- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05047263
Et forsøg for at lære, hvor godt finerenon virker, og hvor sikkert det er hos voksne deltagere med ikke-diabetisk kronisk nyresygdom (FIND-CKD)
Et randomiseret, dobbeltblindt, placebokontrolleret, parallelgruppe, multicenter fase 3-studie for at undersøge effektiviteten og sikkerheden af FINerenon, ud over standardbehandlingen, om udviklingen af nyresygdom hos patienter med ikke-diabetisk kronisk nyresygdom
Forskere leder efter en bedre måde at behandle mennesker, der har ikke-diabetisk kronisk nyresygdom (ikke-diabetisk CKD). Forsøgsbehandlingen, finerenon, udvikles til at hjælpe mennesker, der har langvarig nyresygdom, også kendt som kronisk nyresygdom (CKD). Det virker ved at blokere et bestemt hormon kaldet aldosteron, der forårsager skader og betændelse i hjertet og nyrerne, som vides at spille en rolle i CKD.
I dette forsøg ønsker forskerne at finde ud af, om finerenon hjælper med at bremse forværringen af deltagernes ikke-diabetiske CKD sammenlignet med placebo. En placebo ligner en prøvebehandling, men indeholder ingen medicin. Retssagen vil omfatte omkring 1.580 mænd og kvinder, der er mindst 18 år gamle.
Deltagerne vil tage finerenon eller placebo en gang om dagen som tabletter gennem munden. Alle deltagerne vil også fortsætte med at tage deres nuværende medicin mod deres CKD. Deltagerne vil være i forsøget i op til omkring 50 måneder.
Under forsøget vil lægerne indsamle blod- og urinprøver og kontrollere deltagernes helbred. Deltagerne vil også svare på spørgsmål om, hvordan de har det, og hvilke uønskede hændelser de oplever. En uønsket hændelse er et medicinsk problem, der opstår under forsøget. Læger holder styr på alle uønskede hændelser, der sker i forsøg, selvom de ikke mener, at de uønskede hændelser kan være relateret til forsøgets behandlinger.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
-
-
-
Buenos Aires, Argentina, C1061AAS
- Centro de Investigación y Prevención Cardiovascular
-
Córdoba, Argentina, X5016KET
- Clinica Privada Velez Sarsfield
-
Santa Fe, Argentina, 3000
- Clinica de Nefrologia Urologia y Enfermedades Cardiovascular
-
Santa Fe, Argentina, S3000FWO
- Centro de Investigaciones Clinicas del Litoral | Santa Fe, Argentina
-
-
Buenos Aires
-
Berazategui, Buenos Aires, Argentina, B1837
- Asociacion de Fomento y Sala de Primeros Auxilios Alberto Mignaburu | Berazategui, Argentina
-
Ciudad Autónoma de Buenos Aire, Buenos Aires, Argentina, C1056ABI
- Centro de Investigaciones Metabolicas | Ciudad de Autonoma de Buenos Aires, Argentina
-
Lanús, Buenos Aires, Argentina, B1824
- Centro de Investigaciones Medicas Lanus | Buenos Aires, Argentina
-
Mar del Plata, Buenos Aires, Argentina, B7600FZ0
- Instituto de Investigaciones Clinicas de Mar del Plata | Mar del Plata, Argentina
-
-
Ciudad Auton. de Buenos Aires
-
CABA, Ciudad Auton. de Buenos Aires, Argentina, C1018DES
- CEDIC Centro de Investigación Clínica | Buenos Aires, Argentina
-
-
San Luis Province
-
San Luis, San Luis Province, Argentina, D5700CGR
- Centro de Rehabilitacion Cardiovascular | San Luis, Argentina
-
-
-
-
New South Wales
-
Concord, New South Wales, Australien, 2139
- Concord Repatriation General Hospital
-
Kogarah, New South Wales, Australien, 2217
- St George Hospital
-
Wollongong, New South Wales, Australien, 2500
- Illawarra Shoalhaven Local Health District
-
-
Queensland
-
Birtinya, Queensland, Australien, 4575
- Sunshine Coast University Hospital
-
Woolloongabba, Queensland, Australien, 4102
- Princess Alexandra Hospital Australia
-
-
Victoria
-
Box Hill, Victoria, Australien, 3128
- Eastern Health Integrated Renal Service
-
Reservoir, Victoria, Australien, 3073
- Melbourne Renal Research Group
-
St Albans, Victoria, Australien, 3021
- Sunshine Hospital
-
-
-
-
-
Bruxelles - Brussel, Belgien, 1200
- CU Saint-Luc/UZ St-Luc
-
Ghent, Belgien, 9000
- UZ Gent
-
Leuven, Belgien, 3000
- UZ Leuven Gasthuisberg
-
Liège, Belgien, 4000
- CHU de Liege
-
Roeselare, Belgien, 8800
- AZ Delta / Nephrology
-
-
West-Vlaanderen
-
Kortrijk, West-Vlaanderen, Belgien, 8500
- AZ Groeninge Campus Kennedylaan | Nephrology
-
-
-
-
Burgas Province
-
Burgas, Burgas Province, Bulgarien, 8000
- Medical Center ''4Life''
-
-
Dobrich Province
-
Dobrich, Dobrich Province, Bulgarien, 9300
- Viva Phoenix Medical Center | Clinical Trials Department
-
-
Montana Province
-
Montana, Montana Province, Bulgarien, 3400
- Medical Center Hera | Montana Branch
-
-
Pernik Province
-
Pernik, Pernik Province, Bulgarien, 2300
- Multiprofile Hospital for Active Treatment Sveti Georgi OOD, Pernik - Department of Cardiology
-
-
Sofia City Province
-
Sofia, Sofia City Province, Bulgarien, 1618
- Diagnostic-Consultative Center XX | Nephrology Department
-
-
Stara Zagora Province
-
Stara Zagora, Stara Zagora Province, Bulgarien, 6010
- Medical Center Zara-Med EOOD | Nephrology Department
-
-
Veliko Tarnovo Province
-
Gorna Oryahovitsa, Veliko Tarnovo Province, Bulgarien, 5100
- Multiprofile Hospital for Active Treatment St. Ivan Rilski - Gorna Oryahovitsa | Nephrology Department
-
Veliko Tarnovo, Veliko Tarnovo Province, Bulgarien, 5600
- Medical Center ''Nevromedics''
-
-
-
-
-
Copenhagen, Danmark, 2100
- Rigshospitalet, Copenhagen University Hospital | Department of Nefrology
-
Esbjerg, Danmark, 6700
- Hospital of South West Jutland | Department of Endocrinology Research
-
Herlev, Danmark, 2730
- Herlev Hospital | Nephrology Department
-
Herning, Danmark, DK-7400
- Region Midtjylland | Regionshospitalet Godstrup - Nephrology Department
-
Holbæk, Danmark, 4300
- Region Sjælland | Holbaek Sygehus - Cardiology department
-
Odense C, Danmark, 5000
- Odense University Hospital | Department of Kidney Medicine
-
-
-
-
-
Gloucester, Det Forenede Kongerige, GL1 3NN
- Gloucestershire Hospitals NHS Foundation Trust | Gloucestershire Royal Hospital - Nephrology
-
-
Greater London
-
London, Greater London, Det Forenede Kongerige, E1 1BB
- Barts Health NHS Trust - Royal London Hospital - Nephrology
-
London, Greater London, Det Forenede Kongerige, SE5 9RS
- King's College Hospital NHS Foundation Trust | King's College Hospital - Nephrology Department
-
-
Kent
-
Canterbury, Kent, Det Forenede Kongerige, CT1 3NG
- Kent and Canterbury Hospital | Renal Research Delivery Team
-
-
South Yorkshire
-
Sheffield, South Yorkshire, Det Forenede Kongerige, S5 7AU
- Sheffield Teaching Hospitals NHS Foundation Trust | Northern General Hospital - NIHR Sheffield Clinical Research Facility
-
-
Wales
-
Cardiff, Wales, Det Forenede Kongerige, CF14 4XW
- Cardiff and Vale University Health Board | University Hospital of Wales - Nephrology and Transplant
-
-
-
-
Alabama
-
Huntsville, Alabama, Forenede Stater, 35805
- Nephrology Consultants, LLC
-
-
California
-
Chula Vista, California, Forenede Stater, 91910
- Balboa Research SMO+ - Chula Vista - West
-
El Centro, California, Forenede Stater, 92243
- Balboa Research SMO+ - El Centro
-
Los Angeles, California, Forenede Stater, 90095
- UCLA Clinical and Translational Research Center - Nephrology
-
Poway, California, Forenede Stater, 92064
- Balboa Nephrology Medical Group - Poway
-
San Dimas, California, Forenede Stater, 91773
- North America Research Institute - San Dimas
-
South Gate, California, Forenede Stater, 90280
- United Clinical Research & Innovations
-
-
Colorado
-
Aurora, Colorado, Forenede Stater, 80045
- University of Colorado | Renal Research Office
-
-
Connecticut
-
Middlebury, Connecticut, Forenede Stater, 55404
- DaVita Clinical Research | Middlebury, CT
-
New Haven, Connecticut, Forenede Stater, 06520
- Yale University | Nephrology Clinical Research
-
Waterbury, Connecticut, Forenede Stater, 06708
- Chase Medical Research, LLC
-
-
Florida
-
Boca Raton, Florida, Forenede Stater, 33431
- Research Physicians Network Alliance
-
Boca Raton, Florida, Forenede Stater, 33487
- Florida Kidney Physicians - Boca Raton
-
Orlando, Florida, Forenede Stater, 32804
- AdventHealth Translational Research Institute
-
-
Georgia
-
Atlanta, Georgia, Forenede Stater, 30303
- Grady Memorial Hospital - Endocrinology
-
Augusta, Georgia, Forenede Stater, 30904
- Southeastern Clinical Research Institute, LLC
-
Macon, Georgia, Forenede Stater, 31201
- Central Georgia Kidney Specialists - Macon
-
-
Idaho
-
Meridian, Idaho, Forenede Stater, 83642
- Frenova Renal Research | Boise Kidney and Hypertension
-
-
Illinois
-
Chicago, Illinois, Forenede Stater, 60643
- Research by Design, LLC | Chicago, IL
-
Chicago, Illinois, Forenede Stater, 60611
- Northwestern Medicine - Feinberg School of Medicine - Nephrology and Hypertension
-
Hinsdale, Illinois, Forenede Stater, 60521
- Nephrology Associates of Northern Illinois and Indiana - Hinsdale
-
-
Iowa
-
Iowa City, Iowa, Forenede Stater, 52242
- University of Iowa Health Care Medical Center - Cardiology
-
-
Kansas
-
Kansas City, Kansas, Forenede Stater, 66160
- KUMC Clinical and Translational Science Unit - Nephrology
-
Wichita, Kansas, Forenede Stater, 67214
- Kansas Nephrology Research Institute
-
Wichita, Kansas, Forenede Stater, 67214
- Wichita Nephrology Group, PA
-
-
Louisiana
-
Shreveport, Louisiana, Forenede Stater, 71101
- Northwest Louisiana Nephrology - Shreveport - 1800 Buckner St.
-
-
Maryland
-
Baltimore, Maryland, Forenede Stater, 21287
- Johns Hopkins Hospital - Nephrology
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02111
- Tufts Medical Center | Nephrology Department
-
-
Minnesota
-
Edina, Minnesota, Forenede Stater, 55435
- DaVita Clinical Research | Edina, MN
-
-
Mississippi
-
Jackson, Mississippi, Forenede Stater, 39216
- University Hospital - UMMC - Nephrology
-
-
Missouri
-
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
-
-
New Mexico
-
Albuquerque, New Mexico, Forenede Stater, 87131
- UNM Clinical and Translational Science Center - Nephrology
-
-
North Carolina
-
Asheville, North Carolina, Forenede Stater, 28801
- Mountain Kidney & Hypertension Associates
-
Chapel Hill, North Carolina, Forenede Stater, 27514
- UNC Hospitals Outpatient Center at Eastowne - Nephrology
-
Greenville, North Carolina, Forenede Stater, 27834
- East Carolina University | Nephrology & Hypertension
-
Wilmington, North Carolina, Forenede Stater, 28401
- Eastern Nephrology Associates | Wilmington
-
-
Ohio
-
Cleveland, Ohio, Forenede Stater, 44195
- Cleveland Clinic | Urological and Kidney Department
-
Cleveland, Ohio, Forenede Stater, 44106
- UH Cleveland Medical Center - Nephrology
-
-
Pennsylvania
-
Bethlehem, Pennsylvania, Forenede Stater, 18017
- Northeast Clinical Research Center | Bethlehem, PA
-
Danville, Pennsylvania, Forenede Stater, 17822
- Geisinger Medical Center - Nephrology
-
Philadelphia, Pennsylvania, Forenede Stater, 19140
- Temple Health - Nephrology
-
-
South Carolina
-
Orangeburg, South Carolina, Forenede Stater, 29118
- South Carolina Clinical Reserach
-
-
Tennessee
-
Knoxville, Tennessee, Forenede Stater, 37923
- Knoxville Kidney Center, PLLC
-
Nashville, Tennessee, Forenede Stater, 37232
- Vanderbilt University Medical Center - Nephrology Clinical Trials Center
-
-
Texas
-
Dallas, Texas, Forenede Stater, 75230
- Dallas Renal Group - Medical City
-
El Paso, Texas, Forenede Stater, 79902
- El Paso Medical Research Institute (MedResearch Inc) | El Paso, TX
-
Houston, Texas, Forenede Stater, 77054
- DaVita Clinical Research | Houston, TX
-
McAllen, Texas, Forenede Stater, 78503
- Gamma Medical Research, Inc.
-
San Antonio, Texas, Forenede Stater, 78212
- Clinical Advancement Center, PLLC
-
San Antonio, Texas, Forenede Stater, 78207
- Texas Diabetes Institute - Renal Clinic
-
Shenandoah, Texas, Forenede Stater, 77384
- DaVita Clinical Research | North Houston, TX
-
-
Utah
-
Salt Lake City, Utah, Forenede Stater, 84132
- University of Utah School of Medicine | Kidney Research Clinic
-
South Salt Lake, Utah, Forenede Stater, 84115
- Utah Kidney Research Institute | Salt Lake City, UT
-
-
Virginia
-
Fairfax, Virginia, Forenede Stater, 22033
- Nephrology Associates of Northern Virginia - Fair Oaks
-
Woodbridge, Virginia, Forenede Stater, 22192
- Mendez Center For Clinical Research | Woodbridge, VA
-
-
Washington
-
Spokane Valley, Washington, Forenede Stater, 99204
- Providence Medical Research Center
-
-
-
-
-
Arta, Grækenland, 47132
- General Hospital of Arta | Nephrology Department
-
Athens, Grækenland, 11527
- General Hospital of Athens Laiko
-
Athens, Grækenland, 11527
- Hippokration General Hospital of Athens
-
Heraklion, Grækenland, 71500
- University General Hospital of Heraklion-Nephrology Clinic
-
Ioannina, Grækenland, 45500
- University General Hospital Of Ioannina-Nephrology Clinic
-
Thessaloniki, Grækenland, 54642
- Ippokratio General Hospital Of Thessaloniki- 1st Department of Nephrology
-
Thessaloniki, Grækenland, 57010
- Geniko Nosokomeio Thessalonikis George Papanikolaou-Nephrology Department
-
-
Achaia
-
Pátrai, Achaia, Grækenland, 26504
- University General Hospital of Patras | Nephrology Clinic
-
-
Thessaloniki
-
Efkarpia, Thessaloniki, Grækenland, 56429
- General Hospital Of Thessaloniki Papageorgiou-Renal Department
-
-
-
-
Hong Kong Island
-
Sheung Wan, Hong Kong Island, Hong Kong, 00000
- Tung Wah Hospital
-
-
Hong Kong SAR
-
Hong Kong, Hong Kong SAR, Hong Kong, 00000
- Prince of Wales Hospital
-
Hong Kong, Hong Kong SAR, Hong Kong, 00000
- Princess Margaret Hospital
-
Hong Kong, Hong Kong SAR, Hong Kong, 00000
- Queen Mary Hospital
-
-
-
-
Gujarat
-
Ahmedabad, Gujarat, Indien, 380052
- Mavani Research Center
-
Ahmedabad, Gujarat, Indien, 380054
- Shalby Hospital
-
-
Kerala
-
Thiruvananthapuram, Kerala, Indien, 695011
- Government Medical College Thiruvananthapuram
-
-
Maharashtra
-
Hadapsar, Maharashtra, Indien, 411013
- Noble Hospital
-
Mumbai, Maharashtra, Indien, 400016
- P. D. Hinduja Hospital and Medical Research Centre
-
Nashik, Maharashtra, Indien, 422002
- Shree Siddhivinayak Maternity & Nursing Home
-
-
National Capital Territory of Delhi
-
New Delhi, National Capital Territory of Delhi, Indien, 110017
- Max Super Speciality Hospital, Saket
-
-
Odisha
-
Bhubaneswar, Odisha, Indien, 751019
- All India Institute of Medical Sciences
-
-
Tamil Nadu
-
Chennai, Tamil Nadu, Indien, 600003
- Madras Medical College
-
-
Telangana
-
Telangana, Telangana, Indien, 500012
- Osmania General Hospital
-
-
West Bengal
-
Kolkata, West Bengal, Indien, 700020
- Institute of Post-Graduate Medical Education and Research
-
-
-
-
-
Ashdod, Israel, 7747629
- Assuta Ashdod Public Hospital (R.A)
-
Ashkelon, Israel, 7830604
- Barzilai Medical Center | Department of Nephrology and Hypertension
-
Beersheba, Israel, 8410101
- Clalit Health | Soroka Medical Center - Internal Medicine Department
-
Haifa, Israel, 3109601
- Rambam Health Corporation
-
Kfar Saba, Israel, 4428164
- Meir Medical Center
-
Nahariya, Israel, 2210001
- Health Corporation of Galilee Medical Center
-
Petah Tikva, Israel, 4941492
- Rabin Medical Center | Beilinson Hospital - Internal Medicine C Department
-
Ramat Gan, Israel, 5262000
- Chaim Sheba Medical Center
-
Rehovot, Israel, 7610001
- Kaplan Medical Center
-
Tel Aviv, Israel, 6423906
- Tel-Aviv Sourasky Medical Center
-
Tiberias, Israel, 1528001
- Poria Medical Center | Nephrology and Hypertension Department
-
Ẕerifin, Israel, 7030000
- Shamir Medical Center (Assaf Harofeh)
-
-
-
-
Campania
-
Napoli, Campania, Italien, 80131
- A.O.U. Universita' Degli Studi Della Campania Luigi Vanvitelli - Nefrologia
-
-
Emilia-Romagna
-
Bologna, Emilia-Romagna, Italien, 40138
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Nefrologia, Dialisi e Trapianto
-
Modena, Emilia-Romagna, Italien, 41124
- Azienda Ospedaliero Universitaria di Modena_Policlinico - Nefrologia, Dialisi e Trapianto di Rene
-
Parma, Emilia-Romagna, Italien, 43126
- Azienda Ospedaliero Universitaria Parma - SC Nefrologia
-
Reggio Emilia, Emilia-Romagna, Italien, 42123
- Azienda USL IRCCS di Reggio Emilia_Arcispedale Santa Maria Nuova - S.C. Nefrologia e Dialisi
-
-
Lazio
-
Rome, Lazio, Italien, 00168
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Nefrologia
-
-
Lombardy
-
Desio, Lombardy, Italien, 20832
- Azienda Socio Sanitaria Territoriale Della Brianza_Ospedale Pio XI - Nefrologia e Dialisi
-
Legnano, Lombardy, Italien, 20025
- Azienda Socio Sanitaria Territoriale Ovest Milanese_Legnano - Nefrologia e Dialisi
-
Pavia, Lombardy, Italien, 27100
- Istituti Clinici Scientifici Maugeri S.p.A._Pavia - Nefrologia
-
Ranica, Lombardy, Italien, 24020
- Istituto Ricerche Farmacologiche Mario Negri - Unità Operativa Complessa Malattie Renali
-
Rho, Lombardy, Italien, 20017
- Azienda Socio Sanitaria Territoriale Rhodense
-
-
Sicily
-
Catania, Sicily, Italien, 95126
- Azienda Ospedaliera Per L'Emergenza Cannizzaro - Nefrologia e Dialisi
-
-
-
-
-
Fukuoka, Japan, 814-0180
- Fukuoka University Hospital
-
Fukuoka, Japan, 811-0213
- Social Medical Corporation The Chiyukai Foundation Fukuoka Wajiro Hospital
-
Kumamoto, Japan, 861-8520
- Japanese Red Cross Kumamoto Hospital
-
Nara, Japan, 630-8581
- Nara Prefecture General Medical Center
-
Saga, Japan, 840-8571
- Saga-Ken Medical Centre Koseikan
-
Saitama, Japan, 330-8553
- Japanese Red Cross Saitama Hospital
-
-
Aichi-ken
-
Nagoya, Aichi-ken, Japan, 455-8530
- Chubu Rosai Hospital
-
Nagoya, Aichi-ken, Japan, 467-8602
- Nagoya City University Hospital
-
Nagoya, Aichi-ken, Japan, 457-8511
- Daido Clinic
-
Yatomi, Aichi-ken, Japan, 498-8502
- Kainan Hospital
-
-
Chiba
-
Urayasu, Chiba, Japan, 279-0021
- Juntendo University Urayasu Hospital
-
-
Fukuoka
-
Iizuka, Fukuoka, Japan, 820-8505
- Aso Iizuka Hospital
-
Kitakyushu, Fukuoka, Japan, 802-8555
- Kokura Memorial Hospital
-
Kitakyushu, Fukuoka, Japan, 806-8501
- JCHO Kyushu Hospital
-
-
Gifu
-
Minokamo, Gifu, Japan, 505-8510
- Central Japan International Medical Center
-
-
Hyōgo
-
Kobe, Hyōgo, Japan, 650-0017
- Kobe University Hospital
-
Nishinomiya, Hyōgo, Japan, 662-0918
- Hyogo Prefectural Nishinomiya Hospital
-
-
Ibaraki
-
Toride, Ibaraki, Japan, 302-0022
- JA Toride Medical Center
-
Tsuchiura, Ibaraki, Japan, 300-0028
- Tsuchiura Kyodo General Hospital
-
-
Ishikawa-ken
-
Kanazawa, Ishikawa-ken, Japan, 920-8650
- National Hospital Organization Kanazawa Medical Center | Clinical Trial Management Office
-
Kanazawa, Ishikawa-ken, Japan, 920-8641
- Kanazawa University Hospital
-
-
Iwate
-
Morioka, Iwate, Japan, 020-0066
- Iwate Prefectural Central Hospital
-
-
Kanagawa
-
Hiratsuka, Kanagawa, Japan, 254-8502
- Hiratsuka Kyosai Hospital
-
Isehara, Kanagawa, Japan, 259-1193
- Tokai University Hospital
-
Kawasaki, Kanagawa, Japan, 216-8511
- St. Marianna University Hospital
-
Yokohama, Kanagawa, Japan, 236-0004
- Yokohama City University Hospital
-
Yokohama, Kanagawa, Japan, 247-8581
- Yokohama Sakae Kyosai Hospital
-
Yokohama, Kanagawa, Japan, 234-0054
- Saiseikai Yokohamashi Nanbu Hospital
-
-
Nagano
-
Matsumoto, Nagano, Japan, 390-8621
- Shinshu University Hospital
-
Matsumoto, Nagano, Japan, 390-1401
- Matsumoto City Hospital
-
-
Okayama-ken
-
Kurashiki, Okayama-ken, Japan, 701-0192
- Kawasaki Medical School Hospital
-
-
Osaka
-
Sakai, Osaka, Japan, 591-8025
- Osaka Rosai Hospital
-
-
Saitama
-
Irima-gun, Saitama, Japan, 350-0495
- Saitama Medical University Hospital
-
Koshigaya, Saitama, Japan, 343-8577
- Koshigaya Municipal Hospital
-
-
Shizuoka
-
Hamamatsu, Shizuoka, Japan, 430-8558
- Seirei Hamamatsu General Hospital
-
-
Tokyo
-
Bunkyo-ku, Tokyo, Japan, 113-8431
- Juntendo University Hospital
-
Bunkyo-ku, Tokyo, Japan, 113-8655
- The University of Tokyo Hospital
-
Fuchū, Tokyo, Japan, 183-8524
- Tokyo Metropolitan Tama Medical Center
-
Itabashi-ku, Tokyo, Japan, 173-8610
- Nihon University Itabashi Hospital
-
Shinjuku-ku, Tokyo, Japan, 160-0023
- Tokyo Medical University Hospital
-
-
Yamanashi
-
Chūō, Yamanashi, Japan, 409-3898
- University of Yamanashi Hospital
-
-
-
-
-
Beijing, Kina, 100853
- Chinese PLA General Hospital
-
Beijing, Kina, 100029
- Beijing Anzhen Hospital, Capital Medical University
-
Beijing, Kina, 100029
- China-Japan Friendship Hospital
-
Beijing, Kina, 102218
- Beijing Tsinghua Changgung Hospital
-
Chongqing, Kina, 400042
- Daping Hospital, 3rd Affil Hosp. 3rd Military Med Univ PLA
-
Shanghai, Kina, 200092
- Xinhua Hos Affiliated to SH Jiaotong Uni School of Medicine
-
Shanghai, Kina, 200240
- Shanghai Fifth People's Hospital,Fudan University
-
Shanghai, Kina, 201199
- Central Hospital of Minhang District, Shanghai
-
Shanghai, Kina, 200032
- Zhongshan Hospital, Fudan University - Oncology Department
-
Tianjin, Kina, 300121
- Tianjin Union Medicine Centre (People's Hospital of Tianjin)
-
-
Anhui
-
Bengbu, Anhui, Kina, MISSING
- The First Affiliated Hospital of Bengbu Medical College
-
Hefei, Anhui, Kina, 230601
- The Second Hospital of Anhui Medical University
-
-
Fujian
-
Xiamen, Fujian, Kina, 361003
- The First Affiliated Hospital of Xiamen University
-
-
Gansu
-
Lanzhou, Gansu, Kina, 730030
- Lanzhou University Second Hospital
-
-
Guangdong
-
Guangzhou, Guangdong, Kina, 510405
- The First Affiliated Hospital of Guangzhou University of TCM
-
Guangzhou, Guangdong, Kina, 510630
- The First Affiliated Hospital of Jinan University
-
Guangzhou, Guangdong, Kina, 510280
- Zhujiang Hospital of Southern Medical University
-
Huizhou, Guangdong, Kina, 516001
- Huizhou Central People's Hospital
-
Jiangmen, Guangdong, Kina, 529099
- Jiangmen Wuyi Hospital of Traditional Chinese Medicine
-
-
Guangxi
-
Liuchow, Guangxi, Kina, 545005
- Liuzhou Worker's Hospital
-
Liuchow, Guangxi, Kina, 545006
- People's Hospital of Liuzhou City
-
Nanning, Guangxi, Kina, 530021
- The People's Hospital Of Guangxi Zhuang Autonomous Region
-
-
Guizhou
-
Guiyang, Guizhou, Kina, 550004
- The Affiliated Hospital of Guizhou Medical University
-
-
Hebei
-
Zhangjiakou, Hebei, Kina, 075000
- The First Affiliated Hospital of Hebei North University
-
-
Hubei
-
Wuhan, Hubei, Kina, 430022
- Wuhan Hospital Of Traditional Chinese And Western Medicine
-
Wuhan, Hubei, Kina, 430034
- Puai Hospital,Tongji Medical College, Huazhong Univ Sci&Tech
-
Wuhan, Hubei, Kina, 430040
- Renmin Hosp., Wuhan Univ.
-
-
Inner Mongolia
-
Baotou, Inner Mongolia, Kina, 14010
- The First Affiliated Hospital of Baotou Medical College
-
-
Jiangsu
-
Changzhou, Jiangsu, Kina, 213003
- 1st Peopl's Hosp of Changzhou 3rd Affil Hosp of Soochow Univ
-
Huai'an, Jiangsu, Kina, 223300
- Huai'an First People's Hospital, Nanjing Medical University
-
Nanjing, Jiangsu, Kina, 210009
- Zhongda Hospital Southeast University
-
Nanjing, Jiangsu, Kina, 210029
- Jiangsu Province Hospital of Chinese Medicine
-
-
Jiangxi
-
Nanchang, Jiangxi, Kina, 330006
- The First Affiliated Hospital of Nanchang University
-
Pingxiang, Jiangxi, Kina, 337055
- Jiangxi Pingxiang People's Hospital
-
-
Jilin
-
Changchun, Jilin, Kina, 130000
- The Second Hospital of Jilin University
-
Siping, Jilin, Kina, MISSING
- Siping Central Hospital
-
-
Liaoning
-
Dalian, Liaoning, Kina, 116011
- The First Affiliated Hospital of Dalian Medical University
-
-
Ningxia
-
Yinchuan, Ningxia, Kina, 750004
- General Hospital of Ningxia Medical University
-
-
Shandong
-
Jinan, Shandong, Kina, 250000
- Qilu Hosp., Shandong Univ.
-
-
Shanxi
-
Xi’an, Shanxi, Kina, 710061
- The First Affiliated Hospital of Xi'an Jiaotong University
-
-
Sichuan
-
Chengdu, Sichuan, Kina, 610072
- SichuanAcademyofMedicalSciences&SichuanProvincialPeople'sHos
-
Chengdu, Sichuan, Kina, MISSING
- Sichuan University West China Hospital
-
-
Xinjiang
-
Ürümqi, Xinjiang, Kina, 830011
- The First Affiliated Hospital of Xinjiang Medical University
-
-
Zhejiang
-
Ningbo, Zhejiang, Kina, 31510
- Hwa Mei Hospital, University of Chinese Academy Sciences
-
Wenzhou, Zhejiang, Kina, 325000
- The First Affiliated Hospital of Wenzhou Medical Univ (New)
-
-
-
-
-
Kedah, Malaysia, 8000
- Hospital Sultan Abdul Halim
-
Kuala Lumpur, Malaysia, 50586
- Hospital Kuala Lumpur
-
Kuala Lumpur, Malaysia, 59100
- Universiti Malaya Medical Centre
-
Kuala Pahang, Malaysia, 25100
- Hospital Tengku Ampuan Afzan
-
Kuala Selangor, Malaysia, 43000
- Hospital Kajang
-
Muar town, Malaysia, 84000
- Hospital Pakar Sultanah Fatimah
-
Negeri Sembilan, Malaysia, 70300
- Hospital Tuanku Jaafar | Nephrology Department
-
Perak, Malaysia, 30450
- Hospital Raja Permaisuri Bainun
-
Perak, Malaysia, 32040
- Hospital Seri Manjung
-
Pulau Pinang, Malaysia, 10450
- Hospital Pulau Pinang
-
-
Selangor
-
Shah Alam, Selangor, Malaysia, 68100
- Hospital Selayang
-
-
-
-
-
Aguascalientes, Mexico, 20124
- Sitio Alfredo Chew Wong | Aguascalientes, Mexico
-
-
Aguascalientes
-
Missing, Aguascalientes, Mexico, 20230
- Fundacion Cardiovascular de Aguascalientes | Aguascalientes, Mexico
-
-
Sinaloa
-
Culiacán, Sinaloa, Mexico, 80230
- SINACOR | Culiacan, Mexico
-
-
Veracruz
-
Puerto de Veracruz, Veracruz, Mexico, 91900
- Sociedad de Metabolismo y Corazon S.C. | Veracruz, Mexico
-
-
-
-
-
Leiria, Portugal, 2410-197
- Centro Hospitalar de Leiria | Santo Andre Hospital - Research Center
-
Lisbon, Portugal, 1069-166
- Centro Hospitalar Universitario de Lisboa Central | Hospital Curry Cabral - Nephrology Department
-
-
Lisbon District
-
Carnaxide, Lisbon District, Portugal, 2790-134
- Unidade Local De Saúde De Lisboa Ocidental E.P.E.
-
-
Santarém District
-
Torres Novas, Santarém District, Portugal, 2350-754
- Centro Hospitalar do Medio Tejo | Unidade de Torres Novas - Nephrology Department
-
-
Setúbal District
-
Almada, Setúbal District, Portugal, 2805-267
- Unidade Local de Saude Almada-Seixal | Hospital Garcia de Orta - Research Department
-
-
-
-
-
Arkhangelsk, Rusland, 163001
- First City Clinical Hospital n.a. E.E. Volosevich
-
Izhevsk, Rusland, 426063
- Izhevsk City Clinical Hospital #9
-
Kemerovo, Rusland, 650066
- Kemerovo Regional Clinical Hospital
-
Moscow, Rusland, 117292
- City clinical hospital n.a. V.V. Vinogradov
-
Moscow, Rusland, 123182
- City Hospital #52
-
Omsk, Rusland, 644112
- City Clinical Hospital of Emergency Care #1
-
Rostov-on-Don, Rusland, 344022
- Rostov State Medical University
-
Saint Petersburg, Rusland, 197082
- Limited liability company "MK-Med"
-
Saratov, Rusland, 410030
- Saratov City Clinical Hospital #9
-
Sestroretsk, Rusland, 197706
- City clinical hospital #40 Sestroretsk
-
Voronezh, Rusland, 394018
- Voronezh Regional Clinical Consultancy-Diagnostic Center
-
Yaroslavl, Rusland, 150062
- Regional Clinical Hospital Yaroslavl
-
-
-
-
-
Singapore, Singapore, 169608
- Singapore General Hospital
-
Singapore, Singapore, 308433
- Tan Tock Seng Hospital
-
Singapore, Singapore, 768828
- Khoo Teck Puat Hospital
-
Singapore, Singapore, 519457
- SingHealth Polyclinics - Pasir Ris
-
Singapore, Singapore, 119074
- National University Hospital Medical Centre
-
-
-
-
-
Barcelona, Spanien, 08003
- Hospital del Mar | Nephrology Department
-
Barcelona, Spanien, 08035
- Hospital Universitari Vall D Hebron | Nefrologia
-
Madrid, Spanien, 28034
- Hospital Universitario Ramon Y Cajal | Medicina Interna
-
Madrid, Spanien, 28041
- Hospital Universitario 12 De Octubre | Nefrologia
-
Valencia, Spanien, 46010
- Hospital Clinico Universitario De Valencia | Nefrologia
-
Valencia, Spanien, 46017
- Hospital Universitario Dr Peset Aleixandre | Nefrologia
-
Valencia, Spanien, 46026
- Hospital Universitario Y Politecnico La Fe | Nefrologia
-
-
A Coruña
-
Ferrol, A Coruña, Spanien, 15405
- Area Sanitaria De Ferrol | Medicina Interna
-
-
Barcelona
-
L'Hospitalet de Llobregat, Barcelona, Spanien, 8907
- Bellvitge Hospital Universitari | Nefrologia
-
-
Lugo
-
Burela de Cabo, Lugo, Spanien, 27880
- Hospital Publico Da Marina | Nefrologia
-
-
Madrid
-
Alcalá de Henares, Madrid, Spanien, 28805
- Hospital Universitario Central De Asturias | Nefrologia
-
-
-
-
-
Busan, Sydkorea, 47392
- Inje University Busan Paik Hospital
-
Daejeon, Sydkorea, 35015
- Chung Nam National University Hospital
-
Gyeonggi-do, Sydkorea, 425-707
- Ansan Hospital | Nephrology
-
Seoul, Sydkorea, 5278
- Kyung Hee University Hospital at Gangdong
-
Seoul, Sydkorea, 7061
- Seoul National University Boramae Medical Center
-
Seoul, Sydkorea, 7441
- KangNam Sacred Heart Hospital
-
Seoul, Sydkorea, 06351
- Samsung Medical Center - Cardiology
-
-
Gang''weondo
-
Wŏnju, Gang''weondo, Sydkorea, 26426
- Yonsei University Wonju Christian Hospital
-
-
Gyeonggido
-
Anyang-si, Gyeonggido, Sydkorea, 14068
- Hallym University Sacred Heart Hospital
-
Goyang-si, Gyeonggido, Sydkorea, 411-706
- Inje University Ilsan Paik Hospital
-
Goyang-si, Gyeonggido, Sydkorea, 10326
- Dongguk University Ilsan Hospital
-
Seongnam-si, Gyeonggido, Sydkorea, 13496
- CHA Bundang Medical Center | Nephrology
-
-
Incheon Gwang''yeogsi
-
Incheon, Incheon Gwang''yeogsi, Sydkorea, 21431
- The Catholic University of Korea, Incheon St.Mary's Hospital
-
-
Seoul
-
Teugbyeolsi, Seoul, Sydkorea, 134-701
- Kangdong Sacred Heart Hospital
-
-
Seoul Teugbyeolsi
-
Seoul, Seoul Teugbyeolsi, Sydkorea, 3080
- Seoul National University Hospital
-
Seoul, Seoul Teugbyeolsi, Sydkorea, 03312
- The Catholic Univ. of Korea Eunpyeong St. Mary's Hospital
-
Seoul, Seoul Teugbyeolsi, Sydkorea, 03722
- Severance Hospital, Yonsei University Health System - Cardiology
-
-
-
-
-
Changhua, Taiwan, 50006
- Changhua Christian Hospital
-
Kaohsiung City, Taiwan, 833
- Chang Gung Memorial Hospital Kaohsiung
-
Taichung, Taiwan, 40705
- Taichung Veterans General Hospital
-
Taichung, Taiwan, 404327
- China Medical University Hospital
-
Taipei, Taiwan, 100
- National Taiwan University Hospital
-
Taipei, Taiwan, 110
- Taipei Medical University | Clinical Research Center
-
Taoyuan District, Taiwan, 33305
- Chang Gung Memorial Hospital at Linkou
-
-
Hsinchu
-
Taoyuan District, Hsinchu, Taiwan, 300
- National Taiwan University Hospital, Hsin-Chu Branch
-
-
Taipei
-
New Taipei City, Taipei, Taiwan, 220
- Far Eastern Memorial Hospital | Nephrology Department
-
-
-
-
-
Frýdek-Místek, Tjekkiet, 738 01
- MUDr.Petr Bucek s.r.o.
-
Hodonín, Tjekkiet, 695 01
- CTC Hodonín, s.r.o.
-
Ostrava, Tjekkiet, 708 52
- Fakultni nemocnice Ostrava
-
Pilsen, Tjekkiet, 323 33
- Privamed s.r.o.
-
Prague, Tjekkiet, 12808
- Vseobecna fakultni nemocnice v Praze
-
Prague, Tjekkiet, 140 00
- Nefrologicka ambulance
-
Prague, Tjekkiet, 160 00
- Nefromed s.r.o.
-
Rychnov nad Kněžnou, Tjekkiet, 516 01
- Vestra Clinics s.r.o.
-
Znojmo, Tjekkiet, 669 02
- Nemocnice Znojmo
-
-
South Moravian
-
Brno, South Moravian, Tjekkiet, 625 00
- Fakultní nemocnice Brno - Interní gastroenterologická klinika
-
-
-
-
-
Budapest, Ungarn, 1097
- Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet
-
Kaposvár, Ungarn, 7400
- Somogy Varmegyei Kaposi Mor Oktato Korhaz
-
Kistarcsa, Ungarn, 2143
- Kistarcsai Flor Ferenc Korhaz
-
Nagykanizsa, Ungarn, 8800
- Nagykanizsai Kanizsai Dorottya Korhaz
-
Nyíregyháza, Ungarn, 4400
- Medifarma-98 Egeszsegugyi, Kereskedelmi es Szolgaltato Kft.
-
Pécs, Ungarn, 7624
- Pécsi Tudományegyetem Klinikai Központ
-
Szombathely, Ungarn, 9700
- Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
En klinisk diagnose af kronisk nyresygdom og:
- Urin albumin/kreatinin ratio (UACR) på ≥ 200 men ≤ 3500 mg/g og estimeret glomerulær filtrationshastighed (eGFR) ≥ 25 men < 90 ml/min/1,73 m^2 ved screening, og
- Dokumentation af albuminuri/proteinuri i deltagerens journal mindst 3 måneder før screening.
- Stabil og maksimalt tolereret mærket dosis af en angiotensin-konverterende enzymhæmmer (ACEI) eller angiotensinreceptorblokker (ARB) i mindst 4 uger før screening
- K+ ≤ 4,8 mmol/L ved screening
Ekskluderingskriterier:
- Etableret diagnose af type 1 eller 2 diabetes mellitus eller HbA1c ≥ 6,5 % (48 mmol/mol)
- Autosomal dominant eller autosomal recessiv polycystisk nyresygdom
- Lupus nefritis eller anti-neutrofilt cytoplasmatisk autoantistof (ANCA)-associeret vaskulitis eller enhver anden primær eller sekundær nyresygdom, der kræver immunsuppressiv behandling inden for 6 måneder før screening
- Symptomatisk hjertesvigt med reduceret ejektionsfraktion med klasse 1A indikation for Mineralocorticoid receptor antagonister (MRA)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: Placebo
Deltagerne vil modtage placebo.
|
Tablet, én gang dagligt, oralt
|
|
Eksperimentel: Finerenone (BAY94-8862)
Deltagerne vil modtage finerenone.
|
Tablet, 10 mg eller 20 mg, én gang dagligt (OD), oral
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Gennemsnitlig ændringshastighed målt ved den totale hældning af eGFR fra baseline til måned-32.
Tidsramme: Fra baseline til måned 32
|
eGFR: Estimeret glomerulær filtrationshastighed
|
Fra baseline til måned 32
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Tid til sammensætningen af nyresvigt, vedvarende eGFR-fald på >= 57 %, indlæggelse af hjertesvigt eller kardiovaskulær (CV) død
Tidsramme: Op til slutningen af studiebesøget (op til ca. 49 måneder)
|
Op til slutningen af studiebesøget (op til ca. 49 måneder)
|
|
Tid til sammensætningen af nyresvigt eller vedvarende eGFR-fald på >= 57 %
Tidsramme: Op til slutningen af studiebesøget (op til ca. 49 måneder)
|
Op til slutningen af studiebesøget (op til ca. 49 måneder)
|
|
Tid til det sammensatte til hjertesvigt hospitalsindlæggelse eller CV død
Tidsramme: Op til slutningen af studiebesøget (op til ca. 49 måneder)
|
Op til slutningen af studiebesøget (op til ca. 49 måneder)
|
|
Antal deltagere med Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Adverse Events (TESAEs) og Adverse events of special interest (AESI)
Tidsramme: Op til cirka 50 måneder
|
Op til cirka 50 måneder
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
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.
- Ostrominski JW, Filippatos G, Claggett BL, Miao ZM, Desai AS, Jhund PS, Henderson A, Rohwedder K, Brinker MD, Scalise A, Schloemer P, Lam CSP, Senni M, Shah SJ, Voors AA, Zannad F, Rossing P, Ruilope LM, Anker SD, Pitt B, Agarwal R, McMurray JJV, Solomon SD, Vaduganathan M. Effect of Finerenone on Morbidity and Mortality in CKD. J Am Soc Nephrol. 2025 Sep 12. doi: 10.1681/ASN.0000000823. Online ahead of print. No abstract available.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Patologiske processer
- Mandlige urogenitale sygdomme
- Urologiske sygdomme
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Kronisk sygdom
- Sygdomsegenskaber
- Nyreinsufficiens
- Nyresygdomme
- Nyreinsufficiens, kronisk
- Substandard medicin
- Farmaceutiske præparater
- finereonon
Andre undersøgelses-id-numre
- 21177
- 2021-000421-27 (EudraCT nummer)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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 .
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