Trial Condition(s):
Type 2 Diabetes Mellitus, Chronic Kidney Disease
A study to learn how well the treatment combination of finerenone and empagliflozin works and how safe it is compared to each treatment alone in adult participants with long-term kidney disease (chronic kidney disease) and type 2 diabetes (CONFIDENCE)
Bayer Identifier:
21839
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
2023-506981-30-00
Trial Purpose
Finerenone works by blocking a group of proteins, called mineralocorticoid receptor. An increased stimulation of mineralocorticoid receptor is known to trigger injury and inflammation in the kidney and is therefore thought to play a role in CKD.
Empagliflozin lowers blood sugar levels by increasing the excretion of glucose from the blood into the urine.
In this study, the researchers want to learn how well the combination of finerenone and empagliflozin helps to slow down the worsening of the participants’ kidney function compared to either treatment alone. For this, the level of protein in the urine will be measured. The investigators also want to know how safe the combination is compared to either treatment alone.
Depending on the treatment group, the participants will either take the combination of finerenone and empagliflozin, or finerenone together with a placebo, or empagliflozin together with a placebo, once a day as tablets by mouth. A placebo looks like a treatment but does not have any medicine in it. Importantly, the participants will also continue to take their other current medicine for CKD and T2D.
The participants will be in the study for up to 7.5 months and will take the study treatments for 6 months. During the study, participants will visit the study site 7 times.
The study team will:
• collect blood and urine samples
• check the participants’ vital signs
• do a physical examination including height and weight
• check the participants’ heart health by using an electrocardiogram (ECG)
• monitor the participants’ blood pressure
• ask the participants questions about how they are feeling and what adverse events they may be having
An adverse event is any problem that happens during the trial. Doctors keep track of all events that happen in trials, even if they do not think the events might be related to the study treatments.
Inclusion Criteria
- Participant with a clinical diagnosis of chronic kidney disease (CKD) and the following: -- In Part A: eGFR 40-90 ml/min/1.73m^2 (with no more than 20% having an eGFR >75 ml/min/1.73m^2) using Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) formula at screening visit and at least one historical value of eGFR <60 mL/min/1.73 m^2 within 3 months or have a registered diagnosis of CKD. -- In Part B: eGFR 30-90 ml/min/1.73m^2 (with no more than 20% having an eGFR >75 ml/min/1.73m^2) using CKD-EPI formula at screening visit and at least one historical value of eGFR <60 mL/min/1.73 m^2 within 3 months or have a registered diagnostic of CKD. -- 100 ≤UACR <5000 mg/g at screening visit (mean value from 3 morning void samples) and documentation of albuminuria/proteinuria (quantitative or semi-quantitative measurement) in the participant’s medical records at least 3 months prior to screening - Participant with type 2 diabetes (T2D) as defined by the American Diabetes Association (ADA 2021), with glycated hemoglobin (HbA1c) at screening <11%. - Participant treated with the clinically maximum tolerated dose, as per investigator judgment, of angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB), but not both, for more than 1 month at screening visit.
Exclusion Criteria
- Participants with type 1 diabetes (T1D). - Participant with hepatic insufficiency classified as Child-Pugh C. - Participant with blood pressure at Day 1 visit (Visit 2) higher than 160 systolic blood pressure (SBP) or 100 diastolic blood pressure (DBP) or SBP lower than 90 mmHg. - Participant currently treated with a sodium/glucose cotransporter-2 inhibitor (SGLT2i) or SGLT-1/2i or who received a SGLT2i or SGLT-1/2i which cannot be discontinued at least 8 weeks prior to the screening visit and during study intervention treatment. - Participant treated with another mineralocorticoid receptor antagonist (MRA) (e.g., eplerenone, esaxerenone, spironolactone, canrenone), a renin inhibitor, potassium supplements, a potassium sparing diuretic (e.g., amiloride, triamterene), a potassium binder agent, or angiotensin receptor-neprilysin inhibitor (ARNI) which cannot be discontinued at least 8 weeks prior to the screening visit and during study intervention treatment. - Participants currently treated or who were treated with Finerenone (Kerendia©) within 8 weeks prior to the screening visit. - Participant with serum/plasma potassium (K+) above 4.8 mmol/L at screening visit (central laboratory value).
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Many Locations Many Locations, Italy | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, Taiwan, China | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Velocity Clinical Research - Savannah Savannah, United States, 31406 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, Japan | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, France | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, Spain | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Diabetologische Schwerpunkt Praxis Dortmund Dortmund, Germany, 44137 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Zentrum für Diabetologie und Ernährungsmedizin Ludwigshafen, Germany, 67059 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations St. Josefskrankenhaus Heidelberg, Germany, 69115 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Diabetes Zentrum Wandsbek Hamburg, Germany, 22041 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Cardiologicum Pirna / Dresden-Seidnitz Pirna, Germany, 1796 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Charité Campus Benjamin Franklin (CBF) Berlin, Germany, 12203 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ClinPhenomics GmbH&Co. KG Frankfurt, Germany, 60596 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hopital Carémeau - Nîmes Nîmes, France, 30029 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Center Hospitalier Michallon - Grenoble GRENOBLE CEDEX 9, France, 38043 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital François Mitterrand - Dijon Dijon, France, 21000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital Edouard Herriot - Lyon Cedex LYON CEDEX, France, 69003 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital Saint Joseph PARIS, France, 75014 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Saiseikai Matsuyama Hospital Matsuyama, Japan, 791-8026 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Osaka General Medical Center Osaka, Japan, 558-8558 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medical Corporation Taifukukai, Osaka Nishiumeda Clinic Osaka, Japan, 530-0001 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fukuoka University Chikushi Hospital Chikushino, Japan, 818-8502 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Japanese Red Cross Kumamoto Hospital Kumamoto, Japan, 861-8520 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Naka Kinen Clinic Naka-shi, Japan, 311-0113 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kokura Memorial Hospital Kitakyushu, Japan, 802-8555 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hirohata Naika Clinic Kitakyushu, Japan, 807-0857 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fukui-ken Saiseikai Hospital Fukui, Japan, 918-8503 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital Fukuoka, Japan, 811-0213 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ospedale San Raffaele s.r.l. - Medicina Generale Indirizzo Diabetologico ed Endocrino-Metabolico Milano, Italy, 20132 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Azienda Socio Sanitaria Locale N 2 Della Gallura - Diabetologia Olbia, Italy, 07026 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - Malattie Endocrine e Diabetologia Bergamo, Italy, 24127 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Azienda Socio Sanitaria Territoriale Santi Paolo e Carlo_Ospedale S. Paolo - Gestione integrata della malattia Diabetica Milano, Italy, 20142 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Azienda Ospedaliera Universitaria Integrata Verona_Borgo Roma - Endocrinologia, Diabetologia e Malattie del Metabolismo Verona, Italy, 37134 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ASL 4 Chiavarese Chiavari, Italy, 16043 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Azienda Ospedaliero-Universitaria San Luigi Gonzaga - Malattie Metaboliche Diabetologia Orbassano, Italy, 10043 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Azienda Socio Sanitaria Territoriale Rhodense Rho, Italy, 20017 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Azienda Ospedaliero Universitaria Parma - SC Nefrologia Parma, Italy, 43126 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Quironsalud Barcelona | Internal Medicine Department Barcelona, Spain, 8023 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Gerencia de Gestion Integrada A Coruna | Department of Endocrinology and Nutrition A Coruna, Spain, 15006 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario Virgen de las Nieves | Servicio de Endocrinologia y Nutricion Granada, Spain, 18014 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Principe de Asturias Alcalá de Henares, Spain, 28805 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clínico Universitario de Valencia Valencia, Spain, 46010 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Complejo Hospitalario Universitario de Ferrol | Hospital Naval - Unidad de Hipertensión Arterial Ferrol, Spain, 15405 | 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 UZ Leuven Gasthuisberg LEUVEN, Belgium, 3000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Regionaal ZH Jan Yperman Campus Mariaziekenhuis IEPER, Belgium, 8900 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AZ Groeninge Campus Kennedylaan Kortrijk, Belgium, 8500 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AZ Delta ROESELARE, Belgium, 8800 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHU de Charleroi Hôpital civil Lodelinsart, Belgium, 6042 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AZ St-Lucas Campus St-Lucas gent, Belgium, 9000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Albert Schweitzer Ziekenhuis | Dordwijk - Cardiology Department DORDRECHT, Netherlands, 3318 AT | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Gelre Ziekenhuizen APELDOORN, Netherlands, 7334 DZ | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Meander Medisch Centrum AMERSFOORT, Netherlands, 3818 TZ | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Onze Lieve Vrouwe Gasthuis AMSTERDAM, Netherlands, 1091 AC | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Region Midtjylland | Regionshospitalet Godstrup - Nephrology Department Herning, Denmark, DK-7400 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Steno Diabetes Center Copenhagen | Herlev - Clinical and Translational Research Department Herlev, Denmark, 2730 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Bispebjerg Hospital - Hjerteafdeling København, Denmark, DK-2400 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital of South West Jutland | Department of Endocrinology Research Esbjerg, Denmark, 6700 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Health Corporation of the Ziv Medical Center (R.A.) Zefat, Israel, 1311001 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Barzilai Medical Center | Department of Nephrology and Hypertension Ashkelon, Israel, 7830604 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Health Corporation of Galilee Medical Center Nahariya, Israel, 2210001 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations HaEmek Medical Center | Internal Medicine C Department - Research Unit Afula, Israel, 1834111 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Rabin Medical Center | Beilinson Hospital - Internal Medicine C Department Petach Tikva, Israel, 4941492 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Edith Wolfson Medical Center | Internal Medicine Department Holon, Israel, 58100 | 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 |
Locations Changhua Christian Hospital Changhua, Taiwan, China, 50006 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Chang Gung Memorial Hospital Kaohsiung Kaohsiung, Taiwan, China, 833 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Taipei Medical University - Shuang Ho Hospital New Taipei City, Taiwan, China, 23561 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Taipei Veterans General Hospital Taipei, Taiwan, China, 11217 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Taichung Veterans General Hospital Taichung, Taiwan, China, 40705 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations China Medical University Hospital Taichung, Taiwan, China, 404327 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Friedrich-Schiller-Uni. Jena Jena, Germany, 07747 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinical Research Consultants Kansas City, United States, 64111 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Office of Osvaldo A. Brusco, MD Corpus Christi, United States, 78414-4173 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Academic Medical Research Institute Los Angeles, United States, 90022 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kansas City VA Medical Center Kansas City, United States, 64128 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Meridian Clinical Research- Norfolk Norfolk, United States, 68701 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations DaVita Clinical Research- El Paso El Paso, United States, 79925 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Circuit Clinical/Crystal Run Middletown, United States, 10941 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Salem VA Medical Center - Endocrinology Salem, United States, 24153 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Tennessee Health Science Center Memphis, United States, 38163 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Randolph Medical Associates Asheboro, United States, 27203 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinical Advancement Center, PLLC San Antonio, United States, 78212 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Velocity Clinical Research, Cincinnati Cincinnati, United States, 45242 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations St. Louis Heart & Vascular, PC Saint Louis, United States, 63136 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Eastern Nephrology Associates - Greenville West Greenville, United States, 27834 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Washington University School of Medicine in St. Louis Saint Louis, United States, 63110-1010 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Chase Medical Research, LLC Waterbury, United States, 06708 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Somnos Clinical Research Lincoln, United States, 68510 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Omega Clinical Research Center Metairie, United States, 70006 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Grady Memorial Hospital - Endocrinology Atlanta, United States, 30303 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Olympus Family Medicine Salt Lake City, United States, 84117 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Eastern Nephrology Associates - Kinston Kinston, United States, 28504 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Healor Primary Care / CCT Research Las Vegas, United States, 89102 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Versailles Family Medicine Versailles, United States, 40383 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of North Carolina Kidney Center Chapel Hill, United States, 27599-7155 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Casa Sollievo della Sofferenza - Endocrinologia San Giovanni Rotondo, Italy, 71013 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Azienda Ospedaliero Universitaria Pisana_Cisanello - Malattie Metaboliche e Diabetologia Pisa, Italy, 56124 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hamilton Medical Research Group Hamilton, Canada, L8M 1K7 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sameh Fikry Professional Corporation Waterloo, Canada, N2J 1C4 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Recherche GCP Research Montreal, Canada, H2R 1V6 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations LMC Manna Research - Calgary Calgary, Canada, T2H 2G4 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Hospitalier de l’Université de Montréal (CHUM) Montreal, Canada, H2X 3E4 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Bluewater Clinical Research Group Sarnia, Canada, N7T 4X3 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations LMC Clinical Research Inc. Montreal Ville Saint-Laurent, Canada, H4T 1Z9 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Severance Hospital, Yonsei University Health System Seoul, Unmapped, 03722 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Asan Medical Center Seoul, Unmapped, 05505 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Yonsei University Wonju Christian Hospital Wonju, Unmapped, 26426 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hallym University Sacred Heart Hospital Anyang-si, Unmapped, 14068 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Chung Nam National University Hospital Daejeon, Unmapped, 35015 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Seoul National University Hospital Seoul, Unmapped, 3080 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MultiCare Rockwood Clinic Diabetes & Endocrinology Center Spokane, United States, 99202 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Santa Rosa Medical Centers of Nevada / CCT Research Las Vegas, United States, 89119 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Biopharma Informatic - McAllen, TX McAllen, United States, 78503 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario Dr. Peset Valencia, Spain, 46017 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ciutat Sanitaria i Universitaria de la Vall d'Hebron Barcelona, Spain, 08035 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinical Research Solutions, Inc. Waterloo, Canada, N2T 0C1 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Blue Sky, MD/ Lamond Family Medicine Hendersonville, United States, 28792 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario Puerta de Hierro Majadahonda | Clinical Pharmacology Department Majadahonda, Spain, 28222 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Vithas Sevilla | Endocrinology Department Castilleja de la Cuesta, Spain, 41950 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario Virgen de la Victoria | Unidad de Investigacion Clinica - Endocrinology Department Malaga, Spain, 29010 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universidad Autonoma de Madrid (UAM) - Facultad de Medicina - Hospital Universitario Fundacion Jimenez Diaz (UAM-FJD) Madrid, Spain, 28040 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations H. Costa del Sol (Marbella) Marbella, Spain, 29603 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clinico San Carlos Madrid, Spain, 28040 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Eternal Heart Care Centre (EHCC) and Research Institute Jaipur, India, 302020 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Government Medical College Kozhikode, India, 673008 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vinaya Hospital and Research Centre (A Unit of KIMS) Mangalore, India, 575003 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sawami Man Singh (SMS) Medical College & Attached Hospitals Jaipur, India, 302017 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Krishna Institute Of Medical Science Secunderabad, India, 500003 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Manipal Hospital Mysore, India, 5570 015 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations K.L.E.S. Dr. Prabhakar Kore Hospital & Medical Research Centre Belgaum, India, 590010 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Institute of Post-Graduate Medical Education and Research Kolkata, India, 700020 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Lifepoint Multispecialty Hospital Pune, India, 411057 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Seth Gordhandas Sunderdas Medical College (GSMC) - King Edward Memorial (KEM) Hospital Mumbai, India, 400 012 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations G.S.V.M. Medical College Kanpur, India, 208002 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Dr. Bantwal's Clinic Bengaluru, India, 560076 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Bangalore Medical College & Research Institute Bengaluru, India, NA | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Mavani Dialysis & Kidney Center Ahmedabad, India, NA | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sriram Chandra Bhanj Medical College & Hospital Cuttack, India, NA | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vedanta Kidney Care Vadodara, India, NA | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Government Kilpauk Medical College Hospital Chennai, India, NA | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Indraprastha Apollo Hospital New Delhi, India, 110076 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Osmania General Hospital Telangana, India, 500012 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Government Medical College and Hospital (GMCH) Nagpur Nagpur, India, 440009 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Grant Medical Foundation - Ruby Hall Clinic (RHC) Pune, India, 411001 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations King George Hospital Visakhapatnam, India, NA | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Asian Kidney Hospital and Medical Centre Nagapur, India, 440010 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nizam's Institute of Medical Sciences (NIMS) Hyderabad, India, 500082 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Dunes Clinical Research LLC Dakota Dunes, United States, 57049 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations DarSalud Care / LifeDOC Research Memphis, United States, 38119 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations West Orange Endocrinology & Clinical Research Ocoee, United States, 34761-4547 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Innovative Research Institute Port Charlotte, United States, 33952 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Victorium Clinical Research Houston, United States, 77024-2593 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations South Shore Nephrology Plymouth, United States, 02360 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Global Kidney Center Houston, United States, 77008 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Oakland Medical Center Dakota Dunes, United States, 48085 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nola Care Clinical Research Metairie, United States, 70006 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Thyroid, Endocrinology, and Diabetes (TED) PA Dallas, United States, 75208-2362 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Lake Michigan Nephrology Saint Joseph, United States, 49085 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations North Texas Kidney Disease Associates, PLLC Lewisville, United States, 75057 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Florida Kidney Physicians - Delray Beach Nephrology Delray Beach, United States, 33445 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Southeast Kidney Associates East Point, United States, 30344 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Touro University California Vallejo, United States, 94592 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Northridge Hospital Northridge, United States, 91325 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Olive View - UCLA Medical Center Sylmar, United States, 91342-1437 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Southwest Kidney Institute, PLC Surprise, United States, 85374 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Metabolic Research Institute, Inc. West Palm Beach, United States, 33401-3430 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Texas Health Science Center San Antonio, United States, 78249 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Jiyugaoka Yamada Internal Medicine Clinic Obihiro, Japan, 080-0848 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Endocrinologia Milano, Italy, 20122 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Università degli Studi "G. D'Annunzio" di Chieti - Endocrinologia Chieti, Italy, 66100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations William Osler Health centre, Sakuara Medical Mississauga, Canada, L5H4K9 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Onze-Lieve-Vrouwziekenhuis (OLVZ) - Campus Aalst Aalst, Belgium, 9300 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clalit Health | Soroka Medical Center - Internal Medicine Department Beer Sheva, Israel, 8410101 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kyung Hee University Hospital at Gangdong Seoul, Unmapped, 5278 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Seoul National University Bundang Hospital Seongnam-si, Unmapped, 13620 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hanyang University Guri Hospital Guri-si, Unmapped, 471-701 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hallym University Kangnam Sacred Heart Hospital Seoul, Unmapped, 7442 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Korea University Ansan Hospital Gyeonggi-do, Unmapped, 425-707 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The Catholic University of Korea, Incheon St.Mary's Hospital Incheon, Unmapped, 21431 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Public Central Hospital of Matto Ishikawa | Clinical Trial Management Office Hakusan, Japan, 924-8588 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Soon Chun Hyang University Cheonan Hospital Cheonan, Unmapped, 31151 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hadassah University Medical Center (HUMC) Jerusalem, Israel, 911200 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Max Super Speciality Hospital (MSSH) - Saket New Delhi, India, 110017 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations All India Institute of Medical Sciences Bhubaneswar, India, 751019 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
A parallel-group treatment, Phase 2, double-blind, three-arm study to assess efficacy and safety of finerenone plus empagliflozin compared with either finerenone or empagliflozin alone in participants with chronic kidney disease and type 2 diabetes.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
3
Primary Outcome
- Relative change from baseline in UACR at 180 days in combination therapy group versus empagliflozin aloneUrinary albumin to-creatinine ratio (UACR)Timeframe: Up to 180 days
- Relative change from baseline in UACR at 180 days in combination therapy group versus finerenone aloneTimeframe: Up to 180 days
- Mean ratio of change from baseline to Day 180 in UACR for the combination therapy group, to empagliflozin aloneTimeframe: Upto 180 days
- Mean ratio of change from baseline to Day 180 in UACR for the combination therapy group, to finerenone aloneTimeframe: Up to 180 days
Secondary Outcome
- Relative change in UACR between end of treatment visit (Day 180) and 30 days after end of treatment visit (Day 210)Timeframe: Up to 210 days
- Relative change in UACR between 30 days after end of treatment visit (Day 210) and baseline (Day 1)Timeframe: Up to 210 days
- Relative change in UACR category (>30%, >40%, >50%) at 180 daysTimeframe: Up to 180 days
- Ratio of change from baseline in eGFR at 30 daysestimated glomerular filtration rate (eGRF)Timeframe: Up to 30 days
- eGFR decline greater than 30% at 30 days from baselineTimeframe: Up to 30 days
- Ratio of change in eGFR at 180 days and 210 days from Day 30Timeframe: Up to 210 days
- Proportion of participants with of acute kidney injury (AKI) eventsAKI is defined as any of the following: - An increase in serum creatinine by greater than or equal to 0.3 mg/dL within 48 hours; or - An increase in serum creatinine by greater than or equal to 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or - A urine volume less than 0.5 ml/kg/h for 6 hoursTimeframe: Up to 180 days
- Total number of AKI eventsTimeframe: Up to 180 days
- Proportion of participants with hyperkalemia events (moderate hyperkalemia [5.5 <K+ ≤6.0 mmol/L], severe hyperkalemia [K+ >6.0 mmol/L])serum/plasma potassium (k+)Timeframe: Up to 180 days
- Total number of hyperkalemia events (moderate hyperkalemia [5.5 <K+ ≤6.0 mmol/L], severe hyperkalemia [K+ >6.0 mmol/L])Timeframe: Up to 180 days
- Change from baseline in K+Timeframe: Up to 180 days
- Proportion of participants with severe hypoglycemia eventsSevere hypoglycemia is defined as glucose level of <3.0 mmol/L (<54 mg/dL).Timeframe: Up to 180 days
- Total number of events of severe hypoglycemia eventsTimeframe: Up to 180 days
- Proportion of participants with symptomatic hypotension eventsTimeframe: Up to 180 days
- Total number of symptomatic hypotension eventsTimeframe: Up to 180 days
- Proportion of participants with genital mycotic eventsTimeframe: Up to 180 days
- Total number of genital mycotic eventsTimeframe: Up to 180 days
- Proportion of participants with ketoacidosis eventsTimeframe: Up to 180 days
- Total number of ketoacidosis eventsTimeframe: Up to 180 days
- Proportion of participants with necrotizing fasciitis of the perineum eventsTimeframe: Up to 180 days
- Total number of necrotizing fasciitis of the perineum eventsTimeframe: Up to 180 days
- Proportion of participants with urosepsis and pyelonephritis eventsTimeframe: Up to 180 days
- Total number of urosepsis and pyelonephritis eventsTimeframe: Up to 180 days
Additional Information
Copyright © Bayer
Powered by
