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
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.
Inclusion Criteria:
A clinical diagnosis of chronic kidney disease and:
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:
Los Angeles, California 90095, United States
Chicago, Illinois 60611, United States
Hinsdale, Illinois 60521, United States
Shreveport, Louisiana 71101, United States
Albuquerque, New Mexico 87131, United States
Chapel Hill, North Carolina 27514, United States
Nashville, Tennessee 37232, United States
El Paso, Texas 79902, United States
Salt Lake City, Utah 84132, United States
Berazategui, Buenos Aires B1837, Argentina
Ciudad Autónoma de Buenos Aire, Buenos Aires C1056ABI, Argentina
Lanus, Buenos Aires B1824, Argentina
Mar del Plata, Buenos Aires B7600FZ0, Argentina
CABA, Ciudad Auton. de Buenos Aires C1018DES, Argentina
San Luis, San Luis Province D5700CGR, Argentina
Bruxelles - Brussel, 1200, Belgium
Pernik, Pernik Province 2300, Bulgaria
Stara Zagora, Stara Zagora Province 6010, Bulgaria
Gorna Oryahovitsa, Veliko Tarnovo Province 5100, Bulgaria
Thessaloniki, 54642, Greece
Thessaloniki, 57010, Greece
Telangana, Telangana 500012, India
Petah Tikva, 4941492, Israel
Naples, Campania 80131, Italy
Bologna, Emilia-Romagna 40138, Italy
Modena, Emilia-Romagna 41124, Italy
Reggio Emilia, Emilia-Romagna 42123, Italy
Rome, Lazio 00168, Italy
Desio, Lombardy 20832, Italy
Legnano, Lombardy 20025, Italy
Ranica, Lombardy 24020, Italy
Kanazawa, Ishikawa-ken 920-8650, Japan
Irima-gun, Saitama 350-0495, Japan
Bunkyo-ku, Tokyo 113-8431, Japan
Bunkyo-ku, Tokyo 113-8655, Japan
Itabashi-ku, Tokyo 173-8610, Japan
Shinjuku-ku, Tokyo 160-0023, Japan
Kedah, 8000, Malaysia
Negeri Sembilan, 70300, Malaysia
Missing, Aguascalientes 20230, Mexico
Puerto de Veracruz, Veracruz 91900, Mexico
Torres Novas, Santarém District 2350-754, Portugal
Almada, Setúbal District 2805-267, Portugal
Lisbon, 1069-166, Portugal
Incheon, Incheon Gwang''yeogsi 21431, South Korea
Teugbyeolsi, Seoul 134-701, South Korea
Seoul, Seoul Teugbyeolsi 03312, South Korea
Seoul, Seoul Teugbyeolsi 03722, South Korea
London, Greater London E1 1BB, United Kingdom
London, Greater London SE5 9RS, United Kingdom
Sheffield, South Yorkshire S5 7AU, United Kingdom
Cardiff, Wales CF14 4XW, United Kingdom