- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05047263
A Trial to Learn How Well Finerenone Works and How Safe it is in Adult Participants With Non-diabetic Chronic Kidney Disease (FIND-CKD)
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Phase 3 Study to Investigate the Efficacy and Safety of FInerenone, in Addition to Standard of Care, on the Progression of Kidney Disease in Patients With Non-Diabetic Chronic Kidney Disease
Researchers are looking for a better way to treat people who have non-diabetic chronic kidney disease (non-diabetic CKD). The trial treatment, finerenone, is being developed to help people who have long lasting kidney disease, also known as chronic kidney disease (CKD). It works by blocking a certain hormone called aldosterone that causes injury and inflammation in the heart and kidney which is known to play a role in CKD.
In this trial, the researchers want to learn if finerenone helps to slow down the worsening of the participants' non-diabetic CKD compared to a placebo. A placebo looks like a trial treatment but does not have any medicine in it. The trial will include about 1,580 men and women who are at least 18 years old.
The participants will take finerenone or a placebo once a day as tablets by mouth. All of the participants will also continue to take their current medicine for their CKD. The participants will be in the trial for up to about 50 months.
During the trial, the doctors will collect blood and urine samples and check the participants' health. The participants will also answer questions about how they are feeling and what adverse events they are having. An adverse event is a medical problem that happens during the trial. Doctors keep track of all adverse events that happen in trials, even if they do not think the adverse events might be related to the trial treatments.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Buenos Aires, Argentina, C1061AAS
- Centro de Investigación y Prevención Cardiovascular
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Córdoba, Argentina, X5016KET
- Clinica Privada Velez Sarsfield
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Santa Fe, Argentina, 3000
- Clinica de Nefrologia Urologia y Enfermedades Cardiovascular
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Santa Fe, Argentina, S3000FWO
- Centro de Investigaciones Clinicas del Litoral | Santa Fe, Argentina
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Buenos Aires
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Berazategui, Buenos Aires, Argentina, B1837
- Asociacion de Fomento y Sala de Primeros Auxilios Alberto Mignaburu | Berazategui, Argentina
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Ciudad Autónoma de Buenos Aire, Buenos Aires, Argentina, C1056ABI
- Centro de Investigaciones Metabolicas | Ciudad de Autonoma de Buenos Aires, Argentina
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Lanús, Buenos Aires, Argentina, B1824
- Centro de Investigaciones Medicas Lanus | Buenos Aires, Argentina
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Mar del Plata, Buenos Aires, Argentina, B7600FZ0
- Instituto de Investigaciones Clinicas de Mar del Plata | Mar del Plata, Argentina
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Ciudad Auton. de Buenos Aires
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CABA, Ciudad Auton. de Buenos Aires, Argentina, C1018DES
- CEDIC Centro de Investigación Clínica | Buenos Aires, Argentina
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San Luis Province
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San Luis, San Luis Province, Argentina, D5700CGR
- Centro de Rehabilitacion Cardiovascular | San Luis, Argentina
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New South Wales
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Concord, New South Wales, Australia, 2139
- Concord Repatriation General Hospital
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Kogarah, New South Wales, Australia, 2217
- St George Hospital
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Wollongong, New South Wales, Australia, 2500
- Illawarra Shoalhaven Local Health District
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Queensland
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Birtinya, Queensland, Australia, 4575
- Sunshine Coast University Hospital
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Woolloongabba, Queensland, Australia, 4102
- Princess Alexandra Hospital Australia
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Victoria
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Box Hill, Victoria, Australia, 3128
- Eastern Health Integrated Renal Service
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Reservoir, Victoria, Australia, 3073
- Melbourne Renal Research Group
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St Albans, Victoria, Australia, 3021
- Sunshine Hospital
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Bruxelles - Brussel, Belgium, 1200
- CU Saint-Luc/UZ St-Luc
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Ghent, Belgium, 9000
- UZ Gent
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Leuven, Belgium, 3000
- UZ Leuven Gasthuisberg
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Liège, Belgium, 4000
- CHU de Liege
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Roeselare, Belgium, 8800
- AZ Delta / Nephrology
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West-Vlaanderen
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Kortrijk, West-Vlaanderen, Belgium, 8500
- AZ Groeninge Campus Kennedylaan | Nephrology
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Burgas Province
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Burgas, Burgas Province, Bulgaria, 8000
- Medical Center ''4Life''
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Dobrich Province
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Dobrich, Dobrich Province, Bulgaria, 9300
- Viva Phoenix Medical Center | Clinical Trials Department
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Montana Province
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Montana, Montana Province, Bulgaria, 3400
- Medical Center Hera | Montana Branch
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Pernik Province
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Pernik, Pernik Province, Bulgaria, 2300
- Multiprofile Hospital for Active Treatment Sveti Georgi OOD, Pernik - Department of Cardiology
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Sofia City Province
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Sofia, Sofia City Province, Bulgaria, 1618
- Diagnostic-Consultative Center XX | Nephrology Department
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Stara Zagora Province
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Stara Zagora, Stara Zagora Province, Bulgaria, 6010
- Medical Center Zara-Med EOOD | Nephrology Department
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Veliko Tarnovo Province
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Gorna Oryahovitsa, Veliko Tarnovo Province, Bulgaria, 5100
- Multiprofile Hospital for Active Treatment St. Ivan Rilski - Gorna Oryahovitsa | Nephrology Department
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Veliko Tarnovo, Veliko Tarnovo Province, Bulgaria, 5600
- Medical Center ''Nevromedics''
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Beijing, China, 100853
- Chinese PLA General Hospital
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Beijing, China, 100029
- Beijing Anzhen Hospital, Capital Medical University
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Beijing, China, 100029
- China-Japan Friendship Hospital
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Beijing, China, 102218
- Beijing Tsinghua Changgung Hospital
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Chongqing, China, 400042
- Daping Hospital, 3rd Affil Hosp. 3rd Military Med Univ PLA
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Shanghai, China, 200092
- Xinhua Hos Affiliated to SH Jiaotong Uni School of Medicine
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Shanghai, China, 200240
- Shanghai Fifth People's Hospital,Fudan University
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Shanghai, China, 201199
- Central Hospital of Minhang District, Shanghai
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Shanghai, China, 200032
- Zhongshan Hospital, Fudan University - Oncology Department
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Tianjin, China, 300121
- Tianjin Union Medicine Centre (People's Hospital of Tianjin)
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Anhui
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Bengbu, Anhui, China, MISSING
- The First Affiliated Hospital Of Bengbu Medical College
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Hefei, Anhui, China, 230601
- The Second Hospital of Anhui Medical University
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Fujian
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Xiamen, Fujian, China, 361003
- The First Affiliated Hospital of Xiamen University
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Gansu
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Lanzhou, Gansu, China, 730030
- Lanzhou University Second Hospital
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Guangdong
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Guangzhou, Guangdong, China, 510405
- The First Affiliated Hospital of Guangzhou University of TCM
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Guangzhou, Guangdong, China, 510630
- The First Affiliated Hospital of Jinan University
-
Guangzhou, Guangdong, China, 510280
- ZhuJiang Hospital of Southern Medical University
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Huizhou, Guangdong, China, 516001
- Huizhou Central People's Hospital
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Jiangmen, Guangdong, China, 529099
- Jiangmen Wuyi Hospital of Traditional Chinese Medicine
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Guangxi
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Liuchow, Guangxi, China, 545005
- Liuzhou Worker's Hospital
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Liuchow, Guangxi, China, 545006
- People's Hospital of Liuzhou City
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Nanning, Guangxi, China, 530021
- The People's Hospital Of Guangxi Zhuang Autonomous Region
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Guizhou
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Guiyang, Guizhou, China, 550004
- The Affiliated Hospital of Guizhou Medical University
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Hebei
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Zhangjiakou, Hebei, China, 075000
- The First Affiliated Hospital of Hebei North University
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Hubei
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Wuhan, Hubei, China, 430022
- Wuhan Hospital Of Traditional Chinese And Western Medicine
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Wuhan, Hubei, China, 430034
- Puai Hospital,Tongji Medical College, Huazhong Univ Sci&Tech
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Wuhan, Hubei, China, 430040
- Renmin Hosp., Wuhan Univ.
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Inner Mongolia
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Baotou, Inner Mongolia, China, 14010
- The First Affiliated Hospital of Baotou Medical College
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Jiangsu
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Changzhou, Jiangsu, China, 213003
- 1st Peopl's Hosp of Changzhou 3rd Affil Hosp of Soochow Univ
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Huai'an, Jiangsu, China, 223300
- Huai'an First People's Hospital, Nanjing Medical University
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Nanjing, Jiangsu, China, 210009
- Zhongda Hospital Southeast University
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Nanjing, Jiangsu, China, 210029
- Jiangsu Province Hospital of Chinese Medicine
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Jiangxi
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Nanchang, Jiangxi, China, 330006
- The First Affiliated Hospital of Nanchang University
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Pingxiang, Jiangxi, China, 337055
- Jiangxi Pingxiang People's Hospital
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Jilin
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Changchun, Jilin, China, 130000
- The Second Hospital of Jilin University
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Siping, Jilin, China, MISSING
- Siping Central Hospital
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Liaoning
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Dalian, Liaoning, China, 116011
- The First Affiliated Hospital of Dalian Medical University
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Ningxia
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Yinchuan, Ningxia, China, 750004
- General Hospital of Ningxia Medical University
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Shandong
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Jinan, Shandong, China, 250000
- Qilu Hosp., Shandong Univ.
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Shanxi
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Xi’an, Shanxi, China, 710061
- The First Affiliated Hospital of Xi'an Jiaotong University
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Sichuan
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Chengdu, Sichuan, China, 610072
- SichuanAcademyofMedicalSciences&SichuanProvincialPeople'sHos
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Chengdu, Sichuan, China, MISSING
- Sichuan University West China Hospital
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Xinjiang
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Ürümqi, Xinjiang, China, 830011
- The First Affiliated Hospital of Xinjiang Medical University
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Zhejiang
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Ningbo, Zhejiang, China, 31510
- Hwa Mei Hospital, University of Chinese Academy Sciences
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Wenzhou, Zhejiang, China, 325000
- The First Affiliated Hospital of Wenzhou Medical Univ (New)
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Frýdek-Místek, Czechia, 738 01
- MUDr.Petr Bucek s.r.o.
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Hodonín, Czechia, 695 01
- CTC Hodonín, s.r.o.
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Ostrava, Czechia, 708 52
- Fakultni nemocnice Ostrava
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Pilsen, Czechia, 323 33
- Privamed s.r.o.
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Prague, Czechia, 12808
- Vseobecna fakultni nemocnice v Praze
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Prague, Czechia, 140 00
- Nefrologicka ambulance
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Prague, Czechia, 160 00
- Nefromed s.r.o.
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Rychnov nad Kněžnou, Czechia, 516 01
- Vestra Clinics s.r.o.
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Znojmo, Czechia, 669 02
- Nemocnice Znojmo
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South Moravian
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Brno, South Moravian, Czechia, 625 00
- Fakultní nemocnice Brno - Interní gastroenterologická klinika
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Copenhagen, Denmark, 2100
- Rigshospitalet, Copenhagen University Hospital | Department of Nefrology
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Esbjerg, Denmark, 6700
- Hospital of South West Jutland | Department of Endocrinology Research
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Herlev, Denmark, 2730
- Herlev Hospital | Nephrology Department
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Herning, Denmark, DK-7400
- Region Midtjylland | Regionshospitalet Godstrup - Nephrology Department
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Holbæk, Denmark, 4300
- Region Sjælland | Holbaek Sygehus - Cardiology department
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Odense C, Denmark, 5000
- Odense University Hospital | Department of Kidney Medicine
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Arta, Greece, 47132
- General Hospital of Arta | Nephrology Department
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Athens, Greece, 11527
- General Hospital of Athens Laiko
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Athens, Greece, 11527
- Hippokration General Hospital of Athens
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Heraklion, Greece, 71500
- University General Hospital of Heraklion-Nephrology Clinic
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Ioannina, Greece, 45500
- University General Hospital Of Ioannina-Nephrology Clinic
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Thessaloniki, Greece, 54642
- Ippokratio General Hospital Of Thessaloniki- 1st Department of Nephrology
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Thessaloniki, Greece, 57010
- Geniko Nosokomeio Thessalonikis George Papanikolaou-Nephrology Department
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Achaia
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Pátrai, Achaia, Greece, 26504
- University General Hospital of Patras | Nephrology Clinic
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Thessaloniki
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Efkarpia, Thessaloniki, Greece, 56429
- General Hospital Of Thessaloniki Papageorgiou-Renal Department
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Hong Kong Island
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Sheung Wan, Hong Kong Island, Hong Kong, 00000
- Tung Wah Hospital
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Hong Kong SAR
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Hong Kong, Hong Kong SAR, Hong Kong, 00000
- Prince of Wales Hospital
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Hong Kong, Hong Kong SAR, Hong Kong, 00000
- Princess Margaret Hospital
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Hong Kong, Hong Kong SAR, Hong Kong, 00000
- Queen Mary Hospital
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Budapest, Hungary, 1097
- Dél-Pesti Centrumkórház - Országos Hematológiai És Infektológiai Intézet
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Kaposvár, Hungary, 7400
- Somogy Varmegyei Kaposi Mor Oktato Korhaz
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Kistarcsa, Hungary, 2143
- Kistarcsai Flor Ferenc Korhaz
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Nagykanizsa, Hungary, 8800
- Nagykanizsai Kanizsai Dorottya Korhaz
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Nyíregyháza, Hungary, 4400
- Medifarma-98 Egeszsegugyi, Kereskedelmi es Szolgaltato Kft.
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Pécs, Hungary, 7624
- Pecsi Tudomanyegyetem Klinikai Kozpont
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Szombathely, Hungary, 9700
- Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz
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Gujarat
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Ahmedabad, Gujarat, India, 380052
- Mavani Research Center
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Ahmedabad, Gujarat, India, 380054
- Shalby Hospital
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Kerala
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Thiruvananthapuram, Kerala, India, 695011
- Government Medical College Thiruvananthapuram
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Maharashtra
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Hadapsar, Maharashtra, India, 411013
- Noble Hospital
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Mumbai, Maharashtra, India, 400016
- P. D. Hinduja Hospital and Medical Research Centre
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Nashik, Maharashtra, India, 422002
- Shree Siddhivinayak Maternity & Nursing Home
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National Capital Territory of Delhi
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New Delhi, National Capital Territory of Delhi, India, 110017
- Max Super Speciality Hospital, Saket
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Odisha
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Bhubaneswar, Odisha, India, 751019
- All India Institute of Medical Sciences
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Tamil Nadu
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Chennai, Tamil Nadu, India, 600003
- Madras Medical College
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Telangana
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Telangana, Telangana, India, 500012
- Osmania General Hospital
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West Bengal
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Kolkata, West Bengal, India, 700020
- Institute of Post-Graduate Medical Education and Research
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Ashdod, Israel, 7747629
- Assuta Ashdod Public Hospital (R.A)
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Ashkelon, Israel, 7830604
- Barzilai Medical Center | Department of Nephrology and Hypertension
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Beersheba, Israel, 8410101
- Clalit Health | Soroka Medical Center - Internal Medicine Department
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Haifa, Israel, 3109601
- Rambam Health Corporation
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Kfar Saba, Israel, 4428164
- Meir Medical Center
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Nahariya, Israel, 2210001
- Health Corporation of Galilee Medical Center
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Petah Tikva, Israel, 4941492
- Rabin Medical Center | Beilinson Hospital - Internal Medicine C Department
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Ramat Gan, Israel, 5262000
- Chaim Sheba Medical Center
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Rehovot, Israel, 7610001
- Kaplan Medical Center
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Tel Aviv, Israel, 6423906
- Tel-Aviv Sourasky Medical Center
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Tiberias, Israel, 1528001
- Poria Medical Center | Nephrology and Hypertension Department
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Ẕerifin, Israel, 7030000
- Shamir Medical Center (Assaf Harofeh)
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Campania
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Napoli, Campania, Italy, 80131
- A.O.U. Universita' Degli Studi Della Campania Luigi Vanvitelli - Nefrologia
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Emilia-Romagna
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Bologna, Emilia-Romagna, Italy, 40138
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Nefrologia, Dialisi e Trapianto
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Modena, Emilia-Romagna, Italy, 41124
- Azienda Ospedaliero Universitaria di Modena_Policlinico - Nefrologia, Dialisi e Trapianto di Rene
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Parma, Emilia-Romagna, Italy, 43126
- Azienda Ospedaliero Universitaria Parma - SC Nefrologia
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Reggio Emilia, Emilia-Romagna, Italy, 42123
- Azienda USL IRCCS di Reggio Emilia_Arcispedale Santa Maria Nuova - S.C. Nefrologia e Dialisi
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Lazio
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Rome, Lazio, Italy, 00168
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Nefrologia
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Lombardy
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Desio, Lombardy, Italy, 20832
- Azienda Socio Sanitaria Territoriale Della Brianza_Ospedale Pio XI - Nefrologia e Dialisi
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Legnano, Lombardy, Italy, 20025
- Azienda Socio Sanitaria Territoriale Ovest Milanese_Legnano - Nefrologia e Dialisi
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Pavia, Lombardy, Italy, 27100
- Istituti Clinici Scientifici Maugeri S.p.A._Pavia - Nefrologia
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Ranica, Lombardy, Italy, 24020
- Istituto Ricerche Farmacologiche Mario Negri - Unità Operativa Complessa Malattie Renali
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Rho, Lombardy, Italy, 20017
- Azienda Socio Sanitaria Territoriale Rhodense
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Sicily
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Catania, Sicily, Italy, 95126
- Azienda Ospedaliera Per L'Emergenza Cannizzaro - Nefrologia e Dialisi
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Fukuoka, Japan, 814-0180
- Fukuoka University Hospital
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Fukuoka, Japan, 811-0213
- Social Medical Corporation The Chiyukai Foundation Fukuoka Wajiro Hospital
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Kumamoto, Japan, 861-8520
- Japanese Red Cross Kumamoto Hospital
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Nara, Japan, 630-8581
- Nara Prefecture General Medical Center
-
Saga, Japan, 840-8571
- Saga-Ken Medical Centre Koseikan
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Saitama, Japan, 330-8553
- Japanese Red Cross Saitama Hospital
-
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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
-
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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
-
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Hyōgo
-
Kobe, Hyōgo, Japan, 650-0017
- Kobe University Hospital
-
Nishinomiya, Hyōgo, Japan, 662-0918
- Hyogo Prefectural Nishinomiya Hospital
-
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Ibaraki
-
Toride, Ibaraki, Japan, 302-0022
- JA Toride Medical Center
-
Tsuchiura, Ibaraki, Japan, 300-0028
- Tsuchiura Kyodo General Hospital
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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
-
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Iwate
-
Morioka, Iwate, Japan, 020-0066
- Iwate Prefectural Central Hospital
-
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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
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Nagano
-
Matsumoto, Nagano, Japan, 390-8621
- Shinshu University Hospital
-
Matsumoto, Nagano, Japan, 390-1401
- Matsumoto City Hospital
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Okayama-ken
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Kurashiki, Okayama-ken, Japan, 701-0192
- Kawasaki Medical School Hospital
-
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Osaka
-
Sakai, Osaka, Japan, 591-8025
- Osaka Rosai Hospital
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Saitama
-
Irima-gun, Saitama, Japan, 350-0495
- Saitama Medical University Hospital
-
Koshigaya, Saitama, Japan, 343-8577
- Koshigaya Municipal Hospital
-
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Shizuoka
-
Hamamatsu, Shizuoka, Japan, 430-8558
- Seirei Hamamatsu General Hospital
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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
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Yamanashi
-
Chūō, Yamanashi, Japan, 409-3898
- University of Yamanashi Hospital
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-
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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
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Muar town, Malaysia, 84000
- Hospital Pakar Sultanah Fatimah
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Negeri Sembilan, Malaysia, 70300
- Hospital Tuanku Jaafar | Nephrology Department
-
Perak, Malaysia, 30450
- Hospital Raja Permaisuri Bainun
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Perak, Malaysia, 32040
- Hospital Seri Manjung
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Pulau Pinang, Malaysia, 10450
- Hospital Pulau Pinang
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Selangor
-
Shah Alam, Selangor, Malaysia, 68100
- Hospital Selayang
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Aguascalientes, Mexico, 20124
- Sitio Alfredo Chew Wong | Aguascalientes, Mexico
-
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Aguascalientes
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Missing, Aguascalientes, Mexico, 20230
- Fundacion Cardiovascular de Aguascalientes | Aguascalientes, Mexico
-
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Sinaloa
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Culiacán, Sinaloa, Mexico, 80230
- SINACOR | Culiacan, Mexico
-
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Veracruz
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Puerto de Veracruz, Veracruz, Mexico, 91900
- Sociedad de Metabolismo y Corazon S.C. | Veracruz, Mexico
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Leiria, Portugal, 2410-197
- Centro Hospitalar de Leiria | Santo Andre Hospital - Research Center
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Lisbon, Portugal, 1069-166
- Centro Hospitalar Universitario de Lisboa Central | Hospital Curry Cabral - Nephrology Department
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Lisbon District
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Carnaxide, Lisbon District, Portugal, 2790-134
- Unidade Local De Saúde De Lisboa Ocidental E.P.E.
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Santarém District
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Torres Novas, Santarém District, Portugal, 2350-754
- Centro Hospitalar do Medio Tejo | Unidade de Torres Novas - Nephrology Department
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Setúbal District
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Almada, Setúbal District, Portugal, 2805-267
- Unidade Local de Saude Almada-Seixal | Hospital Garcia de Orta - Research Department
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Arkhangelsk, Russia, 163001
- First City Clinical Hospital n.a. E.E. Volosevich
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Izhevsk, Russia, 426063
- Izhevsk City Clinical Hospital #9
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Kemerovo, Russia, 650066
- Kemerovo Regional Clinical Hospital
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Moscow, Russia, 117292
- City clinical hospital n.a. V.V. Vinogradov
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Moscow, Russia, 123182
- City Hospital #52
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Omsk, Russia, 644112
- City Clinical Hospital of Emergency Care #1
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Rostov-on-Don, Russia, 344022
- Rostov State Medical University
-
Saint Petersburg, Russia, 197082
- Limited liability company "MK-Med"
-
Saratov, Russia, 410030
- Saratov City Clinical Hospital #9
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Sestroretsk, Russia, 197706
- City clinical hospital #40 Sestroretsk
-
Voronezh, Russia, 394018
- Voronezh Regional Clinical Consultancy-Diagnostic Center
-
Yaroslavl, Russia, 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
-
-
-
-
-
Busan, South Korea, 47392
- Inje University Busan Paik Hospital
-
Daejeon, South Korea, 35015
- Chung Nam National University Hospital
-
Gyeonggi-do, South Korea, 425-707
- Ansan Hospital | Nephrology
-
Seoul, South Korea, 5278
- Kyung Hee University Hospital at Gangdong
-
Seoul, South Korea, 7061
- Seoul National University Boramae Medical Center
-
Seoul, South Korea, 7441
- KangNam Sacred Heart Hospital
-
Seoul, South Korea, 06351
- Samsung Medical Center - Cardiology
-
-
Gang''weondo
-
Wŏnju, Gang''weondo, South Korea, 26426
- Yonsei University Wonju Christian Hospital
-
-
Gyeonggido
-
Anyang-si, Gyeonggido, South Korea, 14068
- Hallym University Sacred Heart Hospital
-
Goyang-si, Gyeonggido, South Korea, 411-706
- Inje University Ilsan Paik Hospital
-
Goyang-si, Gyeonggido, South Korea, 10326
- Dongguk University Ilsan Hospital
-
Seongnam-si, Gyeonggido, South Korea, 13496
- CHA Bundang Medical Center | Nephrology
-
-
Incheon Gwang''yeogsi
-
Incheon, Incheon Gwang''yeogsi, South Korea, 21431
- The Catholic University of Korea, Incheon St.Mary's Hospital
-
-
Seoul
-
Teugbyeolsi, Seoul, South Korea, 134-701
- Kangdong Sacred Heart Hospital
-
-
Seoul Teugbyeolsi
-
Seoul, Seoul Teugbyeolsi, South Korea, 3080
- Seoul National University Hospital
-
Seoul, Seoul Teugbyeolsi, South Korea, 03312
- The Catholic Univ. of Korea Eunpyeong St. Mary's Hospital
-
Seoul, Seoul Teugbyeolsi, South Korea, 03722
- Severance Hospital, Yonsei University Health System - Cardiology
-
-
-
-
-
Barcelona, Spain, 08003
- Hospital del Mar | Nephrology Department
-
Barcelona, Spain, 08035
- Hospital Universitari Vall D Hebron | Nefrologia
-
Madrid, Spain, 28034
- Hospital Universitario Ramon Y Cajal | Medicina Interna
-
Madrid, Spain, 28041
- Hospital Universitario 12 De Octubre | Nefrologia
-
Valencia, Spain, 46010
- Hospital Clinico Universitario De Valencia | Nefrologia
-
Valencia, Spain, 46017
- Hospital Universitario Dr Peset Aleixandre | Nefrologia
-
Valencia, Spain, 46026
- Hospital Universitario Y Politecnico La Fe | Nefrologia
-
-
A Coruña
-
Ferrol, A Coruña, Spain, 15405
- Area Sanitaria De Ferrol | Medicina Interna
-
-
Barcelona
-
L'Hospitalet de Llobregat, Barcelona, Spain, 8907
- Bellvitge Hospital Universitari | Nefrologia
-
-
Lugo
-
Burela de Cabo, Lugo, Spain, 27880
- Hospital Publico Da Marina | Nefrologia
-
-
Madrid
-
Alcalá de Henares, Madrid, Spain, 28805
- Hospital Universitario Central De Asturias | Nefrologia
-
-
-
-
-
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
-
-
-
-
-
Gloucester, United Kingdom, GL1 3NN
- Gloucestershire Hospitals NHS Foundation Trust | Gloucestershire Royal Hospital - Nephrology
-
-
Greater London
-
London, Greater London, United Kingdom, E1 1BB
- Barts Health NHS Trust - Royal London Hospital - Nephrology
-
London, Greater London, United Kingdom, SE5 9RS
- King's College Hospital NHS Foundation Trust | King's College Hospital - Nephrology Department
-
-
Kent
-
Canterbury, Kent, United Kingdom, CT1 3NG
- Kent and Canterbury Hospital | Renal Research Delivery Team
-
-
South Yorkshire
-
Sheffield, South Yorkshire, United Kingdom, S5 7AU
- Sheffield Teaching Hospitals NHS Foundation Trust | Northern General Hospital - NIHR Sheffield Clinical Research Facility
-
-
Wales
-
Cardiff, Wales, United Kingdom, CF14 4XW
- Cardiff and Vale University Health Board | University Hospital of Wales - Nephrology and Transplant
-
-
-
-
Alabama
-
Huntsville, Alabama, United States, 35805
- Nephrology Consultants, LLC
-
-
California
-
Chula Vista, California, United States, 91910
- Balboa Research SMO+ - Chula Vista - West
-
El Centro, California, United States, 92243
- Balboa Research SMO+ - El Centro
-
Los Angeles, California, United States, 90095
- UCLA Clinical and Translational Research Center - Nephrology
-
Poway, California, United States, 92064
- Balboa Nephrology Medical Group - Poway
-
San Dimas, California, United States, 91773
- North America Research Institute - San Dimas
-
South Gate, California, United States, 90280
- United Clinical Research & Innovations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- University of Colorado | Renal Research Office
-
-
Connecticut
-
Middlebury, Connecticut, United States, 55404
- DaVita Clinical Research | Middlebury, CT
-
New Haven, Connecticut, United States, 06520
- Yale University | Nephrology Clinical Research
-
Waterbury, Connecticut, United States, 06708
- Chase Medical Research, LLC
-
-
Florida
-
Boca Raton, Florida, United States, 33431
- Research Physicians Network Alliance
-
Boca Raton, Florida, United States, 33487
- Florida Kidney Physicians - Boca Raton
-
Orlando, Florida, United States, 32804
- AdventHealth Translational Research Institute
-
-
Georgia
-
Atlanta, Georgia, United States, 30303
- Grady Memorial Hospital - Endocrinology
-
Augusta, Georgia, United States, 30904
- Southeastern Clinical Research Institute, LLC
-
Macon, Georgia, United States, 31201
- Central Georgia Kidney Specialists - Macon
-
-
Idaho
-
Meridian, Idaho, United States, 83642
- Frenova Renal Research | Boise Kidney and Hypertension
-
-
Illinois
-
Chicago, Illinois, United States, 60643
- Research by Design, LLC | Chicago, IL
-
Chicago, Illinois, United States, 60611
- Northwestern Medicine - Feinberg School of Medicine - Nephrology and Hypertension
-
Hinsdale, Illinois, United States, 60521
- Nephrology Associates of Northern Illinois and Indiana - Hinsdale
-
-
Iowa
-
Iowa City, Iowa, United States, 52242
- University of Iowa Health Care Medical Center - Cardiology
-
-
Kansas
-
Kansas City, Kansas, United States, 66160
- KUMC Clinical and Translational Science Unit - Nephrology
-
Wichita, Kansas, United States, 67214
- Kansas Nephrology Research Institute
-
Wichita, Kansas, United States, 67214
- Wichita Nephrology Group, PA
-
-
Louisiana
-
Shreveport, Louisiana, United States, 71101
- Northwest Louisiana Nephrology - Shreveport - 1800 Buckner St.
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Johns Hopkins Hospital - Nephrology
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02111
- Tufts Medical Center | Nephrology Department
-
-
Minnesota
-
Edina, Minnesota, United States, 55435
- DaVita Clinical Research | Edina, MN
-
-
Mississippi
-
Jackson, Mississippi, United States, 39216
- University Hospital - UMMC - Nephrology
-
-
Missouri
-
Kansas City, Missouri, United States, 64111
- Clinical Research Consultants, a JCCT Company
-
St Louis, Missouri, United States, 63136
- St. Louis Heart and Vascular, PC - Christian Hospital Office
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87131
- UNM Clinical and Translational Science Center - Nephrology
-
-
North Carolina
-
Asheville, North Carolina, United States, 28801
- Mountain Kidney & Hypertension Associates
-
Chapel Hill, North Carolina, United States, 27514
- UNC Hospitals Outpatient Center at Eastowne - Nephrology
-
Greenville, North Carolina, United States, 27834
- East Carolina University | Nephrology & Hypertension
-
Wilmington, North Carolina, United States, 28401
- Eastern Nephrology Associates | Wilmington
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Cleveland Clinic | Urological and Kidney Department
-
Cleveland, Ohio, United States, 44106
- UH Cleveland Medical Center - Nephrology
-
-
Pennsylvania
-
Bethlehem, Pennsylvania, United States, 18017
- Northeast Clinical Research Center | Bethlehem, PA
-
Danville, Pennsylvania, United States, 17822
- Geisinger Medical Center - Nephrology
-
Philadelphia, Pennsylvania, United States, 19140
- Temple Health - Nephrology
-
-
South Carolina
-
Orangeburg, South Carolina, United States, 29118
- South Carolina Clinical Reserach
-
-
Tennessee
-
Knoxville, Tennessee, United States, 37923
- Knoxville Kidney Center, PLLC
-
Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical Center - Nephrology Clinical Trials Center
-
-
Texas
-
Dallas, Texas, United States, 75230
- Dallas Renal Group - Medical City
-
El Paso, Texas, United States, 79902
- El Paso Medical Research Institute (MedResearch Inc) | El Paso, TX
-
Houston, Texas, United States, 77054
- DaVita Clinical Research | Houston, TX
-
McAllen, Texas, United States, 78503
- Gamma Medical Research, Inc.
-
San Antonio, Texas, United States, 78212
- Clinical Advancement Center, PLLC
-
San Antonio, Texas, United States, 78207
- Texas Diabetes Institute - Renal Clinic
-
Shenandoah, Texas, United States, 77384
- DaVita Clinical Research | North Houston, TX
-
-
Utah
-
Salt Lake City, Utah, United States, 84132
- University of Utah School of Medicine | Kidney Research Clinic
-
South Salt Lake, Utah, United States, 84115
- Utah Kidney Research Institute | Salt Lake City, UT
-
-
Virginia
-
Fairfax, Virginia, United States, 22033
- Nephrology Associates of Northern Virginia - Fair Oaks
-
Woodbridge, Virginia, United States, 22192
- Mendez Center For Clinical Research | Woodbridge, VA
-
-
Washington
-
Spokane Valley, Washington, United States, 99204
- Providence Medical Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
A clinical diagnosis of chronic kidney disease and:
- Urine albumin/creatinine ratio (UACR) of ≥ 200 but ≤ 3500 mg/g and estimated glomerular filtration rate (eGFR) ≥ 25 but < 90 mL/min/1.73m^2 at screening, and
- Documentation of albuminuria/proteinuria in the participant's medical records at least 3 months prior to screening.
- Stable and maximum tolerated labeled dose of an Angiotensin-converting enzyme inhibitor (ACEI) or Angiotensin receptor blocker (ARB) for at least 4 weeks prior to screening
- K+ ≤ 4.8 mmol/L at screening
Exclusion Criteria:
- Established diagnosis of Type 1 or 2 Diabetes mellitus, or HbA1c ≥ 6.5% (48 mmol/mol)
- Autosomal dominant or autosomal recessive polycystic kidney disease
- Lupus nephritis or anti-neutrophilic cytoplasmic autoantibody (ANCA) -associated vasculitis or any other primary or secondary kidney disease requiring immunosuppressive therapy within 6 months prior to screening
- Symptomatic heart failure with reduced ejection fraction with class 1A indication for Mineralocorticoid receptor antagonists (MRAs)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
Participants will receive placebo.
|
Tablet, once daily, oral
|
|
Experimental: Finerenone (BAY94-8862)
Participants will receive finerenone.
|
Tablet, 10 mg or 20 mg, once daily (OD), oral
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean rate of change as measured by the total slope of eGFR from baseline to Month-32.
Time Frame: From baseline to month 32
|
eGFR: Estimated glomerular filtration rate
|
From baseline to month 32
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Time to the composite of kidney failure, sustained eGFR decline of >= 57%, heart failure hospitalization or Cardiovascular (CV) death
Time Frame: Up to end of study visit (up to approximately 49 months)
|
Up to end of study visit (up to approximately 49 months)
|
|
Time to the composite of kidney failure or sustained eGFR decline of >= 57%
Time Frame: Up to end of study visit (up to approximately 49 months)
|
Up to end of study visit (up to approximately 49 months)
|
|
Time to the composite to heart failure hospitalization or CV death
Time Frame: Up to end of study visit (up to approximately 49 months)
|
Up to end of study visit (up to approximately 49 months)
|
|
Number of participants with Treatment-emergent adverse events (TEAEs), Treatment-emergent serious adverse events (TESAEs) and Adverse events of special interest (AESI)
Time Frame: Up to approximately 50 months
|
Up to approximately 50 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Pathologic Processes
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Chronic Disease
- Disease Attributes
- Renal Insufficiency
- Kidney Diseases
- Renal Insufficiency, Chronic
- Substandard Drugs
- Pharmaceutical Preparations
- finerenone
Other Study ID Numbers
- 21177
- 2021-000421-27 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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