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

Status: Recruiting
Location: See all (200) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
Apogee Clinical Research
RECRUITING
Huntsville
Arizona
Southwest Kidney Institute
RECRUITING
Surprise
Florida
Florida Kidney Physicians LLC
NOT_YET_RECRUITING
Jacksonville Beach
Total Research Group, LLC
RECRUITING
Miami
Georgia
East Coast Institute For Research LLC
RECRUITING
Macon
Idaho
Kootenai Research Services
RECRUITING
Coeur D'alene
Kansas
Kansas Nephrology Research Institute, LLC
RECRUITING
Wichita
Michigan
Lake Michigan Nephrology
RECRUITING
Saint Joseph
St. Clair Nephrology Research, LLC
RECRUITING
Shelby
North Carolina
Metrolina Nephrology Associates, PA
RECRUITING
Charlotte
Brookview Hills Research Associates LLC
RECRUITING
Winston-salem
Nebraska
Great Plains Nephrology
RECRUITING
North Platte
New Hampshire
Seacoast Kidney and Hypertension Specialists
RECRUITING
Portsmouth
Pennsylvania
Northeast Endocrine Metabolic Associates
RECRUITING
Philadelphia
Clinical Renal Associates
RECRUITING
Upland
Rhode Island
Nephrology Associates, Inc
RECRUITING
East Providence
Texas
Dallas Nephrology Associates Medical Clinic
NOT_YET_RECRUITING
Desoto
Texas Institute for Kidney and Endocrine Disorders
RECRUITING
Lufkin
Renal Specialists of Houston, PA
RECRUITING
Pasadena
Virginia
University of Virginia Health System
RECRUITING
Charlottesville
Tidewater Physicians Multispecialty Group
RECRUITING
Newport News
Washington
Providence Medical Research Center
RECRUITING
Spokane
Other Locations
Brazil
Fundação Oswaldo Ramos (Hospital do Rim)
NOT_YET_RECRUITING
São Paulo
Canada
Centricity Research (Brampton)
NOT_YET_RECRUITING
Brampton
Centricity Research (Vaughan)
NOT_YET_RECRUITING
Concord
University of Alberta Hospital (University of Alberta)
RECRUITING
Edmonton
Royal Inland Hospital
RECRUITING
Kamloops
Kelowna General Hospital
RECRUITING
Kelowna
Queen's University
NOT_YET_RECRUITING
Kingston
London Regional Cancer Program - London Health Sciences Ctr.
RECRUITING
London
Centre hospitalier de l'Université de Montréal (CHUM)
NOT_YET_RECRUITING
Montreal
Lakeridge Health Oshawa
NOT_YET_RECRUITING
Oshawa
Northern Health
NOT_YET_RECRUITING
Prince George
CHU de Quebec-Universite Laval Research Centre
NOT_YET_RECRUITING
Québec
CIUSSS Nord de l'île de Montreal
RECRUITING
Québec
CIUSSS de l Estrie-CHUS
NOT_YET_RECRUITING
Sherbrooke
Fraser Health
RECRUITING
Surrey
St. Michael's Hospital
RECRUITING
Toronto
Sunnybrook Health Sciences Centre
RECRUITING
Toronto
Toronto General Hospital
RECRUITING
Toronto
St. Paul's Hospital (Vancouver)
NOT_YET_RECRUITING
Vancouver
China
Fuwai Hospital, CAMS&PUMC
NOT_YET_RECRUITING
Beijing
The Second Hospital of Chaoyang
NOT_YET_RECRUITING
Chaoyang
Guangdong Provincial Hospital of Chinese Medicine
NOT_YET_RECRUITING
Guangzhou
Guangzhou Red Cross Hospital
NOT_YET_RECRUITING
Guangzhou
Taizhou Hospital of Zhejiang Province
NOT_YET_RECRUITING
Taizhou
Zhuzhou Central Hospital
NOT_YET_RECRUITING
Zhuzhou
Denmark
Rigshospitalet, København
RECRUITING
Copenhagen
Herlev and Gentofte Hospital
RECRUITING
Herlev
Kolding Hospital
NOT_YET_RECRUITING
Kolding
Odense University Hospital
NOT_YET_RECRUITING
Odense
Zealand University Hospita; Roskilde
RECRUITING
Roskilde
Germany
Universitätsklinikum Aachen, AöR
RECRUITING
Aachen
Nephrologische Gemeinschaftspraxis Bad Nenndorf
RECRUITING
Bad Nenndorf
Herz- und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen
RECRUITING
Bad Oeynhausen
Praxis für Nierenkrankheiten und Dialyse Helle Mitte
RECRUITING
Berlin
Universitätsklinikum Bonn AöR
RECRUITING
Bonn
Städtisches Klinikum Braunschweig gGmbH
RECRUITING
Braunschweig
Klinikum Dortmund gGmbH
RECRUITING
Dortmund
Universitätsklinikum Düsseldorf
RECRUITING
Düsseldorf
Dialysezentrum Elsenfeld
RECRUITING
Elsenfeld
ClinPhenomics CVC GmbH
RECRUITING
Frankfurt
Agaplesion Markus Krankenhaus
RECRUITING
Frankfurt Am Main
Universitätsklinikum Frankfurt
RECRUITING
Frankfurt Am Main
Nierenzentrum Freiburg
RECRUITING
Freiburg Im Breisgau
Universitätsklinikum Gießen und Marburg GmbH
RECRUITING
Giessen
Universitätsklinikum Hamburg, Eppendorf
RECRUITING
Hamburg
Medizinische Hochschule Hannover
RECRUITING
Hanover
Zentrum Für Nieren Hochdruck und Stoffwechselerkrankungen
RECRUITING
Hanover
BAG für Nephrologie und Dialyse
RECRUITING
Heilbronn
Ruhr-Universität Bochum
RECRUITING
Herne
Universität des Saarlandes
RECRUITING
Homburg
Universitätsklinikum Schleswig-Holstein, Campus Kiel
RECRUITING
Kiel
Klinikum Konstanz
RECRUITING
Konstanz
Dr. Vehling-Kaiser MVZ GmbH
NOT_YET_RECRUITING
Landshut
KfH Nierenzentrum Leipzig
RECRUITING
Leipzig
Universitätsklinikum Magdeburg AöR
RECRUITING
Magdeburg
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
RECRUITING
Mainz
Klinikum der Universität München - Campus Innenstadt
RECRUITING
München
Dialysezentrum Neckarsulm
RECRUITING
Neckarsulm
Universitätsmedizin Rostock
NOT_YET_RECRUITING
Rostock
Dialysezentrum Rotenburg
RECRUITING
Rotenburg (wümme)
MVZ Dialysezentrum Schweinfurt
RECRUITING
Schweinfurt
Robert-Bosch-Krankenhaus GmbH
RECRUITING
Stuttgart
KfH-Nierenzentrum Traunstein
RECRUITING
Traunstein
Nephrologisches Zentrum Villingen-Schwenningen
RECRUITING
Villingen-schwenningen
Nierenzentrum Wiesbaden
RECRUITING
Wiesbaden
Helios Universitätsklinikum Wuppertal
RECRUITING
Wuppertal
Universitätsklinikum Würzburg AÖR
RECRUITING
Würzburg
India
Manipal Hospital
RECRUITING
Bangalore
St John's Medical College
RECRUITING
Bangalore
Institute of Post Graduate Medical Education and Research
RECRUITING
Chandigarh
Karnataka Medical college and research institute
RECRUITING
Hubballi
Osmania Medical College & Hospital
RECRUITING
Hyderabad
Nil Ratan Sircar Medical College & Hospital
RECRUITING
Kolkata
IQRAA International hospital & research centre.
RECRUITING
Kozhikode
Dr Ram Manohar Lohia Institute of Medical Sciences
RECRUITING
Lucknow
Muljibhai Patel Urological Hospital
RECRUITING
Nadiād
All India Institute of Medical Sciences
NOT_YET_RECRUITING
New Delhi
Epitome Kidney Urology Institute and Lions Hospital
RECRUITING
New Delhi
Max Super Specialty Hospital, Saket
RECRUITING
New Delhi
Indira Gandhi Institute of Medical Sciences
RECRUITING
Patna
Jawaharlal Institute of Postgraduate Medical Education
RECRUITING
Puducherry
All India Institute of Medical Sciences
RECRUITING
Raipur
Yashoda Hospitals - Secunderabad
RECRUITING
Secunderabad
Kimshealth
NOT_YET_RECRUITING
Trivandrum
Christian Medical College
RECRUITING
Vellore
Italy
Ospedale Civile Ss. Antonio e Biagio
RECRUITING
Alessandria
Asti-Ospedale Cardinal Massaia
RECRUITING
Asti
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
RECRUITING
Bari
ASST Papa Giovanni XXIII
RECRUITING
Bergamo
Policlinico S. Orsola-Malpighi
RECRUITING
Bologna
Azienda Ospedaliera ARNAS G. Brotzu
RECRUITING
Cagliari
Chieri-Ospedale Maggiore
RECRUITING
Chieri
A.S.O.S. Croce e Carle
RECRUITING
Cuneo
Azienda Ospedaliera Careggi
RECRUITING
Florence
Firenze-Ospedale San Giovanni di Dio
RECRUITING
Florence
Azienda Ospedaliera San Martino
RECRUITING
Genova
Asst Santi Paolo E Carlo
RECRUITING
Milan
Fondazione IRCCS San Gerardo dei Tintori
NOT_YET_RECRUITING
Monza
Ospedale Maggiore della Carità
NOT_YET_RECRUITING
Novara
Azienda Ospedaliera Unversitaria di Parma
RECRUITING
Parma
Fondazione Salvatore Maugeri
RECRUITING
Pavia
Azienda Ospedaliera Universitaria Pisana
NOT_YET_RECRUITING
Pisa
Prato-Ospedale Santo Stefano
RECRUITING
Prato
Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
RECRUITING
Roma
IRCCS Ospedale Casa Sollievo della Sofferenza
RECRUITING
San Giovanni Rotondo (foggia)
Azienda Sociosanitaria Ligure 2
RECRUITING
Savona
Todi-Nuovo Ospedale Media Valle del Tevere
RECRUITING
Todi
Torino-Ospedale Oftalmico
RECRUITING
Turin
Ospedale Castelli - Verbania
RECRUITING
Verbania
Ospedale San Bortolo
RECRUITING
Vicenza
Malaysia
Hospital Ampang
NOT_YET_RECRUITING
Ampang
Hospital Selayang
RECRUITING
Batu Caves
Hospital Sultanah Nora Ismail
RECRUITING
Batu Pahat
Hospital Pulau Pinang-Pulau Pinang-21953
RECRUITING
George Town
Hospital Raja Permaisuri Bainun
RECRUITING
Ipoh
Hospital Sultanah Aminah
RECRUITING
Johor Bahru
Hospital Kajang
RECRUITING
Kajang, Selangor
Hospital Tengku Ampuan Rahimah
RECRUITING
Klang
Hospital Queen Elizabeth
RECRUITING
Kota Kinabalu
Hospital Kuala Lumpur
RECRUITING
Kuala Lumpur
University of Malaya Medical Centre
RECRUITING
Kuala Lumpur
Hospital Tuanku Ampuan Najihah
RECRUITING
Kuala Pilah
Hospital Tengku Ampuan Afzan
RECRUITING
Kuantan
Hospital Umum Sarawak
RECRUITING
Kuching
Hospital Kulim
RECRUITING
Kulim
Hospital Melaka
NOT_YET_RECRUITING
Malacca
Hospital Pakar Sultanah Fatimah
RECRUITING
Muar Town
Hospital Seberang Jaya
RECRUITING
Perai
Hospital Sultan Abdul Aziz Shah
RECRUITING
Serdang
Hospital Tuanku Ja'afar
RECRUITING
Seremban
Hospital Taiping
RECRUITING
Taiping
Hospital Teluk Intan
NOT_YET_RECRUITING
Teluk Intan
Hospital Sultan Haji Ahmad Shah
RECRUITING
Temerluh
Portugal
ULS da Região de Aveiro
RECRUITING
Aveiro
Unidade Local de Saúde do Algarve, E.P.E
RECRUITING
Faro
SESARAM
NOT_YET_RECRUITING
Funchal
ULS de São João
RECRUITING
Porto
Unidade Local de Saúde de Matosinhos
RECRUITING
Senhora Da Hora
Unidade Local De Saude Da Arrabida E.P.E.
NOT_YET_RECRUITING
Setúbal
Taiwan
E-Da Hospital
NOT_YET_RECRUITING
Kaohsiung City
Lotung Poh-Ai Hospital
RECRUITING
Luodong Township
Fu Jen Catholic University Hospital
RECRUITING
New Taipei City
Taipei Medical University-Shuang Ho Hospital
RECRUITING
New Taipei City
Tungs' Taichung MetroHarbor Hospital
NOT_YET_RECRUITING
Taichung
Chi Mei Hospital, Liouying
NOT_YET_RECRUITING
Tainan City
National Cheng Kung University Hospital
RECRUITING
Tainan City
Cathay General Hospital
NOT_YET_RECRUITING
Taipei
Taipei Medical University Hospital
RECRUITING
Taipei
Taipei Municipal Wanfang Hospital
RECRUITING
Taipei
United Kingdom
Belfast Health and Social Care Trust
RECRUITING
Belfast
South Eastern Health & Social Care Trust
RECRUITING
Belfast
Oakenhurst Medical Practice
RECRUITING
Blackburn
University Hospitals Sussex NHS Foundation Trusts
RECRUITING
Brighton
Southmead Hospital
RECRUITING
Bristol
West Suffolk NHS Foundation Trust
RECRUITING
Bury St Edmunds
Broomfield Hospital
RECRUITING
Chelmsford
Hathaway Medical Centre
RECRUITING
Chippenham
Clevedon Medical Centre
RECRUITING
Clevedon
Queen Alexandra Hospital
RECRUITING
Cosham
Daisy Hill Hospital
RECRUITING
County Down
University Hospitals Coventry and Warwickshire NHS Trust
NOT_YET_RECRUITING
Coventry
Dorset County Hospital NHS Foundation Trust
RECRUITING
Dorset
Highland Clinical Research Facility
RECRUITING
Fulwood
Gloucestershire Royal Hospital
NOT_YET_RECRUITING
Gloucester
Hereford County Hospital
RECRUITING
Hereford
Aintree University Hospital
RECRUITING
Liverpool
Imperial College Healthcare NHS Trust
RECRUITING
London
St George's University Hospitals NHS Foundation Trust
RECRUITING
London
Altnagelvin Area Hospital
RECRUITING
Londonderry
Norfolk and Norwich University Hospital
RECRUITING
Norfolk
Nottingham University Hospitals NHS Trust
RECRUITING
Nottingham
Churchill Hospital
RECRUITING
Oxford
Pickering Medical Practice
RECRUITING
Pickering
Royal Berkshire Hospital
RECRUITING
Reading
Alexandra Hospital
RECRUITING
Redditch
The Royal Shrewsbury Hospital
RECRUITING
Shrewsbury
Great Western Hospital
RECRUITING
Swindon
Royal Cornwall Hospital
NOT_YET_RECRUITING
Truro
Contact Information
Primary
Boehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127
Time Frame
Start Date: 2024-08-13
Estimated Completion Date: 2028-08-30
Participants
Target number of participants: 11000
Treatments
Other: Part 1: Run-in period (all participants)
Eligible participants will enter a Run-in period during which they will receive placebo matching BI 690517 + empagliflozin.
Experimental: Part 2: Randomized treatment, follow-up period, treatment group
Placebo_comparator: Part 2: Follow-up period, placebo group
Sponsors
Leads: Boehringer Ingelheim

This content was sourced from clinicaltrials.gov

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