Trial Condition(s):
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)
21839
2023-506981-30-00
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.
- 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.
- 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).
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Locations Mavani Dialysis & Kidney Center Ahmedabad, India, NA | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sriram Chandra Bhanj Medical College & Hospital Cuttack, India, NA | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vedanta Kidney Care Vadodara, India, NA | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Government Kilpauk Medical College Hospital Chennai, India, NA | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Indraprastha Apollo Hospital New Delhi, India, 110076 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Osmania General Hospital Telangana, India, 500012 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Government Medical College and Hospital (GMCH) Nagpur Nagpur, India, 440009 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Grant Medical Foundation - Ruby Hall Clinic (RHC) Pune, India, 411001 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations King George Hospital Visakhapatnam, India, NA | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Asian Kidney Hospital and Medical Centre Nagapur, India, 440010 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nizam's Institute of Medical Sciences (NIMS) Hyderabad, India, 500082 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Dunes Clinical Research LLC Dakota Dunes, United States, 57049 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations DarSalud Care / LifeDOC Research Memphis, United States, 38119 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Dr Nowreen Haq Endocrinology Clinic Annapolis, United States, 21401 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations West Orange Endocrinology & Clinical Research Ocoee, United States, 34761-4547 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Innovative Research Institute Port Charlotte , United States, 33952 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Victorium Clinical Research Houston, United States, 77024-2593 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations South Shore Nephrology Plymouth, United States, 02360 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Global Kidney Center Houston, United States, 77008 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Oakland Medical Center Troy, United States, 48085 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nola Care Clinical Research Metairie, United States, 70006 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Thyroid, Endocrinology, and Diabetes (TED) PA Dallas, United States, 75208-2362 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Lake Michigan Nephrology Saint Joseph, United States, 49085 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations North Texas Kidney Disease Associates, PLLC Lewisville, United States, 75057 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Florida Kidney Physicians Delray Beach, United States, 33445 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Southeast Kidney Associates East Point, United States, 30344 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Touro University California Vallejo, United States, 94592 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Northridge Hospital Northridge, United States, 91325 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Olive View - UCLA Medical Center Sylmar, United States, 91342-1437 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Baliga Family Practice Columbus, United States, 31904 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Southwest Kidney Institute, PLC Surprise, United States, 85374 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Advent Health Orlando, United States, 32804 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Metabolic Research Institute, Inc. West Palm Beach, United States, 33401-3430 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Texas Health Science Center San Antonio, United States, 78249 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Jiyugaoka Yamada Internal Medicine Clinic Obihiro, Japan, 080-0848 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano, Italy, 20122 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universita Degli Studi "Gabriele d'Annunzio" - Chieti - Centro Scienze dell'Invecchiamento (Centro Studi Sull'Invecchiamento Chieti, Italy, 66100 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations William Osler Health centre, Sakuara Medical Mississauga, Canada, L5H4K9 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Onze-Lieve-Vrouwziekenhuis (OLVZ) - Campus Aalst Aalst, Belgium, 9300 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Soroka University Medical Center Beer Sheva, Israel, 8410101 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kyung Hee University Hospital at Gangdong Seoul, South Korea, 05278 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Seoul National University Bundang Hospital Seongnam-si, South Korea, 13620 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hanyang University Guri Hospital Gyeonggi-do, South Korea, 11923 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hallym University Kangnam Sacred Heart Hospital Seoul, South Korea, 7442 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Korea University Ansan Hospital Ansan Si, Kyung ki Do, South Korea, 425-707 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The Catholic University of Korea, Incheon St.Mary's Hospital Incheon, South Korea, 21431 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Public Central Hospital of Matto Ishikawa Hakusan, Japan, 924-8588 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Soon Chun Hyang University Cheonan Hospital Cheonan, South Korea, 31151 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hadassah University Medical Center (HUMC) Jerusalem, Israel, 911200 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Max Super Speciality Hospital (MSSH) - Saket New Delhi, India, 110017 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations All India Institute of Medical Sciences Bhubaneswar, India, 751019 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nephrology Associates Of Northern Illinois And Ind - Fort Wayne Fort Wayne, United States, 46804 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nephrology Associates of Northern Illinois and Indiana (NANI) - Hinsdale Hinsdale, United States, 60521 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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