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:
Not Available
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. -- 300 ≤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 higher than 160/100 or systolic blood pressure 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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Many Locations Many Locations, Italy | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, Taiwan, China | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Meridian Clinical Research- Savannah Savannah, United States, 31406 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, Japan | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, France | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, Spain | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Diabetologische Schwerpunkt Praxis Dortmund Dortmund, Germany, 44137 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Zentrum für Diabetologie und Ernährungsmedizin Ludwigshafen, Germany, 67059 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations St. Josefskrankenhaus Heidelberg, Germany, 69115 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Diabetes Zentrum Wandsbek Hamburg, Germany, 22041 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Cardiologicum Pirna / Dresden-Seidnitz Pirna, Germany, 01796 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Charité Campus Benjamin Franklin (CBF) Berlin, Germany, 12203 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ClinPhenomics GmbH&Co. KG Frankfurt, Germany, 60596 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hopital Carémeau - Nîmes NIMES cedex 9, France, 30029 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Center Hospitalier Michallon - Grenoble LA TRONCHE, France, 38700 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital François Mitterrand - Dijon Dijon, France, 21000 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hopital Carémeau - Nîmes NIMES cedex 9, France, 30029 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital Edouard Herriot - Lyon Cedex LYON CEDEX, France, 69437 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital Saint Joseph PARIS, France, 75014 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Saiseikai Matsuyama Hospital Matsuyama, Japan, 791-8026 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Osaka General Medical Center Osaka, Japan, 558-8558 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kyosokai AMC NISHI-UMEDA Clinic Osaka, Japan, 530-0001 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fukuoka University Chikushi Hospital Chikushino, Japan, 818-8502 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Japanese Red Cross Kumamoto Hospital Kumamoto, Japan, 861-8520 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nakakinen Clinic Naka, Japan, 311-0113 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kokura Memorial Hospital Kitakyushu, Japan, 802-8555 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hirohata Naika Clinic Kitakyushu, Japan, 807-0857 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fukui-ken Saiseikai Hospital Fukui, Japan, 918-8503 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fukuoka Wajiro Hospital Fukuoka, Japan, 811-0213 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ospedale San Raffaele s.r.l. Milano, Italy, 20132 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ATS Sardegna - ASSL Olbia Sassari, Italy, 07026 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ASST Papa Giovanni XXIII Bergamo, Italy, 24127 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ASST Santi Paolo e Carlo Milano, Italy, 20142 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U.I. Verona Verona, Italy, 37126 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ASL 4 Chiavarese Genova, Italy, 16043 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. San Luigi Gonzaga Torino, Italy, 10043 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ASST Rhodense Milano, Italy, 20024 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. di Parma Parma, Italy, 43126 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Quironsalud Barcelona | Internal Medicine Department Barcelona, Spain, 8023 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario 12 de Octubre Madrid, Spain, 28041 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Complejo Hospitalario Universitario A Coruña A Coruña, Spain, 15006 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario Virgen de las Nieves Granada, Spain, 18012 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Principe de Asturias Alcalá de Henares, Spain, 28805 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clínico Universitario de Santiago de Compostela Santiago de Compostela, Spain, 15706 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clínico Universitario de Valencia Valencia, Spain, 46010 | Status Recruiting | 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 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UZ Gent GENT, Belgium, 9000 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UZ Leuven Gasthuisberg LEUVEN, Belgium, 3000 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Regionaal ZH Jan Yperman Campus Mariaziekenhuis IEPER, Belgium, 8900 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AZ Groeninge Campus Kennedylaan Kortrijk, Belgium, 8500 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AZ Delta ROESELARE, Belgium, 8800 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHU de Charleroi Hôpital civil Lodelinsart, Belgium, 6042 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AZ St-Lucas Campus St-Lucas GENT, Belgium, 9000 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Albert Schweitzer Ziekenhuis, Dordwijk DORDRECHT, Netherlands, 3318 AT | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Academisch Medisch Centrum (AMC) AMSTERDAM, Netherlands, 1105 AZ | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Gelre Ziekenhuizen APELDOORN, Netherlands, 7334 DZ | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Meander Medisch Centrum AMERSFOORT, Netherlands, 3818 TZ | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations OLVG - locatie Oost AMSTERDAM, Netherlands, 1091 AC | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Holstebro Hospital, Endocrinology dept. Holstebro, Denmark, DK-7500 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Steno Diabetes Center Copenhagen Herlev, Denmark, 2730 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Bispebjerg Hospital København NV, Denmark, 2400 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sydvestjysk Sygehus Esbjerg Esbjerg, Denmark, 6700 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Health Corporation of the Ziv Medical Center (R.A.) Zefat, Israel, 1311001 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Barzilai Medical Center Ashkelon, Israel, 7830604 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Health Corporation of Galilee Medical Center Nahariya, Israel, 2210001 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clalit Health Services through HaEmek Medical Center Afula, Israel, 1834111 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clalit Health Services Rabin Medical Center-Beilinson Campus Petach Tikva, Israel, 4941492 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Edith Wolfson Medical Center Holon, Israel, 5822012 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Far Eastern Memorial Hospital New Taipei City, Taiwan, China, 220 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Changhua Christian Hospital Changhua, Taiwan, China, 50006 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Chang Gung Memorial Hospital Kaohsiung Kaohsiung, Taiwan, China, 833 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Taipei Medical University - Shuang Ho Hospital New Taipei City, Taiwan, China, 23561 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Taipei Veterans General Hospital Taipei, Taiwan, China, 11217 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Taichung Veterans General Hospital Taichung, Taiwan, China, 40705 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations China Medical University Hospital Taichung, Taiwan, China, 40447 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Friedrich-Schiller-Uni. Jena Jena, Germany, 07740 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinical Research Consultants Kansas City, United States, 64111 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Office of Osvaldo A. Brusco, MD Corpus Christi, United States, 78414-4173 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Academic Medical Research Institute Los Angeles, United States, 90022 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Cook County Health and Hospital System Chicago, United States, 60612 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kansas City VA Medical Center Kansas City, United States, 64128 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Meridian Clinical Research- Norfolk Norfolk, United States, 68701 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations DaVita Clinical Research - Texas El Paso, United States, 79935 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Circuit Clinical/Crystal Run Middletown, United States, 10941 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Salem VA Medical Center Salem, United States, 24153 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Tennessee Health Science Center Memphis, United States, 38163 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Randolph Medical Associates Asheboro, United States, 27203 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinical Advancement Center, PLLC San Antonio, United States, 78215 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Velocity Clinical Research, Cincinnati Cincinnati, United States, 45242 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations St. Louis Heart & Vascular, PC Saint Louis, United States, 63136 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Eastern Nephrology Associates / Greenville NC Greenville, United States, 27834 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Washington University School of Medicine St. Louis, United States, 63110 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Chase Medical Research, LLC Waterbury, United States, 06708 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Somnos Clinical Research Lincoln, United States, 68510 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Omega Clinical Research Center Metairie, United States, 70006 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Emory University School of Medicine Atlanta, United States, 30303 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Olympus Family Medicine Salt Lake City, United States, 84117 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Eastern Nephrology Associates - Kinston Kinston, United States, 28504 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Healor Primary Care / CCT Research Las Vegas, United States, 89102 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Versailles Family Medicine Versailles, United States, 40383 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of North Carolina Kidney Center Chapel Hill, United States, 27599-7155 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations IRCCS Casa Sollievo della Sofferenza Foggia, Italy, 71013 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. Pisana Pisa, Italy, 56124 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hamilton Medical Research Group Hamilton, Canada, L8M 1K7 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sameh Fikry Professional Corporation Waterloo, Canada, N2J 1C4 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centricity Research Mirabel Multispecialty Mirabel, Canada, J7J 2K8 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Recherche GCP Research Montreal, Canada, H1M 1B1 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations LMC Manna Research - Bayview Toronto, Canada, M4G 3E8 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations LMC Manna Research - Calgary Calgary, Canada, T2H 2G4 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Hospitalier de l’Université de Montréal (CHUM) Montréal, Canada, H2X 1P1 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Bluewater Clinical Research Group Sarnia, Canada, N7T 4X3 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations LMC Clinical Research Inc. Montreal Ville Saint-Laurent, Canada, H4T 1Z9 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations LMC Manna Research - Ottawa Nepean, Canada, K2J 0V2 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Severance Hospital, Yonsei University Health System Seoul, South Korea, 03722 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Asan Medical Center Seoul, South Korea, 05505 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Yonsei University Wonju Christian Hospital Wonju, South Korea, 26426 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hallym University Sacred Heart Hospital Anyang-si, South Korea, 14068 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Chung Nam National University Hospital Daejeon, South Korea, 35015 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Seoul National University Hospital Seoul, South Korea, 03080 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MultiCare Rockwood Clinic Diabetes & Endocrinology Center Spokane, United States, 99202 | Status Not yet recruiting | 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 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Biopharma Informatic, LLC McAllen, United States, 78503 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario Dr. Peset Valencia, Spain, 46017 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ciutat Sanitaria i Universitaria de la Vall d'Hebron Barcelona, Spain, 08023 | Status Not yet recruiting | 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 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
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
- Number 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
- Number 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
- Relative change from baseline in K+Timeframe: Up to 180 days
- Number 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
- Number of participants with symptomatic hypotension eventsTimeframe: Up to 180 days
- Total number of symptomatic hypotension eventsTimeframe: Up to 180 days
- Number of participants with genital mycotic eventsTimeframe: Up to 180 days
- Total number of genital mycotic eventsTimeframe: Up to 180 days
- Number of participants with ketoacidosis eventsTimeframe: Up to 180 days
- Total number of ketoacidosis eventsTimeframe: Up to 180 days
- Number 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
- Number of participants with urosepsis and pyelonephritis eventsTimeframe: Up to 180 days
- Total number of urosepsis and pyelonephritis eventsTimeframe: Up to 180 days
Additional Information
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