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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05047263
Other study ID # 21177
Secondary ID 2021-000421-27
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date September 21, 2021
Est. completion date February 9, 2026

Study information

Verified date May 2024
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1584
Est. completion date February 9, 2026
Est. primary completion date January 12, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Finerenone (BAY94-8862)
Tablet, 10 mg or 20 mg, once daily (OD), oral
Placebo
Tablet, once daily, oral

Locations

Country Name City State
Argentina Asociación de Fomento y Sala de Primeros Auxilios Berazategui Buenos Aires
Argentina Centro de Investigación y Prevención Cardiovascular Buenos Aires
Argentina Centro de Investigaciones Metabólicas Buenos Aires Ciudad Auton. De Buenos Aires
Argentina Centro de Investigaciones Clínicas Caba Ciudad Auton. De Buenos Aires
Argentina Clinica Privada Velez Sarsfield Córdoba
Argentina Centro de Investigaciones Medicas Lanus | Research Department Lanus Buenos Aires
Argentina Instituto de Investigaciones Clínicas Mar del Plata Buenos Aires
Argentina Centro de Rehabilitacion Cardiovascular | San Luis, Argentina San Luis
Argentina Centro de Investigaciones Clinicas del Litoral Santa Fe
Argentina Clinica de Nefrologia Urologia y Enfermedades Cardiovascular Santa Fe
Australia Sunshine Coast University Hospital Birtinya Queensland
Australia Eastern Health Integrated Renal Service Box Hill
Australia Concord Repatriation General Hospital Concord New South Wales
Australia St George Hospital Kogarah New South Wales
Australia Melbourne Renal Research Group Reservoir Victoria
Australia Sunshine Hospital St. Albans Victoria
Australia Illawarra Shoalhaven Local Health District Wollongong New South Wales
Australia Princess Alexandra Hospital Australia Woolloongabba
Belgium CU Saint-Luc/UZ St-Luc Bruxelles - Brussel
Belgium UZ Gent Gent
Belgium AZ Groeninge Campus Kennedylaan | Nephrology Kortrijk West-Vlaanderen
Belgium UZ Leuven Gasthuisberg Leuven
Belgium CHU de Liège Liege
Belgium AZ Delta / Nephrology Roeselare
Bulgaria Medical Center ''4Life'' Burgas
Bulgaria Viva Phoenix Medical Center | Clinical Trials Department Dobrich
Bulgaria Multiprofile Hospital for Active Treatment St. Ivan Rilski - Gorna Oryahovitsa | Nephrology Department Gorna Oryahovitsa
Bulgaria Medical Center Hera - Montana Montana
Bulgaria ¿ultidisc. hosp. for act. treatm. Sveti Georgi - Pernik OOD Pernik
Bulgaria Diagnostic Consulting Center XX Sofia
Bulgaria Medical Center Zara-Med EOOD | Nephrology Department Stara Zagora
Bulgaria Medical Center ''Nevromedics'' Veliko Tarnovo
China The First Affiliated Hospital of Baotou Medical College Baotou Inner Mongolia
China Beijing Anzhen Hospital, Capital Medical University Beijing
China Beijing Tsinghua Changgung Hospital Beijing
China China-Japan Friendship Hospital Beijing
China Chinese PLA General Hospital Beijing
China The First Affiliated Hospital of Bengbu Medical College Bengbu Anhui
China The Second Hospital of Jilin University Changchun Jilin
China 1st Peopl's Hosp of Changzhou 3rd Affil Hosp of Soochow Univ Changzhou Jiangsu
China Sichuan University West China Hospital Chengdu Sichuan
China SichuanAcademyofMedicalSciences&SichuanProvincialPeople'sHos Chengdu Sichuan
China Daping Hospital, 3rd Affil Hosp. 3rd Military Med Univ PLA Chongqing
China The First Affiliated Hospital of Dalian Medical University Dalian Liaoning
China The First Affiliated Hospital of Guangzhou University of TCM Guangzhou Guangdong
China The First Affiliated Hospital of Jinan University Guangzhou Guangdong
China Zhujiang Hospital of Southern Medical University Guangzhou Guangdong
China The Affiliated Hospital of Guizhou Medical University Guiyang Guizhou
China The Second Hospital of Anhui medical university Hefei Anhui
China Huai'an First People's Hospital, Nanjing Medical University Huai'An Jiangsu
China Huizhou Central People's Hospital Huizhou Guangdong
China Jiangmen Wuyi Hospital of traditional Chinese Medicine Jiangmen Guangdong
China Qilu Hosp., Shandong Univ. Jinan Shandong
China Lanzhou University Second Hospital Lanzhou Gansu
China Liuzhou Worker's Hospital Liuzhou Guangxi
China People's Hospital of Liuzhou City Liuzhou Guangxi
China The First Affiliated Hospital of NanChang University Nanchang Jiangxi
China Jiangsu Province Hospital of Chinese Medicine Nanjing Jiangsu
China Zhongda Hospital Southeast University Nanjing Jiangsu
China Hwa Mei Hospital, University of Chinese Academy Sciences Ningbo Zhejiang
China PingXiang People's Hospital Pingxiang Jiangxi
China Central Hospital of Minhang District, Shanghai Shanghai
China Shanghai Fifth People's Hospital,Fudan University Shanghai
China Xinhua Hos Affiliated to SH Jiaotong Uni School of Medicine Shanghai
China Zhongshan Hospital, Fudan University Shanghai
China Siping Central Hospital Siping Jilin
China Tianjin Union Medicine Centre (People's Hospital of Tianjin) Tianjin
China The First Affiliated Hospital of Xinjiang Medical University Urumchi Xinjiang
China The First Affiliated Hospital of Wenzhou Medical Univ (New) Wenzhou Zhejiang
China Renmin Hospital of Wuhan University Wuhan Hubei
China Wuhan Hospital Of Traditional Chinese And Western Medicine Wuhan Hubei
China Wuhan No. 4 Hospital Wuhan Hubei
China The First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shanxi
China The First Affiliated Hospital of Xiamen University Xiamen Fujian
China General Hospital of Ningxia Medical University Yinchuan Ningxia
China The First affiliated Hospital of Hebei North University Zhangjiakou Hebei
Czechia Fakultní nemocnice Brno - Interni gastroenterologicka klinika Brno
Czechia MUDr.Petr Bucek s.r.o. Frydek-Mistek
Czechia CTC Hodonin sro Hodonin
Czechia Privamed s.r.o. Plzen
Czechia Vseobecna fakultni nemocnice v Praze Praha 2
Czechia Nefrologicka ambulance Praha 4
Czechia Nefromed s.r.o. Praha 6
Czechia Vestra Clinics s.r.o. Rychnov nad Kneznou
Czechia Nemocnice Znojmo Znojmo
Denmark Rigshospitalet, Dept Nefrology Copenhagen
Denmark Sydvestjysk Sygehus Esbjerg Esbjerg
Denmark Herlev Hospital - Nefrology dept. Herlev
Denmark Holbæk Sygehus Holbæk
Denmark Region Midtjylland | Regionshospitalet Godstrup - Nephrology Department Holstebro
Denmark Odense University Hospital | Department of Kidney Medicine Odense C
Greece General Hospital of Arta Arta
Greece HIPPOKRATION General Hospital of Athens Athens
Greece LAIKO General Hospital of Athens Athens
Greece University General Hospital of Heraklion Heraklion
Greece Ioannina University General Hospital Ioannina
Greece University General Hospital of Patras | Nephrology Clinic Patra
Greece PAPANIKOLAOU General Hospital Thessaloniki Pilea Chortiatis
Greece Hippokration General Hospital of Thessaloniki Thessaloniki
Greece Papageorgiou General Hospital of Thessaloniki Thessaloniki
Hong Kong Queen Mary Hospital Hong Kong
Hong Kong Princess Margaret Hospital Lai Chi Kok
Hong Kong Prince of Wales Hospital Shatin
Hong Kong Tung Wah Hospital Sheung Wan
Hungary Somogy Varmegyei Kaposi Mor Oktato Korhaz Kaposvar
Hungary Kistarcsai Flor Ferenc Korhaz Kistarcsa
Hungary Nagykanizsai Kanizsai Dorottya Korhaz Nagykanizsa
Hungary Medifarma-98 Egeszsegugyi, Kereskedelmi es Szolgaltato Kft. Nyiregyhaza
Hungary Pecsi Tudomanyegyetem Klinikai Kozpont Pecs
Hungary Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz Szombathely
India Mavani Research Center Ahmedabad
India Shalby Hospital Ahmedabad Gujar?t
India All India Institute of Medical Sciences Bhubaneswar Delhi
India Madras Medical College Chennai Tamil Nadu
India Noble Hospital Hadapsar Maharashtra
India Institute of Post-Graduate Medical Education and Research Kolkata West Bengal
India P. D. Hinduja Hospital and Medical Research Centre Mumbai Maharashtra
India Shree Siddhivinayak Maternity & Nursing Home Nashik Maharashtra
India Max Super Speciality Hospital, Saket New Delhi Delhi
India Osmania General Hospital Telangana
India Government Medical College Thiruvananthapuram Thiruvananthapuram Kerala
Israel Assuta Ashdod Ashdod
Israel Barzilai Medical Center Ashkelon
Israel Soroka University Medical Center Beer Sheva
Israel Rambam Health Corporation Haifa
Israel Meir Medical Center Kfar Saba
Israel Health Corporation of Galilee Medical Center Nahariya
Israel Clalit Health Services Rabin Medical Center-Beilinson Campus Petah Tikva
Israel Chaim Sheba Medical Center Ramat Gan
Israel Kaplan Medical Center Rehovot
Israel Tel-Aviv Sourasky Medical Center Tel Aviv
Israel The Baruch Padeh Medical Center, Poriya Tiberias
Israel Shamir Medical Center (Assaf Harofeh) Zerifin
Italy Istituto Ricerche Farmacologiche Mario Negri IRCCS Bergamo Lombardia
Italy A.O.U. di Bologna Policlinico S.Orsola Malpighi Bologna Emilia-Romagna
Italy ASST Ovest Milanese Milano Lombardia
Italy ASST Rhodense Milano Lombardia
Italy A.O.U. di Modena - Policlinico Modena Emilia-Romagna
Italy ASST di Monza Monza Brianza Lombardia
Italy A.O.U. Luigi Vanvitelli Napoli Campania
Italy A.O.U. di Parma Parma Emilia-Romagna
Italy IRCCS Istituti Clinici Scientifici Maugeri SpA SB Pavia Lombardia
Italy AUSL-IRCCS di Reggio Emilia Reggio Emilia Emilia-Romagna
Italy Fondazione Policlinico Universitario Agostino Gemelli IRCCS Roma Lazio
Japan Juntendo University Hospital Bunkyo-ku Tokyo
Japan The University of Tokyo Hospital Bunkyo-ku Tokyo
Japan University of Yamanashi Hospital Chuo Yamanashi
Japan Fukuoka University Hospital Fukuoka
Japan Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital Fukuoka
Japan Seirei Hamamatsu General Hospital Hamamatsu Shizuoka
Japan Hiratsuka Kyosai Hospital Hiratsuka Kanagawa
Japan Aso Iizuka Hospital Iizuka Fukuoka
Japan Saitama Medical University Hospital Irima-gun Saitama
Japan Tokai University Hospital Isehara Kanagawa
Japan Nihon University Itabashi Hospital Itabashi-ku Tokyo
Japan Kanazawa University Hospital Kanazawa Ishikawa
Japan National Hospital Organization Kanazawa Medical Center | Clinical Trial Management Office Kanazawa Ishikawa
Japan St. Marianna University Hospital Kawasaki Kanagawa
Japan JCHO Kyushu Hospital Kitakyushu Fukuoka
Japan Kokura Memorial Hospital Kitakyushu Fukuoka
Japan Kobe University Hospital Kobe Hyogo
Japan Koshigaya Municipal Hospital Koshigaya Saitama
Japan Japanese Red Cross Kumamoto Hospital Kumamoto
Japan Kawasaki Medical School Hospital Kurashiki Okayama
Japan Matsumoto City Hospital Matsumoto Nagano
Japan Shinshu University Hospital Matsumoto Nagano
Japan Central Japan International Medical Center Minokamo Gifu
Japan Iwate Prefectural Central Hospital Morioka Iwate
Japan Chubu Rosai Hospital Nagoya Aichi
Japan Daido Clinic Nagoya Aichi
Japan Nagoya City University Hospital Nagoya Aichi
Japan Nara Prefecture General Medical Center Nara
Japan Hyogo Prefectural Nishinomiya Hospital Nishinomiya Hyogo
Japan Saga-Ken Medical Centre Koseikan Saga
Japan Japanese Red Cross Saitama Hospital Saitama
Japan Osaka Rosai Hospital Sakai Osaka
Japan Tokyo Medical University Hospital Shinjuku-ku Tokyo
Japan JA Toride Medical Center Toride Ibaraki
Japan Tsuchiura Kyodo General Hospital Tsuchiura Ibaraki
Japan Juntendo University Urayasu Hospital Urayasu Chiba
Japan Kainan Hospital Yatomi Aichi
Japan Saiseikai Yokohamashi Nanbu Hospital Yokohama Kanagawa
Japan Yokohama City University Hospital Yokohama Kanagawa
Japan Yokohama Sakae Kyosai Hospital Yokohama Kanagawa
Korea, Republic of Hallym University Sacred Heart Hospital Anyang-si Gyeonggido
Korea, Republic of Inje University Busan Paik Hospital Busan
Korea, Republic of Chung Nam National University Hospital Daejeon
Korea, Republic of Dongguk University Ilsan Hospital Goyang-si Gyeonggido
Korea, Republic of Inje University Ilsan Paik Hospital Goyang-si Gyeonggido
Korea, Republic of Korea University Ansan Hospital Gyeonggi-do
Korea, Republic of The Catholic University of Korea, Incheon St.Mary's Hospital Incheon Incheon Gwang''yeogsi
Korea, Republic of Bundang Cha Hospital Seongnam-si Gyeonggido
Korea, Republic of Kangnam Sacred Heart Hospital Seoul
Korea, Republic of Kyung Hee University Hospital at Gangdong Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul National University Boramae Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul Seoul Teugbyeolsi
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul
Korea, Republic of The Catholic Univ. of Korea Eunpyeong St. Mary's Hospital Seoul Seoul Teugbyeolsi
Korea, Republic of Kangdong Sacred Heart Hospital Teugbyeolsi Seoul
Korea, Republic of Yonsei University Wonju Christian Hospital Wonju Gang''weondo
Malaysia Hospital Sultan Abdul Halim Kedah
Malaysia Hospital Kuala Lumpur Kuala Lumpur
Malaysia University Malaya Medical Centre Kuala Lumpur
Malaysia Hospital Pakar Sultanah Fatimah Muar
Malaysia Hospital Tuanku Ja'afar Negeri Sembilan
Malaysia Hospital Tengku Ampuan Afzan Pahang
Malaysia Hospital Raja Permaisuri Bainun Perak
Malaysia Hospital Seri Manjung Perak
Malaysia Hospital Pulau Pinang Pulau Pinang
Malaysia Hospital Kajang Selangor
Malaysia Hospital Selayang Shah Alam
Mexico Fundación Cardiovascular De Aguascalientes Ac Aguascalientes
Mexico Sitio Alfredo Chew Wong | Aguascalientes, Mexico Aguascalientes
Mexico Centro para el Desarrollo de la Medicina y de Asistencia Méd Culiacán Sinaloa
Mexico Sociedad de Metabolismo y Corazón S.C. ( SOMECO) Puerto de Veracruz Veracruz
Portugal Hospital Garcia de Orta | Research Department Almada
Portugal Centro Hospitalar de Lisboa Ocidental | Clin Res Dept Carnaxide Lisboa
Portugal Centro Hospitalar de Leiria | Santo Andre Hospital - Research Center Leiria
Portugal Centro Hospitalar Universitario de Lisboa Central | Hospital Curry Cabral - Nephrology Department Lisboa
Portugal Centro Hospitalar do Medio Tejo | Unidade de Torres Novas - Nephrology Department Torres Novas Santarém
Russian Federation Izhevsk City Clinical Hospital #9 Izhevsk
Russian Federation Kemerovo Regional Clinical Hospital Kemerovo
Russian Federation City Clinical Hospital of Emergency Care #1 Omsk
Russian Federation Rostov State Medical University Rostov-on-Don
Russian Federation Limited liability company "MK-Med" Saint-Petersburg
Russian Federation Saratov City Clinical Hospital #9 Saratov
Russian Federation Voronezh Regional Clinical Consultancy-Diagnostic Center Voronezh
Russian Federation Regional Clinical Hospital Yaroslavl Yaroslavl
Singapore Khoo Teck Puat Hospital Singapore
Singapore National University Hospital Singapore
Singapore Singapore General Hospital Singapore
Singapore SingHealth Polyclinics - Pasir Ris Singapore
Singapore Tan Tock Seng Hospital Singapore
Spain Hospital Principe de Asturias Alcalá de Henares Madrid
Spain Ciutat Sanitaria i Universitaria de la Vall d'Hebron Barcelona
Spain Hospital del Mar | Nephrology Department Barcelona
Spain Servicio Galego de Saude | Hospital Publico da Marina - Department of Nephrology Burela Lugo
Spain Complexo HU Ferrol | Nefrología Ferrol A Coruña
Spain Hospital Univ. Bellvitge | Nefrología L'Hospitalet de Llobregat Barcelona
Spain H Univ. 12 de Octubre | Nefrología Madrid
Spain Hospital Universitario Ramon y Cajal | Departamento de Medicina Interna Madrid
Spain Hospital Clínico Univ. Valencia | Nefrología Valencia
Spain Hospital Universitari i Politècnic La Fe Valencia
Spain Hospital Universitario Dr. Peset Valencia
Taiwan Changhua Christian Hospital Changhua
Taiwan National Taiwan University Hospital, Hsin-Chu Branch Hsin-Chu Hsinchu
Taiwan Chang Gung Memorial Hospital Kaohsiung Kaohsiung
Taiwan Far Eastern Memorial Hospital | Nephrology Department New Taipei City Taipei
Taiwan China Medical University Hospital Taichung
Taiwan Taichung Veterans General Hospital Taichung
Taiwan National Taiwan University Hospital Taipei
Taiwan Taipei Medical University Hospital Taipei
Taiwan Chang Gung Memorial Hospital at Linkou Taoyuan
United Kingdom Kent and Canterbury Hospital | Renal Research Delivery Team Canterbury Kent
United Kingdom University Hospital of Wales Cardiff
United Kingdom Gloucestershire Royal Hospital Gloucester
United Kingdom King's College Hospital - NHS Foundation Trust London
United Kingdom Royal London Hospital London
United Kingdom Northern General Hospital Sheffield South Yorkshire
United States University of New Mexico Albuquerque New Mexico
United States Mountain Kidney & Hypertension Associates Asheville North Carolina
United States Emory University School of Medicine Atlanta Georgia
United States Southeastern Clinical Research Institute, LLC Augusta Georgia
United States University of Colorado Hospital Aurora Colorado
United States Johns Hopkins Hospital/Health System Baltimore Maryland
United States Northeast Clinical Research Center, LLC Bethlehem Pennsylvania
United States Florida Kidney Physicians - Boca Raton Boca Raton Florida
United States Research Physicians Network Alliance Boca Raton Florida
United States Tufts Medical Center Boston Massachusetts
United States UNC Eastowne Medical Office Building Chapel Hill North Carolina
United States Research by Design, LLC Chicago Illinois
United States California Institute of Renal Research - Chula Vista Chula Vista California
United States Cleveland Clinic | Urological and Kidney Department Cleveland Ohio
United States Univ Hosp | UH Cleve MC - Div of Neph & Hyper Res Cleveland Ohio
United States Dallas Renal Group Dallas Texas
United States Geisinger Medical Center Danville Pennsylvania
United States InterMed Consultants Edina Minnesota
United States California Institute of Renal Research, Inc. - El Centro El Centro California
United States MedResearch, Inc. El Paso Texas
United States Nephrology Associates of Northern Virginia Inc. Fairfax Virginia
United States East Carolina University Greenville North Carolina
United States DaVita Clinical Research | Houston, TX Houston Texas
United States Nephrology Consultants, LLC Huntsville Alabama
United States University of Iowa Hospitals & Clinics Iowa City Iowa
United States University of Mississippi Medical Center | Shafi Group Jackson Mississippi
United States Clinical Research Consultants Kansas City Missouri
United States University of Kansas Kansas City Kansas
United States Knoxville Kidney Center Knoxville Tennessee
United States UCLA | Division of Nephrology Los Angeles California
United States Central Georgia Kidney Specialist Macon Georgia
United States Gamma Medical Research, Inc. McAllen Texas
United States Nephrology and Hypertension Associates, P.C. Middlebury Connecticut
United States Vanderbilt University Medical Center Nashville Tennessee
United States Yale University | Nephrology Clinical Research New Haven Connecticut
United States NANI Research, LLC Oak Brook Illinois
United States South Carolina Clinical Research, LLC Orangeburg South Carolina
United States Advent Health Orlando Florida
United States Temple University Hospital Philadelphia Pennsylvania
United States United Clinical Research & Innovations S. Gate California
United States Utah Kidney Research Institute / South Salt Lake S. Salt Lake Utah
United States University of Utah / Kidney Res Clin Salt Lake City Utah
United States Clinical Advancement Center, PLLC San Antonio Texas
United States Univ of Texas Health Science Center | Div of Nephrology San Antonio Texas
United States North America Research Institute San Dimas California
United States Kidney Specialists of North Houston Shenandoah Texas
United States Northwest Louisiana Nephrology Shreveport Louisiana
United States Providence Medical Research Center Spokane Valley Washington
United States Chase Medical Research, LLC Waterbury Connecticut
United States Kansas Nephrology Research Institute, LLC Wichita Kansas
United States Wichita Nephrology Group, PA Wichita Kansas
United States Eastern Nephrology Associates - Wilmington Wilmington North Carolina
United States Mendez Center for Clinical Research, LLC Woodbridge Virginia

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Bulgaria,  China,  Czechia,  Denmark,  Greece,  Hong Kong,  Hungary,  India,  Israel,  Italy,  Japan,  Korea, Republic of,  Malaysia,  Mexico,  Portugal,  Russian Federation,  Singapore,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean rate of change as measured by the total slope of eGFR from baseline to Month-32. eGFR: Estimated glomerular filtration rate From baseline to month 32
Secondary Time to the composite of kidney failure, sustained eGFR decline of >= 57%, heart failure hospitalization or Cardiovascular (CV) death Up to end of study visit (up to approximately 49 months)
Secondary Time to the composite of kidney failure or sustained eGFR decline of >= 57% Up to end of study visit (up to approximately 49 months)
Secondary Time to the composite to heart failure hospitalization or CV death Up to end of study visit (up to approximately 49 months)
Secondary Number of participants with Treatment-emergent adverse events (TEAEs), Treatment-emergent serious adverse events (TESAEs) and Adverse events of special interest (AESI) Up to approximately 50 months
See also
  Status Clinical Trial Phase
Withdrawn NCT04143581 - SGLT2 Inhibitors in Glomerular Hyperfiltration Phase 2
Recruiting NCT01701830 - Serum Omentin-1 and Carotid Atherosclerosis In Non-Diabetic Chronic Kidney Disease N/A