Study Completed

Non-diabetic chronic kidney disease

Bayer Identifier:

21177

ClinicalTrials.gov Identifier:

NCT05047263

EudraCT Number:

2021-000421-27

EU CT Number:

Not Available

A trial to learn how well finerenone works and how safe it is in adult participants with non-diabetic chronic kidney disease

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A

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)

Trial summary

Enrollment Goal

1584

Trial Dates

September 2021 - February 2026

Phase

Phase 3

Could I Receive a placebo

Yes

Products

Finerenone (BAY94-8862)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Shalby Hospital	Ahmedabad, 380054, India
Completed	P. D. Hinduja Hospital and Medical Research Centre	Mumbai, 400016, India
Completed	Osmania General Hospital	Telangana, 500012, India
Completed	Providence Medical Research Center	Spokane Valley, 99204, United States
Completed	Northwest Louisiana Nephrology - Shreveport - 1800 Buckner St.	Shreveport, 71101, United States
Completed	Johns Hopkins Hospital - Nephrology	Baltimore, 21287, United States
Completed	Vanderbilt University Medical Center - Nephrology Clinical Trials Center	Nashville, 37232, United States
Completed	Geisinger Medical Center - Nephrology	Danville, 17822, United States
Completed	Research by Design, LLC \| Chicago, IL	Chicago, 60643, United States
Withdrawn	W. G. (Bill) Hefner VA Medical Center	Salisbury, 28144, United States
Completed	Balboa Research SMO+ - Chula Vista - West	Chula Vista, 91910, United States
Completed	Nephrology Associates of Northern Virginia - Fair Oaks	Fairfax, 22033, United States
Completed	UNC Hospitals Outpatient Center at Eastowne - Nephrology	Chapel Hill, 27514, United States
Completed	South Carolina Clinical Reserach	Orangeburg, 29118, United States
Completed	Central Georgia Kidney Specialists - Macon	Macon, 31201, United States
Completed	Temple Health - Nephrology	Philadelphia, 19140, United States
Completed	UCLA Clinical and Translational Research Center - Nephrology	Los Angeles, 90095, United States
Not yet recruiting	Northwestern Medicine - Feinberg School of Medicine - Nephrology and Hypertension	Chicago, 60611, United States
Active, not recruiting	Yale University \| Nephrology Clinical Research	New Haven, 06520, United States
Completed	Grady Memorial Hospital - Endocrinology	Atlanta, 30303, United States
Completed	DaVita Clinical Research \| North Houston, TX	Shenandoah, 77384, United States
Completed	Rigshospitalet, Copenhagen University Hospital \| Department of Nefrology	Copenhagen, 2100, Denmark
Completed	Region Midtjylland \| Regionshospitalet Godstrup - Nephrology Department	Herning, DK-7400, Denmark
Completed	Region Sjælland \| Holbaek Sygehus - Cardiology department	Holbæk, 4300, Denmark
Completed	Odense University Hospital \| Department of Kidney Medicine	Odense C, 5000, Denmark
Completed	Hospital of South West Jutland \| Department of Endocrinology Research	Esbjerg, 6700, Denmark
Completed	General Hospital of Athens LAIKO	Athens, 11527, Greece
Completed	General Hospital Of Thessaloniki Papageorgiou-Renal Department	Efkarpia, 56429, Greece
Completed	University General Hospital of Patras \| Nephrology Clinic	Patra, 26504, Greece
Completed	Geniko Nosokomeio Thessalonikis George Papanikolaou-Nephrology Department	Thessaloniki, 57010, Greece
Completed	HIPPOKRATION General Hospital of Athens	Athens, 11527, Greece
Completed	General Hospital of Arta \| Nephrology Department	Arta, 47132, Greece
Completed	Istituto Ricerche Farmacologiche Mario Negri - Unità Operativa Complessa Malattie Renali	Ranica, 24020, Italy
Completed	Istituti Clinici Scientifici Maugeri S.p.A._Pavia - Nefrologia	Pavia, 27100, Italy
Completed	A.O.U. Universita' Degli Studi Della Campania Luigi Vanvitelli - Nefrologia	Napoli, 80131, Italy
Completed	Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Nefrologia, Dialisi e Trapianto	Bologna, 40138, Italy
Completed	Azienda Socio Sanitaria Territoriale Della Brianza_Ospedale Pio XI - Nefrologia e Dialisi	Desio, 20832, Italy
Withdrawn	Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli	Reggio Calabria, Italy
Not yet recruiting	Azienda Ospedaliera Per L'Emergenza Cannizzaro - Nefrologia e Dialisi	Catania, 95126, Italy
Completed	Azienda USL IRCCS di Reggio Emilia_Arcispedale Santa Maria Nuova - S.C. Nefrologia e Dialisi	Reggio Emilia, 42123, Italy
Completed	Azienda Ospedaliero Universitaria di Modena_Policlinico - Nefrologia, Dialisi e Trapianto di Rene	Modena, 41124, Italy
Completed	Azienda Ospedaliero Universitaria Parma - SC Nefrologia	Parma, 43126, Italy
Completed	Hallym University Sacred Heart Hospital	Anyang-si, 14068, Korea,_republic_of
Completed	Chung Nam National University Hospital	Daejeon, 35015, Korea,_republic_of
Completed	The Catholic University of Korea, Incheon St.Mary's Hospital	Incheon, 21431, Korea,_republic_of
Completed	Yonsei University Wonju Christian Hospital	Wonju, 26426, Korea,_republic_of
Completed	Dongguk University Ilsan Hospital	Goyang-si, 10326, Korea,_republic_of
Completed	Seoul National University Hospital	Seoul, 3080, Korea,_republic_of
Active, not recruiting	Všeobecná fakultní nemocnice v Praze	Praha 2, 12808, Czech Republic
Completed	Nefrologicka ambulance	Praha 4, 140 00, Czech Republic
Completed	MUDr.Petr Bucek s.r.o.	Frydek-Mistek, 738 01, Czech Republic
Completed	Vestra Clinics s.r.o.	Rychnov nad Kneznou, 516 01, Czech Republic
Completed	Hospital Seri Manjung	Perak, 32040, Malaysia
Completed	Hospital Raja Permaisuri Bainun	Perak, 30450, Malaysia
Completed	Hospital Selayang	Shah Alam, 68100, Malaysia
Completed	Hospital Tengku Ampuan Afzan	Pahang, 25100, Malaysia
Completed	Hospital Sultan Abdul Halim	Kedah, 8000, Malaysia
Completed	Universiti Malaya Medical Centre	Kuala Lumpur, 59100, Malaysia
Completed	Hospital Pulau Pinang	Pulau Pinang, 10450, Malaysia
Completed	Hospital Universitario 12 De Octubre \| Nefrologia	Madrid, 28041, Spain
Completed	Hospital Universitario Y Politecnico La Fe \| Nefrologia	Valencia, 46026, Spain
Completed	Area Sanitaria De Ferrol \| Medicina Interna	Ferrol, 15405, Spain
Completed	Hospital Universitario Central De Asturias \| Nefrologia	Alcalá de Henares, 28805, Spain
Completed	Hospital Universitario Ramon Y Cajal \| Medicina Interna	Madrid, 28034, Spain
Completed	Hospital Universitari Vall D Hebron \| Nefrologia	Barcelona, 08035, Spain
Completed	Hospital Clinico Universitario De Valencia \| Nefrologia	Valencia, 46010, Spain
Completed	Hospital Universitario Dr Peset Aleixandre \| Nefrologia	Valencia, 46017, Spain
Completed	Bellvitge Hospital Universitari \| Nefrologia	L'Hospitalet de Llobregat, 8907, Spain
Completed	Melbourne Renal Research Group	Reservoir, 3073, Australia
Completed	Inje University Ilsan Paik Hospital	Goyang-si, 411-706, Korea,_republic_of
Completed	Samsung Medical Center - Cardiology	Seoul, 06351, Korea,_republic_of
Completed	Seoul National University Boramae Medical Center	Seoul, 7061, Korea,_republic_of
Completed	Kyung Hee University Hospital at Gangdong	Seoul, 5278, Korea,_republic_of
Completed	Taipei Medical University \| Clinical Research Center	Taipei, 110, Taiwan
Completed	Barzilai Medical Center \| Department of Nephrology and Hypertension	Ashkelon, 7830604, Israel
Completed	Meir Medical Center	Kfar Saba, 4428164, Israel
Completed	Centro de Rehabilitacion Cardiovascular \| San Luis, Argentina	San Luis, D5700CGR, Argentina
Completed	CEDIC Centro de Investigación Clínica \| Buenos Aires, Argentina	CABA, C1018DES, Argentina
Completed	Herlev Hospital \| Nephrology Department	Herlev, 2730, Denmark
Completed	CTC Hodonín, s.r.o.	Hodonin, 695 01, Czech Republic
Withdrawn	Vseobecna fakultni nemocnice v Praze	Praha 2, 12808, Czechia
Completed	Utah Kidney Research Institute \| Salt Lake City, UT	South Salt Lake, 84115, United States
Withdrawn	Louis Stokes Cleveland VA Medical Center	Cleveland, 44106, United States
Withdrawn	Renal and Transplant Associates of New England, PC	Springfield, 01107, United States
Completed	Northeast Clinical Research Center \| Bethlehem, PA	Bethlehem, 18017, United States
Completed	Florida Kidney Physicians - Boca Raton	Boca Raton, 33487, United States
Completed	Clinical Advancement Center, PLLC	San Antonio, 78212, United States
Withdrawn	Office of Dr. James E. Race, MD	Dallas, 75224, United States
Completed	DaVita Clinical Research \| Middlebury, CT	Middlebury, 55404, United States
Completed	DaVita Clinical Research \| Houston, TX	Houston, 77054, United States
Completed	Multiprofile Hospital for Active Treatment Sveti Georgi OOD, Pernik - Department of Cardiology	Pernik, 2300, Bulgaria
Completed	Medical Center Hera \| Montana Branch	Montana, 3400, Bulgaria
Completed	Diagnostic-Consultative Center XX \| Nephrology Department	Sofia, 1618, Bulgaria
Completed	Medical Center ’’Nevromedics’’	Veliko Tarnovo, 5600, Bulgaria
Completed	Medical Center ’’4Life’’	Burgas, 8000, Bulgaria
Completed	Multiprofile Hospital for Active Treatment St. Ivan Rilski - Gorna Oryahovitsa \| Nephrology Department	Gorna Oryahovitsa, 5100, Bulgaria
Withdrawn	Center for Medical Research, LLC	Providence, 02908, United States
Completed	Clinical Research Consultants, a JCCT Company	Kansas City, 64111, United States
Completed	Texas Diabetes Institute - Renal Clinic	San Antonio, 78207, United States
Completed	University of Utah School of Medicine \| Kidney Research Clinic	Salt Lake City, 84132, United States
Completed	Balboa Research SMO+ - El Centro	El Centro, 92243, United States
Completed	Balboa Nephrology Medical Group - Poway	Poway, 92064, United States
Completed	East Carolina University \| Nephrology & Hypertension	Greenville, 27834, United States
Completed	University of Iowa Health Care Medical Center - Cardiology	Iowa City, 52242, United States
Completed	KUMC Clinical and Translational Science Unit - Nephrology	Kansas City, 66160, United States
Completed	El Paso Medical Research Institute (MedResearch Inc) \| El Paso, TX	El Paso, 79902, United States
Completed	North America Research Institute - San Dimas	San Dimas, 91773, United States
Completed	Eastern Nephrology Associates \| Wilmington	Wilmington, 28401, United States
Withdrawn	Univ of Chicago \| Hypertension Center	Chicago, 60637, United States
Completed	Mendez Center For Clinical Research \| Woodbridge, VA	Woodbridge, 22192, United States
Completed	Knoxville Kidney Center, PLLC	Knoxville, 37923, United States
Completed	UH Cleveland Medical Center - Nephrology	Cleveland, 44106, United States
Completed	Kansas Nephrology Research Institute	Wichita, 67214, United States
Completed	Southeastern Clinical Research Institute, LLC	Augusta, 30904, United States
Completed	Chase Medical Research, LLC	Waterbury, 06708, United States
Completed	Mountain Kidney & Hypertension Associates	Asheville, 28801, United States
Completed	Tufts Medical Center \| Nephrology Department	Boston, 02111, United States
Completed	UNM Clinical and Translational Science Center - Nephrology	Albuquerque, 87131, United States
Withdrawn	Tidewater Kidney Specialists- Norfolk	Norfolk, 23510, United States
Completed	Cleveland Clinic \| Urological and Kidney Department	Cleveland, 44195, United States
Completed	DaVita Clinical Research \| Edina, MN	Edina, 55435, United States
Completed	University Hospital - UMMC - Nephrology	Jackson, 39216, United States
Completed	University of Colorado \| Renal Research Office	Aurora, 80045, United States
Completed	Iwate Prefectural Central Hospital	Morioka, 020-0066, Japan
Completed	JA Toride Medical Center	Toride, 302-0022, Japan
Completed	Tsuchiura Kyodo General Hospital	Tsuchiura, 300-0028, Japan
Completed	Saitama Medical University Hospital	Irima-gun, 350-0495, Japan
Completed	Japanese Red Cross Saitama Hospital	Saitama, 330-8553, Japan
Completed	Juntendo University Urayasu Hospital	Urayasu, 279-0021, Japan
Completed	Nihon University Itabashi Hospital	Itabashi-ku, 173-8610, Japan
Completed	The University of Tokyo Hospital	Bunkyo-ku, 113-8655, Japan
Completed	Tokyo Medical University Hospital	Shinjuku-ku, 160-0023, Japan
Completed	Tokyo Metropolitan Tama Medical Center	Fuchu, 183-8524, Japan
Completed	Juntendo University Hospital	Bunkyo-ku, 113-8431, Japan
Completed	Hiratsuka Kyosai Hospital	Hiratsuka, 254-8502, Japan
Completed	Yokohama Sakae Kyosai Hospital	Yokohama, 247-8581, Japan
Completed	Tokai University Hospital	Isehara, 259-1193, Japan
Completed	Yokohama City University Hospital	Yokohama, 236-0004, Japan
Completed	St. Marianna University Hospital	Kawasaki, 216-8511, Japan
Completed	Saiseikai Yokohamashi Nanbu Hospital	Yokohama, 234-0054, Japan
Completed	National Hospital Organization Kanazawa Medical Center \| Clinical Trial Management Office	Kanazawa, 920-8650, Japan
Completed	University of Yamanashi Hospital	Chuo, 409-3898, Japan
Withdrawn	Japanese Red Cross Society Suwa Hospital	Suwa, 392-8510, Japan
Completed	Shinshu University Hospital	Matsumoto, 390-8621, Japan
Completed	Matsumoto City Hospital	Matsumoto, 390-1401, Japan
Completed	Central Japan International Medical Center	Minokamo, 505-8510, Japan
Completed	Seirei Hamamatsu General Hospital	Hamamatsu, 430-8558, Japan
Completed	Kainan Hospital	Yatomi, 498-8502, Japan
Completed	Daido Clinic	Nagoya, 457-8511, Japan
Completed	Chubu Rosai Hospital	Nagoya, 455-8530, Japan
Completed	Nagoya City University Hospital	Nagoya, 467-8602, Japan
Completed	Osaka Rosai Hospital	Sakai, 591-8025, Japan
Completed	Kobe University Hospital	Kobe, 650-0017, Japan
Completed	Hyogo Prefectural Nishinomiya Hospital	Nishinomiya, 662-0918, Japan
Completed	Nara Prefecture General Medical Center	Nara, 630-8581, Japan
Completed	Kawasaki Medical School Hospital	Kurashiki, 701-0192, Japan
Completed	Kokura Memorial Hospital	Kitakyushu, 802-8555, Japan
Completed	JCHO Kyushu Hospital	Kitakyushu, 806-8501, Japan
Completed	Fukuoka University Hospital	Fukuoka, 814-0180, Japan
Completed	Aso Iizuka Hospital	Iizuka, 820-8505, Japan
Completed	Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital	Fukuoka, 811-0213, Japan
Completed	Saga-Ken Medical Centre Koseikan	Saga, 840-8571, Japan
Completed	Japanese Red Cross Kumamoto Hospital	Kumamoto, 861-8520, Japan
Completed	SINACOR \| Culiacan, Mexico	Culiacán, 80230, Mexico
Completed	Sitio Alfredo Chew Wong \| Aguascalientes, Mexico	Aguascalientes, 20124, Mexico
Completed	Sociedad de Metabolismo y Corazon S.C. \| Veracruz, Mexico	Puerto de Veracruz, 91900, Mexico
Active, not recruiting	Fundacion Cardiovascular de Aguascalientes \| Aguascalientes, Mexico	MISSING, 20230, Mexico
Completed	Nefromed s.r.o.	Praha 6, 160 00, Czech Republic
Completed	Nemocnice Znojmo	Znojmo, 669 02, Czech Republic
Completed	Rabin Medical Center \| Beilinson Hospital - Internal Medicine C Department	Petach Tikva, 4941492, Israel
Completed	Health Corporation of Galilee Medical Center	Nahariya, 2210001, Israel
Completed	Clalit Health \| Soroka Medical Center - Internal Medicine Department	Beer Sheva, 8410101, Israel
Completed	Chaim Sheba Medical Center	Ramat Gan, 5262000, Israel
Completed	Assuta Ashdod Public Hospital (R.A)	Ashdod, 7747629, Israel
Completed	Kaplan Medical Center	Rehovot, 7610001, Israel
Completed	Shamir Medical Center (Assaf Harofeh)	Zerifin, 7030000, Israel
Completed	Rambam Health Corporation	Haifa, 3109601, Israel
Completed	Poria Medical Center \| Nephrology and Hypertension Department	Tiberias, 1528001, Israel
Completed	Eastern Health Integrated Renal Service	Box Hill, 3128, Australia
Completed	Sunshine Hospital	St Albans, 3021, Australia
Completed	Concord Repatriation General Hospital	Concord, 2139, Australia
Completed	St George Hospital	Kogarah, 2217, Australia
Completed	Illawarra Shoalhaven Local Health District	Wollongong, 2500, Australia
Completed	Instituto de Investigaciones Clinicas de Mar del Plata \| Mar del Plata, Argentina	Mar del Plata, B7600FZ0, Argentina
Completed	Centro de Investigaciones Clinicas del Litoral \| Santa Fe, Argentina	Santa Fe, S3000FWO, Argentina
Completed	Asociacion de Fomento y Sala de Primeros Auxilios Alberto Mignaburu \| Berazategui, Argentina	Berazategui, B1837, Argentina
Completed	Centro de Investigaciones Metabolicas \| Ciudad de Autonoma de Buenos Aires, Argentina	Ciudad Autónoma de Buenos Aire, C1056ABI, Argentina
Recruiting	Clinica de Nefrologia Urologia y Enfermedades Cardiovascular	Santa Fe, 3000, Argentina
Recruiting	Clinica Privada Velez Sarsfield	Córdoba, X5016KET, Argentina
Completed	Saratov City Clinical Hospital #9	Saratov, 410030, Russia
Completed	City Clinical Hospital of Emergency Care #1	Omsk, 644112, Russia
Completed	Regional Clinical Hospital Yaroslavl	Yaroslavl, 150062, Russia
Completed	City Hospital #52	Moscow, 123182, Russia
Not yet recruiting	City clinical hospital #40 Sestroretsk	Sestroretsk, 197706, Russia
Not yet recruiting	City clinical hospital n.a. V.V. Vinogradov	Moscow, 117292, Russia
Completed	Kemerovo Regional Clinical Hospital	Kemerovo, 650066, Russia
Withdrawn	Perm Regional Hospital for War Veterans	Perm, 614097, Russian Federation
Withdrawn	1st Moscow State Medical University n.a. I.M.Sechenov	Moscow, 119991, Russian Federation
Completed	Voronezh Regional Clinical Consultancy-Diagnostic Center	Voronezh, 394018, Russia
Completed	Izhevsk City Clinical Hospital #9	Izhevsk, 426063, Russia
Not yet recruiting	First City Clinical Hospital n.a. E.E. Volosevich	Arkhangelsk, 163001, Russia
Completed	Rostov State Medical University	Rostov-on-Don, 344022, Russia
Completed	Limited liability company "MK-Med"	Saint-Petersburg, 197082, Russia
Withdrawn	Chelyabinsk City Clinical Hospital ¿6	Chelyabinsk, 454017, Russian Federation
Completed	Chinese PLA General Hospital	Beijing, 100853, China
Completed	The First Affiliated Hospital of Guangzhou University of TCM	Guangzhou, 510405, China
Completed	Central Hospital of Minhang District, Shanghai	Shanghai, 201199, China
Completed	Zhongda Hospital Southeast University	Nanjing, 210009, China
Completed	Jiangsu Province Hospital of Chinese Medicine	Nanjing, 210029, China
Completed	Daping Hospital, 3rd Affil Hosp. 3rd Military Med Univ PLA	Chongqing, 400042, China
Completed	Sichuan University West China Hospital	Chengdu, MISSING, China
Completed	The First Affiliated Hospital of Baotou Medical College	Baotou, 14010, China
Completed	Huai'an First People's Hospital, Nanjing Medical University	Huai'An, 223300, China
Completed	Shanghai Fifth People's Hospital,Fudan University	Shanghai, 200240, China
Completed	The Second Hospital of Anhui medical university	Hefei, 230601, China
Completed	The Second Hospital of Jilin University	Changchun, 130000, China
Completed	Siping Central Hospital	Siping, MISSING, China
Completed	Xinhua Hos Affiliated to SH Jiaotong Uni School of Medicine	Shanghai, 200092, China
Completed	Hwa Mei Hospital, University of Chinese Academy Sciences	Ningbo, 31510, China
Completed	SichuanAcademyofMedicalSciences&SichuanProvincialPeople'sHos	Chengdu, 610072, China
Completed	General Hospital of Ningxia Medical University	Yinchuan, 750004, China
Completed	The First Affiliated Hospital of Dalian Medical University	Dalian, 116011, China
Completed	The First Affiliated Hospital of Xinjiang Medical University	Urumqi, 830011, China
Completed	The Affiliated Hospital of Guizhou Medical University	Guiyang, 550004, China
Completed	The First Affiliated Hospital of Xiamen University	Xiamen, 361003, China
Completed	The First Affiliated Hospital of NanChang University	Nanchang, 330006, China
Completed	Puai Hospital,Tongji Medical College, Huazhong Univ Sci&Tech	Wuhan, 430034, China
Completed	Wuhan Hospital Of Traditional Chinese And Western Medicine	Wuhan, 430022, China
Recruiting	Zhujiang Hospital of Southern Medical University	Guangzhou, 510280, China
Completed	Beijing Anzhen Hospital, Capital Medical University	Beijing, 100029, China
Completed	Beijing Tsinghua Changgung Hospital	Beijing, 102218, China
Completed	Renmin Hosp., Wuhan Univ.	Wuhan, 430040, China
Completed	The First Affiliated Hospital of Jinan University	Guangzhou, 510630, China
Completed	Jiangxi PingXiang people's Hospital	Pingxiang, 337055, China
Completed	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an, 710061, China
Completed	The First Affiliated Hospital of Wenzhou Medical Univ (New)	Wenzhou, 325000, China
Completed	Lanzhou University Second Hospital	Lanzhou, 730030, China
Completed	The First Affiliated Hospital of Bengbu Medical College	Bengbu, MISSING, China
Completed	Zhongshan Hospital, Fudan University - Oncology Department	Shanghai, 200032, China
Withdrawn	Taizhou People's Hospital	Taizhou, 225317, China
Completed	1st Peopl's Hosp of Changzhou 3rd Affil Hosp of Soochow Univ	Changzhou, 213003, China
Completed	Tianjin Union Medicine Centre (People's Hospital of Tianjin)	Tianjin, 300121, China
Completed	China-Japan Friendship Hospital	Beijing, 100029, China
Completed	Severance Hospital, Yonsei University Health System - Cardiology	Seoul, 03722, Korea,_republic_of
Completed	Ansan Hospital \| Nephrology	Gyeonggi-do, 425-707, Korea,_republic_of
Completed	CHA Bundang Medical Center \| Nephrology	Seongnam-si, 13496, Korea,_republic_of
Completed	Kangnam Sacred Heart Hospital	Seoul, 7441, Korea,_republic_of
Completed	Far Eastern Memorial Hospital \| Nephrology Department	New Taipei City, 220, Taiwan
Completed	Chang Gung Memorial Hospital at Linkou	Taoyuan, 33305, Taiwan
Completed	National Taiwan University Hospital	Taipei, 100, Taiwan
Completed	Chang Gung Memorial Hospital Kaohsiung	Kaohsiung, 833, Taiwan
Completed	Taichung Veterans General Hospital	Taichung, 40705, Taiwan
Completed	Changhua Christian Hospital	Changhua, 50006, Taiwan
Completed	China Medical University Hospital	Taichung, 404327, Taiwan
Completed	Queen Mary Hospital	Hong Kong, 00000, Hong Kong
Completed	Prince of Wales Hospital	Hong Kong, 00000, Hong Kong
Completed	Princess Margaret Hospital	Hong Kong, 00000, Hong Kong
Completed	Kanazawa University Hospital	Kanazawa, 920-8641, Japan
Withdrawn	Foshan First People's Hospital	Foshan, 528000, China
Completed	Tung Wah Hospital	Sheung Wan, 00000, Hong Kong
Completed	Hospital Kuala Lumpur	Kuala Lumpur, 50586, Malaysia
Completed	Noble Hospital	Hadapsar, 411013, India
Completed	All India Institute of Medical Sciences	Bhubaneswar, 751019, India
Completed	Max Super Speciality Hospital, Saket	New Delhi, 110017, India
Completed	Institute of Post-Graduate Medical Education and Research	Kolkata, 700020, India
Completed	Azienda Socio Sanitaria Territoriale Ovest Milanese_Legnano - Nefrologia e Dialisi	Legnano, 20025, Italy
Completed	Huizhou Central People's Hospital	Huizhou, 516001, China
Recruiting	Kangdong Sacred Heart Hospital	Teugbyeolsi, 134-701, Korea, Republic Of
Not yet recruiting	Fakultni nemocnice Ostrava	Ostrava, 708 52, Czech Republic
Completed	Inje University Busan Paik Hospital	Busan, 47392, Korea,_republic_of
Completed	The Catholic Univ. of Korea Eunpyeong St. Mary's Hospital	Seoul, 03312, Korea,_republic_of
Completed	Singapore General Hospital	Singapore, 169608, Singapore
Completed	Ippokratio General Hospital Of Thessaloniki- 1st Department of Nephrology	Thessaloniki, 54642, Greece
Completed	Khoo Teck Puat Hospital	Singapore, 768828, Singapore
Completed	Tan Tock Seng Hospital	Singapore, 308433, Singapore
Completed	National University Hospital Medical Centre	Singapore, 119074, Singapore
Withdrawn	People's Friendship University of Russia	Moscow, 129327, Russian Federation
Withdrawn	Kazan State Medical University	Kazan, 420029, Russian Federation
Withdrawn	Pandy Kalman Korhaz	Gyula, 5700, Hungary
Completed	Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz	Szombathely, 9700, Hungary
Completed	Nagykanizsai Kanizsai Dorottya Korhaz	Nagykanizsa, 8800, Hungary
Not yet recruiting	Del-pesti Centrumkorhaz – Orszagos Hematologiai és Infektologiai Intezet	Budapest, 1097, Hungary
Completed	Pecsi Tudomanyegyetem Klinikai Kozpont	Pecs, 7624, Hungary
Completed	Medifarma-98 Egeszsegugyi, Kereskedelmi es Szolgaltato Kft.	Nyiregyhaza, 4400, Hungary
Completed	Somogy Varmegyei Kaposi Mor Oktato Korhaz	Kaposvar, 7400, Hungary
Completed	Tel-Aviv Sourasky Medical Center	Tel Aviv, 6423906, Israel
Completed	Princess Alexandra Hospital Australia	Woolloongabba, 4102, Australia
Completed	University General Hospital of Heraklion-Nephrology Clinic	Heraklion, 71500, Greece
Completed	University General Hospital Of Ioannina-Nephrology Clinic	Ioannina, 45500, Greece
Completed	SingHealth Polyclinics - Pasir Ris	Singapore, 519457, Singapore
Completed	Shree Siddhivinayak Maternity & Nursing Home	Nashik, 422002, India
Completed	Hospital Tuanku Jaafar \| Nephrology Department	Negeri Sembilan, 70300, Malaysia
Recruiting	Centro de Investigación y Prevención Cardiovascular	Buenos Aires, C1061AAS, Argentina
Withdrawn	Core Research Group Pty Ltd \| Brisbane, Australia	Taringa QLD, 4068, Australia
Completed	Centro de Investigaciones Medicas Lanus \| Buenos Aires, Argentina	Lanus, B1824, Argentina
Completed	Medical Center Zara-Med EOOD \| Nephrology Department	Stara Zagora, 6010, Bulgaria
Completed	Viva Phoenix Medical Center \| Clinical Trials Department	Dobrich, 9300, Bulgaria
Completed	Sunshine Coast University Hospital	Birtinya, 4575, Australia
Completed	Unidade Local De Saúde De Lisboa Ocidental E.P.E.	Carnaxide, 2790-134, Portugal
Completed	Unidade Local de Saude Almada-Seixal \| Hospital Garcia de Orta - Research Department	Almada, 2805-267, Portugal
Completed	Centro Hospitalar de Leiria \| Santo Andre Hospital - Research Center	Leiria, 2410-197, Portugal
Completed	Centro Hospitalar do Medio Tejo \| Unidade de Torres Novas - Nephrology Department	Torres Novas, 2350-754, Portugal
Completed	Centro Hospitalar Universitario de Lisboa Central \| Hospital Curry Cabral - Nephrology Department	Lisboa, 1069-166, Portugal
Completed	Azienda Socio Sanitaria Territoriale Rhodense	Rho, 20017, Italy
Completed	Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Nefrologia	Roma, 00168, Italy
Completed	Barts Health NHS Trust - Royal London Hospital - Nephrology	London, E1 1BB, United Kingdom
Completed	Cardiff and Vale University Health Board \| University Hospital of Wales - Nephrology and Transplant	Cardiff, CF14 4XW, United Kingdom
Completed	King’s College Hospital NHS Foundation Trust \| King's College Hospital - Nephrology Department	London, SE5 9RS, United Kingdom
Completed	Kent and Canterbury Hospital \| Renal Research Delivery Team	Canterbury, CT1 3NG, United Kingdom
Completed	Gloucestershire Hospitals NHS Foundation Trust \| Gloucestershire Royal Hospital - Nephrology	Gloucester, GL1 3NN, United Kingdom
Completed	The First affiliated Hospital of Hebei North University	Zhangjiakou, 075000, China
Completed	Qilu Hosp., Shandong Univ.	Jinan, 250000, China
Completed	Sheffield Teaching Hospitals NHS Foundation Trust \| Northern General Hospital - NIHR Sheffield Clinical Research Facility	Sheffield, S5 7AU, United Kingdom
Completed	UZ Gent	GENT, 9000, Belgium
Completed	CU Saint-Luc/UZ St-Luc	BRUXELLES - BRUSSEL, 1200, Belgium
Withdrawn	UZ Antwerpen - Nephrology	Edegem, 2650, Belgium
Completed	AZ Groeninge Campus Kennedylaan \| Nephrology	Kortrijk, 8500, Belgium
Completed	AZ Delta / Nephrology	Roeselare, 8800, Belgium
Completed	UZ Leuven Gasthuisberg	LEUVEN, 3000, Belgium
Completed	CHU de Liège	LIEGE, 4000, Belgium
Completed	Jiangmen Wuyi Hospital of traditional Chinese Medicine	Jiangmen, 529099, China
Not yet recruiting	The People's Hospital of Guangxi Zhuang Autonomous Region	Nanning, 530021, China
Completed	Nephrology Consultants, LLC	Huntsville, 35805, United States
Completed	Nephrology Associates of Northern Illinois and Indiana - Hinsdale	Hinsdale, 60521, United States
Not yet recruiting	Frenova Renal Research \| Boise Kidney and Hypertension	Meridian, 83642, United States
Completed	Hospital Kajang	Selangor, 43000, Malaysia
Completed	Gamma Medical Research, Inc.	McAllen, 78503, United States
Terminated	St. Louis Heart and Vascular, PC - Christian Hospital Office	Saint Louis, 63136, United States
Completed	Research Physicians Network Alliance	Boca Raton, 33431, United States
Completed	Dallas Renal Group - Medical City	Dallas, 75230, United States
Completed	Hospital del Mar \| Nephrology Department	Barcelona, 08003, Spain
Completed	Hospital Publico Da Marina \| Nefrologia	Burela, 27880, Spain
Completed	United Clinical Research & Innovations	South Gate, 90280, United States
Completed	Wichita Nephrology Group, PA	Wichita, 67214, United States
Completed	People's Hospital of Liuzhou City	Liuzhou, 545006, China
Completed	Liuzhou Worker's Hospital	Liuzhou, 545005, China
Completed	Privamed s.r.o.	Plzen, 323 33, Czech Republic
Completed	Koshigaya Municipal Hospital	Koshigaya, 343-8577, Japan
Completed	Kistarcsai Flor Ferenc Korhaz	Kistarcsa, 2143, Hungary
Completed	Hospital Pakar Sultanah Fatimah	Muar, 84000, Malaysia
Completed	AdventHealth Translational Research Institute	Orlando, 32804, United States
Completed	Madras Medical College	Chennai, 600003, India
Completed	Government Medical College Thiruvananthapuram	Thiruvananthapuram, 695011, India
Completed	National Taiwan University Hospital, Hsin-Chu Branch	Hsin-Chu, 300, Taiwan
Completed	Fakultní nemocnice Brno - Interní gastroenterologická klinika	Brno, 625 00, Czech Republic
Completed	Mavani Research Center	Ahmedabad, 380052, India

Primary Outcome

Mean rate of change as measured by the total slope of eGFR from baseline to Month-32.
eGFR: Estimated glomerular filtration rate
Time Frame:
From baseline to month 32

Secondary Outcome

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)
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)
Time to the composite to heart failure hospitalization or CV death
Time Frame:
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

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

N/A

Assignment

Parallel Assignment

Trial Arms

Additional Information

Click here to find further information and, after study completion, the study results according to Bayer's transparency standards