Trial Condition(s):
A trial to learn how well finerenone works and how safe it is in adult participants with non-diabetic chronic kidney disease (FIND-CKD)
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Not Available
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.
- 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
- 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)
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Locations Rostov State Medical University Rostov-on-Don, Russia, 344022 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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Locations Chinese PLA General Hospital Beijing, China, 100853 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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Locations Xinhua Hos Affiliated to SH Jiaotong Uni School of Medicine Shanghai, China, 200092 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hwa Mei Hospital, University of Chinese Academy Sciences Ningbo, China, 31510 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations SichuanAcademyofMedicalSciences&SichuanProvincialPeople'sHos Chengdu, China, 610072 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations General Hospital of Ningxia Medical University Yinchuan, China, 750004 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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Locations PingXiang People's Hospital Pingxiang, China, 337055 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The First Affiliated Hospital of Xi'an Jiaotong University Xi'an, China, 710061 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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Locations Lanzhou University Second Hospital Lanzhou, China, 730030 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The First Affiliated Hospital of Bengbu Medical College Bengbu, China, 233099 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Zhongshan Hospital, Fudan University Shanghai, China, 200032 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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Locations Tianjin Union Medicine Centre (People's Hospital of Tianjin) Tianjin, China, 300121 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations China-Japan Friendship Hospital Beijing, China, 100029 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Severance Hospital, Yonsei University Health System Seoul, South Korea, 03722 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Korea University Ansan Hospital Gyeonggi-do, South Korea, 425-707 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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Locations Kangnam Sacred Heart Hospital Seoul, South Korea, 07441 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Far Eastern Memorial Hospital | Nephrology Department New Taipei City, Taiwan, China, 220 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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Locations Chang Gung Memorial Hospital Kaohsiung Kaohsiung, Taiwan, China, 833 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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Locations Kanazawa University Hospital Kanazawa, Japan, 920-8641 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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Locations ASST Ovest Milanese Milano, Italy, 20025 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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Locations Kangdong Sacred Heart Hospital Teugbyeolsi, South Korea, 134-701 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Inje University Busan Paik Hospital Busan, South Korea, 47392 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The Catholic Univ. of Korea Eunpyeong St. Mary's Hospital Seoul, South Korea, 03312 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Singapore General Hospital Singapore, Singapore, 169608 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hippokration General Hospital of Thessaloniki Thessaloniki, Greece, 54642 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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Locations National University Hospital Singapore, Singapore, 119074 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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Locations Kanizsai Dorottya Hospital Nagykanizsa, Hungary, 8800 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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Locations Tel-Aviv Sourasky Medical Center Tel Aviv, Israel, 6423906 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Princess Alexandra Hospital Australia Woolloongabba, Australia, 4102 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University General Hospital of Heraklion Heraklion, Greece, 711 10 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ioannina University General Hospital Ioannina, Greece, 45500 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations SingHealth Polyclinics - Pasir Ris Singapore, Singapore, 519457 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Shree Siddhivinayak Maternity & Nursing Home Nashik, India, 422002 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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Locations Centro de Investigación y Prevención Cardiovascular Buenos Aires, Argentina, C1061AAS | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro de Investigaciones Medicas Lanus | Research Department Lanus, Argentina, B1824 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MC Zara - Med/ Nephrological office Stara Zagora, Bulgaria, 6010 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Viva Phoenix Medical Center | Clinical Trials Department Dobrich, Bulgaria, 9300 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sunshine Coast University Hospital Birtinya, Australia, 4575 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro Hospitalar de Lisboa Ocidental | Clin Res Dept Carnaxide, Portugal, 2790-134 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Garcia de Orta | Research Department Almada, Portugal, 2801-951 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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Locations Centro Hospitalar do Medio Tejo | Unidade de Torres Novas - Nephrology Department Torres Novas, Portugal, 2350-754 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro Hospitalar Universitario de Lisboa Central | Hospital Curry Cabral - Nephrology Department Lisboa, Portugal, 1069-166 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ASST Rhodense Milano, Italy, 20024 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fondazione Policlinico Universitario Agostino Gemelli IRCCS Roma, Italy, 00168 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Royal London Hospital London, United Kingdom, E1 1BB | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University Hospital of Wales Cardiff, United Kingdom, CF14 4XW | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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Locations The First affiliated Hospital of Hebei North University Zhangjiakou, China, 075000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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Locations Northern General Hospital Sheffield, United Kingdom, S5 7AU | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UZ Gent GENT, Belgium, 9000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CU Saint-Luc/UZ St-Luc BRUXELLES - BRUSSEL, Belgium, 1200 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AZ Groeninge Campus Kennedylaan | Nephrology Kortrijk, Belgium, 8500 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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Locations Mavani Research Center Ahmedabad, India, 380052 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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:
2