Poland
Lisboa, , Portugal
Brandon, Florida, United States
Athens, , Greece
Lodelinsart, , Belgium
Seoul, , Korea, Republic Of
Gdansk, , Poland
Gdynia, , Poland
Katowice, , Poland
Warszawa, , Poland
Wroclaw, , Poland
Aguascalientes, , Mexico
Rajkot, , India
Sofia, , Bulgaria
Batu Caves, , Malaysia
Ciudad Autonoma Buenos Aires, , Argentina
Mar Del Plata, , Argentina
Villa Luro, , Argentina
São Bernardo Do Campo, , Brazil
México, , Mexico
Morehead City, North Carolina, United States
København ø, , Denmark
Miami, Florida, United States
P. Faliro, , Greece
Cebu City, , Philippines
Hangzhou, , China
Stockholm, , Sweden
Istanbul, , Turkey
Canyon Country, California, United States
Dresden, , Germany
Bydgoszcz, , Poland
Asheboro, North Carolina, United States
Coral Gables, Florida, United States
Northridge, California, United States
Miami, Florida, United States
Portsmouth, New Hampshire, United States
El Paso, Texas, United States
Lufkin, Texas, United States
Brampton, Ontario, Canada
Shanghai, , China
Bari, , Italy
Tokyo, Bunkyo Ku, , Japan
Cheras, Kuala Lumpur, , Malaysia
Cape Town, , South Africa
Rapid City, South Dakota, United States
Plovdiv, , Bulgaria
Ocoee, Florida, United States
Prague, , Czechia
Box Hill, Victoria, Australia
Denver, Colorado, United States
Las Vegas, Nevada, United States
Shanghai, Shanghai, China
Cheongiu, , Korea, Republic Of
Aichi, Nagoya, , Japan
Bloemfontein, , South Africa
Temple Terrace, Florida, United States
Santa Catarina, , Brazil
Nampa, Idaho, United States
Caba, , Argentina
Cordoba, , Argentina
Rosario, , Argentina
Aveiro, , Portugal
Carnaxide, , Portugal
Herlev, , Denmark
Budapest, , Hungary
Gyula, , Hungary
Czestochowa, , Poland
Poznan, , Poland
Pembroke Pines, Florida, United States
Lublin, , Poland
Botucatu, , Brazil
Sao Paulo, , Brazil
Rio De Janeiro, , Brazil
Sugar Land, Texas, United States
Düsseldorf, , Germany
Nanning, , China
Goyang, , Korea, Republic Of
Mesa, Arizona, United States
Long Beach, California, United States
Fort Lauderdale, Florida, United States
Miami, Florida, United States
Flint, Michigan, United States
Canton, Ohio, United States
Upland, Pennsylvania, United States
Buenos Aires, , Argentina
Junín, , Argentina
Liège, , Belgium
Belém, , Brazil
Curitiba, , Brazil
Porto Alegre, , Brazil
Ruse, , Bulgaria
Sofia, , Bulgaria
Burlington, Ontario, Canada
Turku, , Finland
Berlin, , Germany
Thessaloniki, , Greece
Hatvan, , Hungary
Jaipur, , India
Kanpur, , India
Mysore, , India
Nagpur, , India
Surat, , India
Varanasi, , India
Aichi, Ichinomiya, , Japan
Gumma, Takasaki, , Japan
Kyoto, Kuse Gun, , Japan
Ueda, Nagano, , Japan
Kota Bharu, , Malaysia
Mexico, , Mexico
Stavanger, , Norway
Lodz, , Poland
Lodz, , Poland
Pretoria, , South Africa
Burela, , Spain
Kristianstad, , Sweden
Stockholm, , Sweden
Havirov, , Czechia
Kangar, , Malaysia
Katowice, , Poland
Poznan, , Poland
São Paulo, , Brazil
Prague, , Czechia
Pribram, , Czechia
Athens, , Greece
Guadalajara, , Mexico
Mexico, , Mexico
Nordbyhagen, , Norway
Quezon City, , Philippines
Tarlac, , Philippines
Waterloo, Ontario, Canada
Ioannina, , Greece
Larissa, , Greece
Aurangabad, , India
Jaipur, , India
Lodz, , Poland
Olsztyn, , Poland
Pomorskie, , Poland
Warszawa, , Poland
Johor Bahru, , Malaysia
Mar Del Plata, , Argentina
Porto Alegre, , Brazil
Aichi, Nagoya, , Japan
Balatonfured, , Hungary
Riverside, California, United States
Warszawa, , Poland
Lodz, , Poland
Poznan, , Poland
Wroclaw, , Poland
Warszawa, , Poland
Asheboro, North Carolina, United States
Leiria, , Portugal
Vila Nova De Gaia, , Portugal
Aveiro, , Portugal
Sao Paulo, , Brazil
Leuven/Vlaams Brabant, , Belgium
Poznan, , Poland
Almada, , Portugal
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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