En undersøgelse for at lære, hvor godt behandlingskombinationen af finerenon og empagliflozin virker, og hvor sikker den er sammenlignet med hver enkelt behandling alene hos voksne deltagere med langvarig nyresygdom (kronisk nyresygdom) og type 2-diabetes (CONFIDENCE)
16. juni 2026 opdateret af: Bayer
En parallelgruppebehandling, fase 2, dobbeltblind, tre-armsundersøgelse for at vurdere effektiviteten og sikkerheden af finerenon plus empagliflozin sammenlignet med enten finerenon eller empagliflozin hos deltagere med kronisk nyresygdom og type 2-diabetes
Finerenon virker ved at blokere en gruppe af proteiner, kaldet mineralocorticoid receptor. En øget stimulering af mineralocorticoid-receptoren er kendt for at udløse skader og betændelse i nyren og menes derfor at spille en rolle ved CKD.
Empagliflozin sænker blodsukkerniveauet ved at øge udskillelsen af glukose fra blodet til urinen.
I denne undersøgelse ønsker forskerne at lære, hvor godt kombinationen af finerenon og empagliflozin hjælper med at bremse forværringen af deltagernes nyrefunktion sammenlignet med begge behandlinger alene. Til dette vil niveauet af protein i urinen blive målt. Efterforskerne ønsker også at vide, hvor sikker kombinationen er sammenlignet med begge behandlinger alene.
Afhængigt af behandlingsgruppen vil deltagerne enten tage kombinationen af finerenon og empagliflozin eller finerenon sammen med placebo eller empagliflozin sammen med placebo én gang dagligt som tabletter gennem munden. En placebo ligner en behandling, men der er ingen medicin i sig. Det er vigtigt, at deltagerne også fortsætter med at tage deres anden nuværende medicin mod CKD og T2D.
Deltagerne vil være i undersøgelsen i op til 7,5 måneder og vil tage undersøgelsesbehandlingerne i 6 måneder. I løbet af undersøgelsen vil deltagerne besøge undersøgelsesstedet 7 gange.
Studieholdet vil:
- tage blod- og urinprøver
- kontrollere deltagernes vitale funktioner
- lav en fysisk undersøgelse inklusive højde og vægt
- kontrollere deltagernes hjertesundhed ved hjælp af et elektrokardiogram (EKG)
- overvåge deltagernes blodtryk
- Stil deltagerne spørgsmål om, hvordan de har det, og hvilke uønskede hændelser de kan have. En uønsket hændelse er ethvert problem, der opstår under forsøget. Læger holder styr på alle hændelser, der sker i forsøg, selvom de ikke tror, hændelserne kan være relateret til undersøgelsesbehandlingerne.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
1664
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Ghent, Belgien, 9000
- UZ Gent
-
Ieper, Belgien, 8900
- Jan Yperman Ziekenhuis
-
Kortrijk, Belgien, 8500
- AZ Groeninge Campus Kennedylaan
-
Leuven, Belgien, 3000
- UZ Leuven Gasthuisberg
-
Roeselare, Belgien, 8800
- AZ Delta
-
-
Hainaut
-
Lodelinsart, Hainaut, Belgien, 6042
- CHU de Charleroi Hôpital civil
-
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Oost-vlaanderen
-
Aalst, Oost-vlaanderen, Belgien, 9300
- Onze-Lieve-Vrouwziekenhuis (OLVZ) - Campus Aalst
-
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-
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Ontario
-
Hamilton, Ontario, Canada, L8M 1K7
- Hamilton Medical Research Group
-
Mississauga, Ontario, Canada, L5H4K9
- William Osler Health centre, Sakuara Medical
-
Sarnia, Ontario, Canada, N7T 4X3
- Bluewater Clinical Research Group
-
Waterloo, Ontario, Canada, N2J 1C4
- Sameh Fikry Professional Corporation
-
Waterloo, Ontario, Canada, N2T 0C1
- Clinical Research Solutions, Inc.
-
-
Quebec
-
Montreal, Quebec, Canada, H1M 1B1
- GCP Research | Montreal
-
Montreal, Quebec, Canada, H2X 0A9
- Centre Hospitalier de l'Universite de Montreal (CHUM) | Cardiology
-
Saint-Laurent, Quebec, Canada, H4T 1Z9
- LMC Clinical Research Inc. Montreal
-
-
-
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Capital Region
-
Copenhagen, Capital Region, Danmark, 2400
- Bispebjerg Hospital - Hjerteafdeling
-
Herlev, Capital Region, Danmark, 2730
- Steno Diabetes Center Copenhagen | Herlev - Clinical and Translational Research Department
-
-
Central Jutland
-
Herning, Central Jutland, Danmark, 7400
- Region Midtjylland | Regionshospitalet Godstrup - Nephrology Department
-
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Region Syddanmark
-
Esbjerg, Region Syddanmark, Danmark, 6700
- Hospital of South West Jutland | Department of Endocrinology Research
-
-
-
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Arizona
-
Surprise, Arizona, Forenede Stater, 85374
- Southwest Kidney Institute, PLC - Suprise
-
-
California
-
Los Angeles, California, Forenede Stater, 90022
- Academic Medical Research Institute
-
Northridge, California, Forenede Stater, 91325
- Dignity Health Northridge Hospital Medical Center - Nephrology
-
Sylmar, California, Forenede Stater, 91342-1437
- Olive View - UCLA Medical Center
-
Vallejo, California, Forenede Stater, 94592
- Touro University California - Metabolic Research Center
-
-
Florida
-
Delray Beach, Florida, Forenede Stater, 33445
- Florida Kidney Physicians - Delray Beach Nephrology
-
Ocoee, Florida, Forenede Stater, 34761
- West Orange Endocrinology & Clinical Research
-
Port Charlotte, Florida, Forenede Stater, 33952
- Innovative Research Institute
-
West Palm Beach, Florida, Forenede Stater, 33401
- Metabolic Research Institute, Inc.
-
-
Georgia
-
Atlanta, Georgia, Forenede Stater, 30303
- Grady Memorial Hospital - Endocrinology
-
East Point, Georgia, Forenede Stater, 30344
- Southeast Kidney Associates - East Point
-
Savannah, Georgia, Forenede Stater, 31406
- Velocity Clinical Research - Savannah
-
-
Louisiana
-
Metairie, Louisiana, Forenede Stater, 70006
- NOLA Care Clinical Research
-
Metairie, Louisiana, Forenede Stater, 70006
- Omega Clinical Research - Metairie
-
-
Massachusetts
-
Plymouth, Massachusetts, Forenede Stater, 02360
- South Shore Nephrology
-
-
Michigan
-
Saint Joseph, Michigan, Forenede Stater, 49085
- Lake Michigan Nephrology
-
Troy, Michigan, Forenede Stater, 48085
- Oakland Medical Research
-
-
Missouri
-
Kansas City, Missouri, Forenede Stater, 64128
- Kansas City VA Medical Center - Endocrinology
-
Kansas City, Missouri, Forenede Stater, 64111
- Clinical Research Consultants, a JCCT Company
-
St Louis, Missouri, Forenede Stater, 63136
- St. Louis Heart and Vascular, PC - Christian Hospital Office
-
St Louis, Missouri, Forenede Stater, 63110
- Center for Advanced Medicine - Diabetes Center
-
-
Nebraska
-
Lincoln, Nebraska, Forenede Stater, 68510
- Somnos Clinical Research
-
-
Nevada
-
Las Vegas, Nevada, Forenede Stater, 89102
- Healor Primary Care / CCT Research
-
Las Vegas, Nevada, Forenede Stater, 89119
- CCT Research - Santa Rosa Medical Centers of Nevada
-
-
New York
-
Middletown, New York, Forenede Stater, 10941
- Circuit Clinical/Crystal Run
-
-
North Carolina
-
Asheboro, North Carolina, Forenede Stater, 27203
- Randolph Health Internal Medicine in Asheboro
-
Chapel Hill, North Carolina, Forenede Stater, 27514
- UNC Hospitals Outpatient Center at Eastowne - Nephrology
-
Greenville, North Carolina, Forenede Stater, 27834
- Eastern Nephrology Associates - Greenville West
-
Hendersonville, North Carolina, Forenede Stater, 28792
- Blue Sky, MD/ Lamond Family Medicine
-
Kinston, North Carolina, Forenede Stater, 28504
- Eastern Nephrology Associates - Kinston
-
-
Ohio
-
Cincinnati, Ohio, Forenede Stater, 45242
- Velocity Clinical Research - Blue Ash
-
-
South Dakota
-
Dakota Dunes, South Dakota, Forenede Stater, 57049
- Dunes Clinical Research LLC
-
-
Tennessee
-
Memphis, Tennessee, Forenede Stater, 38119
- DarSalud Care / LifeDOC Research
-
Memphis, Tennessee, Forenede Stater, 38163
- The University of Tennessee Health Science Center - Medical Center Clinic - Nephrology
-
-
Texas
-
Corpus Christi, Texas, Forenede Stater, 78414
- Office of Osvaldo A. Brusco, MD
-
Dallas, Texas, Forenede Stater, 75208
- Thyroid, Endocrinology, and Diabetes - Dallas
-
El Paso, Texas, Forenede Stater, 79925
- DaVita Clinical Research- El Paso
-
Houston, Texas, Forenede Stater, 77008
- Global Kidney Center
-
Houston, Texas, Forenede Stater, 77024-2593
- Victorium Clinical Research
-
Lewisville, Texas, Forenede Stater, 75057
- North Texas Kidney Disease Associates Lewisville
-
McAllen, Texas, Forenede Stater, 78503
- Biopharma Informatic - McAllen, TX
-
San Antonio, Texas, Forenede Stater, 78212
- Clinical Advancement Center, PLLC
-
San Antonio, Texas, Forenede Stater, 78229
- UT Health San Antonio - Medical Arts & Research Center - Endocrinology
-
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Utah
-
Salt Lake City, Utah, Forenede Stater, 84117
- Olympus Family Medicine
-
-
Virginia
-
Salem, Virginia, Forenede Stater, 24153
- Salem VA Medical Center - Endocrinology
-
-
Washington
-
Spokane, Washington, Forenede Stater, 99202
- MultiCare Rockwood Clinic Diabetes & Endocrinology Center
-
-
-
-
-
Many Locations, Frankrig
- Many locations
-
-
Auvergne-Rhône-Alpes
-
La Tronche (Grenoble Area), Auvergne-Rhône-Alpes, Frankrig, 38043
- Center Hospitalier Michallon - Grenoble
-
Lyon, Auvergne-Rhône-Alpes, Frankrig, 69003
- Hôpital Edouard Herriot - Lyon Cedex
-
-
Bourgogne-Franche-Comté
-
Dijon, Bourgogne-Franche-Comté, Frankrig, 21000
- CHU Dijon - Hopital Francois Miterrand
-
-
Occitanie
-
Nîmes, Occitanie, Frankrig, 30029
- Hopital Carémeau - Nîmes
-
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Île-de-France Region
-
Paris, Île-de-France Region, Frankrig, 75014
- Hopital Saint Joseph
-
-
-
-
Gelderland
-
Apeldoorn, Gelderland, Holland, 7334 DZ
- Gelre Ziekenhuizen
-
-
North Holland
-
Amsterdam, North Holland, Holland, 1091 AC
- Onze Lieve Vrouwe Gasthuis
-
-
South Holland
-
Dordrecht, South Holland, Holland, 3318 AT
- Albert Schweitzer Ziekenhuis | Dordwijk - Cardiology Department
-
-
Utrecht
-
Amersfoort, Utrecht, Holland, 3818 TZ
- Meander Medisch Centrum
-
-
-
-
-
Bengaluru, Indien, 560076
- Dr. Bantwal's Clinic
-
Bengaluru, Indien
- Bangalore Medical College & Research Institute
-
Cuttack, Indien
- Sriram Chandra Bhanj Medical College & Hospital
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Nagpur, Indien, 440009
- Government Medical College and Hospital (GMCH) Nagpur
-
New Delhi, Indien, 110017
- Max Super Speciality Hospital (MSSH) - Saket
-
Pune, Indien, 411057
- Lifepoint Multispecialty Hospital
-
-
Andhra Pradesh
-
Visakhapatnam, Andhra Pradesh, Indien, 530002
- King George Hospital
-
-
Gujarat
-
Ahmedabad, Gujarat, Indien, 380052
- Mavani Dialysis & Kidney Center
-
Vadodara, Gujarat, Indien, 390007
- Vedanta Kidney Care
-
-
Karnataka
-
Belagavi, Karnataka, Indien, 590010
- K.L.E.S. Dr. Prabhakar Kore Hospital & Medical Research Centre
-
Mangalore, Karnataka, Indien, 575003
- Vinaya Hospital and Research Centre (A Unit of KIMS)
-
Mysore, Karnataka, Indien, 570015
- Manipal Hospital
-
-
Kerala
-
Kozhikode, Kerala, Indien, 673008
- Government Medical College
-
-
Maharashtra
-
Mumbai, Maharashtra, Indien, 400012
- Seth Gordhandas Sunderdas Medical College (GSMC) - King Edward Memorial (KEM) Hospital
-
Nagpur, Maharashtra, Indien, 440010
- Asian Kidney Hospital And Medical Centre
-
Pune, Maharashtra, Indien, 411001
- Grant Medical Foundation - Ruby Hall Clinic (RHC)
-
-
National Capital Territory of Delhi
-
Bhubaneswar, National Capital Territory of Delhi, Indien, 751019
- All India Institute of Medical Sciences
-
New Delhi, National Capital Territory of Delhi, Indien, 110076
- Indraprastha Apollo Hospital
-
-
Rajasthan
-
Jaipur, Rajasthan, Indien, 302017
- Sawami Man Singh (SMS) Medical College & Attached Hospitals
-
Jaipur, Rajasthan, Indien, 302020
- Eternal Heart Care Centre (EHCC) and Research Institute
-
-
Tamil Nadu
-
Chennai, Tamil Nadu, Indien, 600010
- Government Kilpauk Medical College Hospital
-
-
Telangana
-
Hyderabad, Telangana, Indien, 500082
- Nizam's Institute of Medical Sciences (NIMS)
-
Secunderabad, Telangana, Indien, 500003
- Krishna Institute Of Medical Science
-
Telangana, Telangana, Indien, 500012
- Osmania General Hospital
-
-
Uttar Pradesh
-
Kanpur, Uttar Pradesh, Indien, 208002
- G.S.V.M. Medical College
-
-
West Bengal
-
Kolkata, West Bengal, Indien, 700020
- Institute of Post-Graduate Medical Education and Research
-
-
-
-
-
Afula, Israel, 1834111
- HaEmek Medical Center | Internal Medicine C Department - Research Unit
-
Ashkelon, Israel, 7830604
- Barzilai Medical Center | Department of Nephrology and Hypertension
-
Beersheba, Israel, 8410101
- Clalit Health | Soroka Medical Center - Internal Medicine Department
-
Holon, Israel, 5822012
- Edith Wolfson Medical Center | Internal Medicine Department
-
Jerusalem, Israel, 911200
- Hadassah University Medical Center (HUMC)
-
Nahariya, Israel, 2210001
- Health Corporation of Galilee Medical Center
-
Safed, Israel, 1311001
- Health Corporation of the Ziv Medical Center (R.A.)
-
-
-
-
-
Chieti, Italien, 66100
- Università degli Studi "G. D'Annunzio" di Chieti - Endocrinologia
-
Many Locations, Italien
- Many locations
-
-
Apulia
-
San Giovanni Rotondo, Apulia, Italien, 71013
- Casa Sollievo della Sofferenza - Endocrinologia
-
-
Emilia-Romagna
-
Parma, Emilia-Romagna, Italien, 43126
- Azienda Ospedaliero Universitaria Parma - SC Nefrologia
-
-
Liguria
-
Chiavari, Liguria, Italien, 16043
- ASL N 4 SSR Liguria_Ospedale di Chiavari - Diabetologia e Malattie Metaboliche
-
-
Lombardy
-
Bergamo, Lombardy, Italien, 24127
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - Malattie Endocrine e Diabetologia
-
Milan, Lombardy, Italien, 20122
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Endocrinologia
-
Milan, Lombardy, Italien, 20132
- Ospedale San Raffaele S.r.l. - Medicina Generale Indirizzo Diabetologico ed Endocrino-Metabolico
-
Milan, Lombardy, Italien, 20142
- Azienda Socio Sanitaria Territoriale Santi Paolo e Carlo_Ospedale S. Paolo - Gestione integrata della malattia Diabetica
-
Rho, Lombardy, Italien, 20017
- Azienda Socio Sanitaria Territoriale Rhodense
-
-
Piedmont
-
Orbassano, Piedmont, Italien, 10043
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga - Malattie Metaboliche Diabetologia
-
-
Sardinia
-
Olbia, Sardinia, Italien, 07026
- Azienda Socio Sanitaria Locale N 2 Della Gallura - Diabetologia
-
-
Tuscany
-
Pisa, Tuscany, Italien, 56124
- Azienda Ospedaliero Universitaria Pisana_Cisanello - Malattie Metaboliche e Diabetologia
-
-
-
-
-
Many Locations, Japan
- Many locations
-
-
Ehime
-
Matsuyama, Ehime, Japan, 791-8026
- Saiseikai Matsuyama Hospital
-
-
Fukui
-
Fukui-shi, Fukui, Japan, 918-8503
- Fukui-ken Saiseikai Hospital
-
-
Fukuoka
-
Chikushino-shi, Fukuoka, Japan, 818-8502
- Fukuoka University Chikushi Hospital
-
Fukuoka, Fukuoka, Japan, 811-0213
- Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital
-
Kitakyushu, Fukuoka, Japan, 802-8555
- Kokura Memorial Hospital
-
Kitakyushu, Fukuoka, Japan, 807-0857
- Hirohata Naika Clinic
-
-
Hokkaido
-
Obihiro, Hokkaido, Japan, 080-0848
- Jiyugaoka Yamada Internal Medicine Clinic
-
-
Ibaraki
-
Naka, Ibaraki, Japan, 311-0113
- Naka Kinen Clinic
-
-
Ishikawa-ken
-
Hakusan, Ishikawa-ken, Japan, 924-8588
- Public Central Hospital of Matto Ishikawa | Clinical Trial Management Office
-
-
Osaka
-
Osaka, Osaka, Japan, 558-8558
- Osaka General Medical Center
-
Osaka, Osaka, Japan, 530-0001
- Medical Corporation Taifukukai, Osaka Nishiumeda Clinic
-
-
-
-
-
Many Locations, Spanien
- Many locations
-
-
A Coruña
-
A Coruña, A Coruña, Spanien, 15006
- Complexo Hospitalario Universitario A Coruna | Endocrinologia y Nutricion
-
Ferrol, A Coruña, Spanien, 15405
- Area Sanitaria De Ferrol | Medicina Interna
-
-
Barcelona
-
Barcelona, Barcelona, Spanien, 08035
- Hospital Universitari Vall D Hebron | Nefrologia
-
Barcelona, Barcelona, Spanien, 8023
- Hospital Quironsalud Barcelona | Internal Medicine Department
-
-
Granada
-
Granada, Granada, Spanien, 18014
- Hospital Universitario Virgen De Las Nieves | Medicina Interna
-
-
Madrid
-
Alcalá de Henares, Madrid, Spanien, 28805
- Hospital Universitario Principe De Asturias | Nefrologia
-
Madrid, Madrid, Spanien, 28040
- Hospital Universitario Fundacion Jimenez Diaz | Nephrology and Hypertension Department
-
Majadahonda, Madrid, Spanien, 28222
- Hospital Universitario Puerta De Hierro De Majadahonda | Nefrologia
-
-
Málaga
-
Málaga, Málaga, Spanien, 20910
- Hospital Universitario Virgen De La Victoria | Endocrinologia y Nutricion
-
-
Sevilla
-
Castilleja de la Cuesta, Sevilla, Spanien, 41950
- Hospital Nisa Sevilla Aljarafe | Endocrinologia y Nutricion
-
-
Valencia
-
Valencia, Valencia, Spanien, 46010
- Hospital Clinico Universitario De Valencia | Cardiologia
-
Valencia, Valencia, Spanien, 46017
- Hospital Universitario Dr Peset Aleixandre | Nefrologia
-
-
-
-
-
Gyeonggi-do, Sydkorea, 425-707
- Ansan Hospital | Nephrology
-
Seoul, Sydkorea, 5278
- Kyung Hee University Hospital at Gangdong
-
Seoul, Sydkorea, 7442
- Hallym University Kangnam Sacred Heart Hospital
-
-
Chungcheongnam-do
-
Cheonan, Chungcheongnam-do, Sydkorea, 31151
- Soon Chun Hyang University Cheonan Hospital
-
-
Gang''Weondo
-
Wŏnju, Gang''Weondo, Sydkorea, 26426
- Yonsei University Wonju Christian Hospital
-
-
Gyeonggi-do
-
Guri-si, Gyeonggi-do, Sydkorea, 471-701
- Hanyang University Guri Hospital
-
-
Gyeonggido
-
Anyang-si, Gyeonggido, Sydkorea, 14068
- Hallym University Sacred Heart Hospital
-
Seongnam-si, Gyeonggido, Sydkorea, 13620
- Seoul National University Bundang Hospital
-
-
Incheon Gwang''Yeogsi
-
Incheon, Incheon Gwang''Yeogsi, Sydkorea, 21431
- The Catholic University of Korea, Incheon St.Mary's Hospital
-
-
Seoul Teugbyeolsi
-
Seoul, Seoul Teugbyeolsi, Sydkorea, 3080
- Seoul National University Hospital
-
Seoul, Seoul Teugbyeolsi, Sydkorea, 03722
- Severance Hospital, Yonsei University Health System
-
Seoul, Seoul Teugbyeolsi, Sydkorea, 05505
- Asan Medical Center | Ophthalmology
-
-
-
-
-
Many Locations, Taiwan
- Many locations
-
Taichung, Taiwan, 404327
- China Medical University Hospital
-
-
Changhua
-
Changhua, Changhua, Taiwan, 50006
- Changhua Christian Hospital
-
-
Kaohsiung
-
Kaohsiung City, Kaohsiung, Taiwan, 833
- Chang Gung Memorial Hospital Kaohsiung
-
-
New Taipei
-
New Taipei City, New Taipei, Taiwan, 220
- Far Eastern Memorial Hospital | Nephrology Department
-
New Taipei City, New Taipei, Taiwan, 23561
- Taipei Medical University - Shuang Ho Hospital
-
-
Taichung
-
Taichung, Taichung, Taiwan, 40705
- Taichung Veterans General Hospital
-
-
Taipei
-
Taipei, Taipei, Taiwan, 11217
- Taipei Veterans General Hospital
-
-
-
-
Free and Hanseatic City of Hamburg
-
Hamburg, Free and Hanseatic City of Hamburg, Tyskland, 22041
- Diabetes Zentrum Wandsbek
-
-
Hesse
-
Frankfurt am Main, Hesse, Tyskland, 60596
- ClinPhenomics GmbH&Co. KG
-
-
North Rhine-Westphalia
-
Dortmund, North Rhine-Westphalia, Tyskland, 44137
- Diabetologische Schwerpunkt Praxis Dortmund
-
-
Rhineland-Palatinate
-
Ludwigshafen am Rhein, Rhineland-Palatinate, Tyskland, 67059
- Zentrum für Diabetologie und Ernährungsmedizin
-
-
Saxony
-
Pirna, Saxony, Tyskland, 1796
- Cardiologicum Pirna / Dresden-Seidnitz
-
-
State of Berlin
-
Berlin, State of Berlin, Tyskland, 12203
- Charité Campus Benjamin Franklin (CBF)
-
-
Thuringia
-
Jena, Thuringia, Tyskland, 7747
- Friedrich-Schiller-Uni. Jena
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
Deltager med en klinisk diagnose af kronisk nyresygdom (CKD) og følgende:
- I del A: eGFR 40-90 ml/min/1,73m^2 (hvor ikke mere end 20 % har en eGFR >75 ml/min/1,73m^2) ved brug af Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) formel ved screeningsbesøg og mindst én historisk værdi af eGFR <60 mL/min/1,73 m^2 inden for 3 måneder eller har en registreret diagnose af CKD.
- I del B: eGFR 30-90 ml/min/1,73m^2 (hvor ikke mere end 20 % har en eGFR >75 ml/min/1,73m^2) ved brug af CKD-EPI-formel ved screeningsbesøg og mindst én historisk værdi af eGFR <60 ml/min/1,73 m^2 inden for 3 måneder eller have en registreret diagnosticering af CKD.
- 300 ≤UACR <5000 mg/g ved screeningsbesøg (middelværdi fra 3 morgenprøver) og dokumentation for albuminuri/proteinuri (kvantitativ eller semikvantitativ måling) i deltagerens journal mindst 3 måneder før screening
- Deltager med type 2-diabetes (T2D) som defineret af American Diabetes Association (ADA 2021), med glykeret hæmoglobin (HbA1c) ved screening <11 %.
- Deltager behandlet med den klinisk maksimalt tolererede dosis, ifølge investigators vurdering, af angiotensin-konverterende enzymhæmmer (ACEi) eller angiotensinreceptorblokker (ARB), men ikke begge, i mere end 1 måned ved screeningsbesøg.
Ekskluderingskriterier:
- Deltagere med type 1 diabetes (T1D).
- Deltager med leverinsufficiens klassificeret som Child-Pugh C.
- Deltager med blodtryk på dag 1 besøg højere end 160/100 eller systolisk blodtryk lavere end 90 mmHg.
- Deltager, der i øjeblikket er behandlet med en natrium/glukose cotransporter-2-hæmmer (SGLT2i) eller SGLT-1/2i, eller som har modtaget en SGLT2i eller SGLT-1/2i, som ikke kan afbrydes mindst 8 uger før screeningsbesøget og under undersøgelsens interventionsbehandling .
- Deltager behandlet med en anden mineralokortikoid receptorantagonist (MRA) (f.eks. eplerenon, esaxerenon, spironolacton, canrenon), en reninhæmmer, kaliumtilskud, et kaliumbesparende diuretikum (f.eks. amilorid, triamteren), et kalium-angiotensin-bindemiddel eller receptor neprilysinhæmmer (ARNI), som ikke kan seponeres mindst 8 uger før screeningsbesøget og under undersøgelsesinterventionsbehandling.
- Deltagere, der i øjeblikket er behandlet, eller som blev behandlet med Finerenone (Kerendia©) inden for 8 uger før screeningsbesøget.
- Deltager med serum/plasma kalium (K+) over 4,8 mmol/L ved screening.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Finerenone og Empagliflozin
Deltagerne vil tage Finerenone (10 eller 20 mg én gang dagligt [OD]) og Empagliflozin (10 mg OD) i op til 180 dage.
|
oral administration en gang dagligt
oral administration én gang dagligt, hvis resultaterne af screening af eGFR (estimeret glomerulær filtrationshastighed) er:
oral administration én gang dagligt, hvis resultaterne af screening af eGFR (estimeret glomerulær filtrationshastighed) er: ≥60 ml/min/1,73
m2
|
|
Eksperimentel: Finerenone og Empagliflozin placebo
Deltagerne vil tage Finerenone (10 eller 20 mg OD) og matchende placebo til Empagliflozin (OD) i op til 180 dage.
|
oral administration én gang dagligt, hvis resultaterne af screening af eGFR (estimeret glomerulær filtrationshastighed) er:
oral administration én gang dagligt, hvis resultaterne af screening af eGFR (estimeret glomerulær filtrationshastighed) er: ≥60 ml/min/1,73
m2
Matchende placebo til oral administration af empagliflozin én gang dagligt
|
|
Eksperimentel: Empagliflozin og Finerenone placebo
Deltagerne vil tage Empagliflozin (10 mg OD) og matchende placebo til Finerenone (OD).
i op til 180 dage.
|
oral administration en gang dagligt
Matchende placebo med Finerenone oral administration én gang dagligt
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Least Squares Mean Ratio of Urinary Albumin-to-Creatinine Ratio (UACR) at Day 180 Relative to Baseline in the Combination Therapy Group Versus Empagliflozin Alone
Tidsramme: Baseline and Day 180
|
Least squares mean ratio of urinary albumin-to-creatinine ratio (UACR) at Day 180 relative to baseline, estimated using a mixed model for repeated measures.
The treatment effect is expressed as the ratio of LS means for the combination therapy group compared with empagliflozin alone.
A ratio below 1 indicates a reduction in UACR relative to baseline.
UACR is a marker of albuminuria and a predictor of long-term renal and cardiovascular outcomes in participants with chronic kidney disease and type 2 diabetes.
|
Baseline and Day 180
|
|
Least Squares Mean Ratio of Urinary Albumin-to-Creatinine Ratio (UACR) at Day 180 Relative to Baseline in the Combination Therapy Group Versus Finerenone Alone
Tidsramme: Baseline and Day 180
|
Least squares mean ratio of urinary albumin-to-creatinine ratio (UACR) at Day 180 relative to baseline in the combination therapy group compared with finerenone alone, estimated using a mixed model for repeated measures.
A ratio below 1 indicates a reduction in UACR relative to baseline.
UACR is a measurement of albuminuria and a predictor of long-term renal and cardiovascular outcomes in participants with type 2 diabetes.
|
Baseline and Day 180
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Least Squares Mean Ratio of Urinary Albumin-to-Creatinine Ratio (UACR) at Day 210 Relative to Day 180
Tidsramme: Up to 210 days
|
Least squares mean ratio of urinary albumin-to-creatinine ratio (UACR) at Day 210 (30 days after stopping the treatment) relative to Day 180, estimated using a mixed model for repeated measures.
A ratio above 1 indicates an increase in UACR at Day 210 compared with Day 180.
UACR is a measurement of albuminuria, a predictor of long-term renal and cardiovascular outcomes in participants with type 2 diabetes.
|
Up to 210 days
|
|
Least Squares Mean Ratio of Urinary Albumin-to-Creatinine Ratio (UACR) at 30 Days After End of Treatment Relative to Baseline
Tidsramme: Baseline to Day 210 (30 days after End of Treatment)
|
Least squares mean ratio of urinary albumin-to-creatinine ratio (UACR) relative to baseline, estimated using a mixed model for repeated measures.
A ratio below 1 indicates a reduction in UACR relative to baseline.
UACR is a marker of albuminuria and a predictor of long-term renal and cardiovascular outcomes in participants with type 2 diabetes.
|
Baseline to Day 210 (30 days after End of Treatment)
|
|
Number of Participants by Relative Change in UACR Category at Day 180 (>30%, >40%, >50%)
Tidsramme: At Day 180
|
This outcome summarizes the number of participants whose relative change from baseline in urine albumin-to-creatinine ratio (UACR) at Day 180 met prespecified category thresholds (>30%, >40%, or >50%).
Relative change was assessed based on baseline and post-baseline UACR measurements.
Percentages were calculated using as denominator the number of participants with both a baseline and at least one post-baseline UACR assessment within the specified timeframe.
Participants were classified independently within each category.
|
At Day 180
|
|
Change From Baseline in eGFR at 30 Days
Tidsramme: At Day 30
|
Change from baseline to Day 30 in estimated glomerular filtration rate (eGFR) was evaluated for each treatment group.
Change was calculated as the value at Day 30 minus the baseline value.
Negative values indicate a decrease from baseline and positive values indicate an increase from baseline.
|
At Day 30
|
|
Number of Participants With an eGFR Decline Greater Than 30% at 30 Days From Baseline
Tidsramme: Up to 30 days
|
Up to 30 days
|
|
|
Change in eGFR at 180 Days and 210 Days From Day 30
Tidsramme: At Day 180 and Day 210
|
Change in estimated glomerular filtration rate (eGFR) from Day 30 to Day 180 and Day 210 was evaluated for each treatment group.
Change was calculated as the value at Day 180 or Day 210 minus the value at Day 30.
Positive values indicate an increase from Day 30 and negative values indicate a decrease from Day 30.
|
At Day 180 and Day 210
|
|
Number of Participants With AKI Events
Tidsramme: Up to 180 days
|
AKI is defined as any of the following:
|
Up to 180 days
|
|
Total Number of AKI Events
Tidsramme: Up to 180 days
|
AKI is defined as any of the following:
|
Up to 180 days
|
|
Number of Participants With Hyperkalemia Events (Moderate Hyperkalemia [5.5 <K+ ≤6.0 mmol/L], Severe Hyperkalemia [K+ >6.0 mmol/L])
Tidsramme: Up to 180 days
|
Moderate hyperkalemia was defined as K+ >5.5 to ≤6.0 mmol/L and severe hyperkalemia was defined as K+ >6.0 mmol/L).
|
Up to 180 days
|
|
Change From Baseline in K+
Tidsramme: At baseline, day 14 and day 180
|
Serum potassium values (mmol/L) were assessed at baseline and scheduled post-baseline visits.
Results are presented as observed mean potassium concentrations at each time point.
|
At baseline, day 14 and day 180
|
|
Number of Participants With Symptomatic Hypotension Events
Tidsramme: Up to 180 days
|
Number of participants who experienced at least one symptomatic hypotension event during the study period
|
Up to 180 days
|
|
Total Number of Symptomatic Hypotension Events
Tidsramme: Up to 180 days
|
Symptomatic hypotension events were assessed at all study visits and were documented as adverse events.
The outcome represents the total number of symptomatic hypotension events reported during the study period.
|
Up to 180 days
|
|
Number of Participants With Genital Mycotic Events
Tidsramme: Up to 180 days
|
The outcome represents the number of participants who experienced at least one genital mycotic event during the study period.
|
Up to 180 days
|
|
Total Number of Genital Mycotic Events
Tidsramme: Up to 180 days
|
Occurrence of urinary tract infection events were assessed at all study visits and documented as AEs.
|
Up to 180 days
|
|
Number of Participants With Urosepsis and Pyelonephritis Events
Tidsramme: Up to 180 days
|
Up to 180 days
|
|
|
Total Number of Urosepsis and Pyelonephritis Events
Tidsramme: Up to 180 days
|
Occurrence of urosepsis and pyelonephritis events were assessed at all study visits and documented as AEs.
|
Up to 180 days
|
|
Number of Participants With Ketoacidosis Events
Tidsramme: Up to 180 days
|
Up to 180 days
|
|
|
Total Number of Ketoacidosis Events
Tidsramme: Up to 180 days
|
Occurrence of ketoacidosis events were assessed at all study visits and documented as AEs.
|
Up to 180 days
|
|
Number of Participants With Necrotizing Fasciitis of the Perineum Events
Tidsramme: Up to 180 days
|
Up to 180 days
|
|
|
Number of Participants With Severe Hypoglycemia Events
Tidsramme: Up to 180 days
|
Severe hypoglycemia was defined as glucose level of <3.0 mmol/L (<54 mg/dL) is sufficiently low to indicate serious, clinically important hypoglycemia.
In addition, severe hypoglycemia, as defined by the ADA denotes severe cognitive impairment requiring external assistance for recovery.
|
Up to 180 days
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Zachariah T, Radhakrishnan J. Potential Role of Mineralocorticoid Receptor Antagonists in Nondiabetic Chronic Kidney Disease and Glomerular Disease. Clin J Am Soc Nephrol. 2024 Nov 1;19(11):1499-1512. doi: 10.2215/CJN.0000000000000540. Epub 2024 Jul 22.
- Mottl A, Scott C, Green JB, Heerspink HJL, Mann JFE, McGill JB, Nangaku M, Rosenstock J, Rossing P, Li L, Li N, Vaduganathan M, Agarwal R; CONFIDENCE Trial Investigators. Baseline Kidney Function, Albuminuria, and Urine Albumin-Creatinine Ratio Reduction with Finerenone, Empagliflozin, or Both: Post Hoc Analyses of CONFIDENCE Trial. J Am Soc Nephrol. 2026 Apr 1;37(4):764-776. doi: 10.1681/ASN.0000000928. Epub 2025 Nov 6.
- Agarwal R, Correa-Rotter R, Navaneethan SD, Heerspink HJL, Weir MR, McGill JB, Mottl AK, Nangaku M, Rosenstock J, Rossing P, Vaduganathan M, Scott C, Li L, Brinker M, Kovesdy CP, Green JB, Mann JFE. Safety and Synergy of Finerenone and Empagliflozin in Lowering Blood Pressure. Hypertension. 2026 Jun 5. doi: 10.1161/HYPERTENSIONAHA.126.27036. Online ahead of print.
- Agarwal R, Correa-Rotter R, Navaneethan SD, Fukami K, Heerspink HJL, Mann JFE, McGill JB, Mottl AK, Nangaku M, Rosenstock J, Rossing P, Vaduganathan M, Scott C, Li L, Aldworth C, Green JB, Weir MR. Acute eGFR Changes and Their Mediation of Albuminuria Reduction with Empagliflozin and Finerenone. J Am Soc Nephrol. 2026 Mar 29. doi: 10.1681/ASN.0000001071. Online ahead of print.
- Agarwal R, Green JB, Heerspink HJL, McGill JB, Mottl A, Nangaku M, Rosenstock J, Rossing P, Vaduganathan M, Solis-Herrera C, Scott C, Li L, Brinker M, Aldworth C, Mann JFE. Risk of Hyperkalemia With Empagliflozin, Finerenone, or Both: Secondary Analysis of the CONFIDENCE Randomized Trial. J Am Coll Cardiol. 2026 Feb 24;87(7):772-784. doi: 10.1016/j.jacc.2025.10.049. Epub 2025 Nov 7.
- Agarwal R, Green JB, Heerspink HJL, Mann JFE, McGill JB, Mottl A, Osonoi T, Pal A, Rossing P, Rosenstock J, Vaduganathan M, Li L, Li N, Scott C, Manjrekar P, Yamashita S, Nangaku M. Impact of Simultaneous Initiation of Finerenone and Empagliflozin on Urinary Albumin-to-Creatinine Ratio in Asia: Pre-Specified Analysis of CONFIDENCE. Clin J Am Soc Nephrol. 2026 Jan 1;21(1):72-82. doi: 10.2215/CJN.0000000865. Epub 2025 Sep 18.
- Vaduganathan M, Green JB, Heerspink HJL, Kim SG, Mann JFE, McGill JB, Mottl A, Nangaku M, Rosenstock J, Rossing P, Li L, Li N, Rohwedder K, Scott C, Agarwal R. Simultaneous initiation of finerenone and empagliflozin across the spectrum of kidney risk in the CONFIDENCE trial. Nephrol Dial Transplant. 2025 Dec 23;41(1):161-170. doi: 10.1093/ndt/gfaf160.
- Agarwal R, Green JB, Heerspink HJL, Mann JFE, McGill JB, Mottl AK, Rosenstock J, Rossing P, Vaduganathan M, Brinker M, Edfors R, Li N, Scheerer MF, Scott C, Nangaku M; CONFIDENCE Investigators. Finerenone with Empagliflozin in Chronic Kidney Disease and Type 2 Diabetes. N Engl J Med. 2025 Aug 7;393(6):533-543. doi: 10.1056/NEJMoa2410659. Epub 2025 Jun 5.
- Agarwal R, Green JB, Heerspink HJL, Mann JFE, McGill JB, Mottl AK, Rosenstock J, Rossing P, Vaduganathan M, Brinker M, Edfors R, Li N, Scheerer MF, Scott C, Nangaku M; CONFIDENCE investigators. COmbinatioN effect of FInerenone anD EmpaglifloziN in participants with chronic kidney disease and type 2 diabetes using a UACR Endpoint (CONFIDENCE) trial: baseline clinical characteristics. Nephrol Dial Transplant. 2025 Aug 1;40(8):1559-1569. doi: 10.1093/ndt/gfaf022.
- Rossing P. Experimental Designs for Multicomponent Interventions in Kidney and Cardiometabolic Diseases. J Am Soc Nephrol. 2024 Oct 1;35(10):1438-1441. doi: 10.1681/ASN.0000000000000449. Epub 2024 Jul 5. No abstract available.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
23. juni 2022
Primær færdiggørelse (Faktiske)
14. marts 2025
Studieafslutning (Faktiske)
17. marts 2025
Datoer for studieregistrering
Først indsendt
4. februar 2022
Først indsendt, der opfyldte QC-kriterier
23. februar 2022
Først opslået (Faktiske)
24. februar 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Sygdomme i det endokrine system
- Patologiske processer
- Mandlige urogenitale sygdomme
- Nyresygdomme
- Urologiske sygdomme
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Kronisk sygdom
- Sygdomsegenskaber
- Metaboliske sygdomme
- Glukosemetabolismeforstyrrelser
- Diabetes mellitus
- Nyreinsufficiens
- Patologiske tilstande, tegn og symptomer
- Ernæringsmæssige og metaboliske sygdomme
- Diabetes mellitus, type 2
- Nyreinsufficiens, kronisk
- Natrium-Glucose Transporter 2-hæmmere
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Hypoglykæmiske midler
- Empagliflozin
- finereonon
Andre undersøgelses-id-numre
- 21839
- 2021-003037-11 (EudraCT nummer)
- 2023-506981-30-00 (Registry Identifier: CTIS)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
Tilgængeligheden af denne undersøgelses data vil senere blive bestemt i henhold til Bayers forpligtelse til EFPIA/PhRMA "Principles for ansvarlig deling af kliniske forsøgsdata". Dette vedrører omfang, tidspunkt og proces for dataadgang. Som sådan forpligter Bayer sig til efter anmodning fra kvalificerede forskere at dele kliniske forsøgsdata på patientniveau, kliniske forsøgsdata på undersøgelsesniveau og protokoller fra kliniske forsøg med patienter for lægemidler og indikationer godkendt i USA og EU efter behov for at udføre legitim forskning. Dette gælder data om nye lægemidler og indikationer, der er godkendt af EU's og amerikanske tilsynsmyndigheder den 1. januar 2014 eller senere.
Interesserede forskere kan bruge www.vivli.org til at anmode om adgang til anonymiserede data på patientniveau og understøttende dokumenter fra kliniske undersøgelser til at udføre forskning. Oplysninger om Bayer-kriterierne for notering af undersøgelser og anden relevant information findes i medlemssektionen på portalen.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .