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:

NCT05254002

EudraCT Number:

2021-003037-11

Recruiting

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
807
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
Kerendia (Finerenone, BAY94-8862)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Many Locations

Many Locations, Italy

Status
Not yet recruiting
 
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Many Locations

Many Locations, Taiwan, China

Status
Not yet recruiting
 
Locations

Meridian Clinical Research- Savannah

Savannah, United States, 31406

Status
Not yet recruiting
 
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Many Locations

Many Locations, Japan

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Not yet recruiting
 
Locations

Many Locations

Many Locations, France

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Not yet recruiting
 
Locations

Many Locations

Many Locations, Spain

Status
Not yet recruiting
 
Locations

Diabetologische Schwerpunkt Praxis Dortmund

Dortmund, Germany, 44137

Status
Not yet recruiting
 
Locations

Zentrum für Diabetologie und Ernährungsmedizin

Ludwigshafen, Germany, 67059

Status
Recruiting
 
Locations

St. Josefskrankenhaus

Heidelberg, Germany, 69115

Status
Not yet recruiting
 
Locations

Diabetes Zentrum Wandsbek

Hamburg, Germany, 22041

Status
Not yet recruiting
 
Locations

Cardiologicum Pirna / Dresden-Seidnitz

Pirna, Germany, 01796

Status
Not yet recruiting
 
Locations

Charité Campus Benjamin Franklin (CBF)

Berlin, Germany, 12203

Status
Not yet recruiting
 
Locations

ClinPhenomics GmbH&Co. KG

Frankfurt, Germany, 60596

Status
Recruiting
 
Locations

Hopital Carémeau - Nîmes

NIMES cedex 9, France, 30029

Status
Recruiting
 
Locations

Center Hospitalier Michallon - Grenoble

LA TRONCHE, France, 38700

Status
Recruiting
 
Locations

Hôpital François Mitterrand - Dijon

DIJON, France, 21000

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Not yet recruiting
 
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Hopital Carémeau - Nîmes

NIMES cedex 9, France, 30029

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Not yet recruiting
 
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Hôpital Edouard Herriot - Lyon Cedex

LYON CEDEX, France, 69437

Status
Not yet recruiting
 
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Hôpital Saint Joseph

PARIS, France, 75014

Status
Recruiting
 
Locations

Saiseikai Matsuyama Hospital

Matsuyama, Japan, 791-8026

Status
Not yet recruiting
 
Locations

Osaka General Medical Center

Osaka, Japan, 558-8558

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Not yet recruiting
 
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Kyosokai AMC NISHI-UMEDA Clinic

Osaka, Japan, 530-0001

Status
Recruiting
 
Locations

Fukuoka University Chikushi Hospital

Chikushino, Japan, 818-8502

Status
Not yet recruiting
 
Locations

Japanese Red Cross Kumamoto Hospital

Kumamoto, Japan, 861-8520

Status
Not yet recruiting
 
Locations

Nakakinen Clinic

Naka, Japan, 311-0113

Status
Recruiting
 
Locations

Kokura Memorial Hospital

Kitakyushu, Japan, 802-8555

Status
Not yet recruiting
 
Locations

Hirohata Naika Clinic

Kitakyushu, Japan, 807-0857

Status
Recruiting
 
Locations

Fukui-ken Saiseikai Hospital

Fukui, Japan, 918-8503

Status
Not yet recruiting
 
Locations

Fukuoka Wajiro Hospital

Fukuoka, Japan, 811-0213

Status
Recruiting
 
Locations

Ospedale San Raffaele s.r.l.

Milano, Italy, 20132

Status
Not yet recruiting
 
Locations

ATS Sardegna - ASSL Olbia

Sassari, Italy, 07026

Status
Not yet recruiting
 
Locations

ASST Papa Giovanni XXIII

Bergamo, Italy, 24127

Status
Not yet recruiting
 
Locations

ASST Santi Paolo e Carlo

Milano, Italy, 20142

Status
Not yet recruiting
 
Locations

A.O.U.I. Verona

Verona, Italy, 37126

Status
Not yet recruiting
 
Locations

ASL 4 Chiavarese

Genova, Italy, 16043

Status
Not yet recruiting
 
Locations

A.O.U. San Luigi Gonzaga

Torino, Italy, 10043

Status
Not yet recruiting
 
Locations

ASST Rhodense

Milano, Italy, 20024

Status
Not yet recruiting
 
Locations

A.O.U. di Parma

Parma, Italy, 43126

Status
Not yet recruiting
 
Locations

Hospital Quirón

Barcelona, Spain, 08023

Status
Recruiting
 
Locations

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Status
Not yet recruiting
 
Locations

Complejo Hospitalario Universitario A Coruña

A Coruña, Spain, 15006

Status
Recruiting
 
Locations

Hospital Universitario Virgen de las Nieves

Granada, Spain, 18012

Status
Not yet recruiting
 
Locations

Hospital Principe de Asturias

Alcalá de Henares, Spain, 28805

Status
Recruiting
 
Locations

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, Spain, 15706

Status
Not yet recruiting
 
Locations

Hospital Clínico Universitario de Valencia

Valencia, Spain, 46010

Status
Recruiting
 
Locations

Complexo Hospitalario Universitario de Ferrol

Ferrol, Spain, 15405

Status
Recruiting
 
Locations

UZ Gent

GENT, Belgium, 9000

Status
Recruiting
 
Locations

UZ Leuven Gasthuisberg

LEUVEN, Belgium, 3000

Status
Not yet recruiting
 
Locations

Regionaal ZH Jan Yperman Campus Mariaziekenhuis

IEPER, Belgium, 8900

Status
Not yet recruiting
 
Locations

AZ Groeninge Campus Kennedylaan

KORTRIJK, Belgium, 8500

Status
Not yet recruiting
 
Locations

AZ Delta

ROESELARE, Belgium, 8800

Status
Recruiting
 
Locations

CHU de Charleroi Hôpital civil

Lodelinsart, Belgium, 6042

Status
Not yet recruiting
 
Locations

AZ St-Lucas Campus St-Lucas

GENT, Belgium, 9000

Status
Not yet recruiting
 
Locations

Albert Schweitzer Ziekenhuis, Dordwijk

DORDRECHT, Netherlands, 3318 AT

Status
Not yet recruiting
 
Locations

Academisch Medisch Centrum (AMC)

AMSTERDAM, Netherlands, 1105 AZ

Status
Not yet recruiting
 
Locations

Gelre Ziekenhuizen

APELDOORN, Netherlands, 7334 DZ

Status
Not yet recruiting
 
Locations

Meander Medisch Centrum

AMERSFOORT, Netherlands, 3818 TZ

Status
Not yet recruiting
 
Locations

OLVG - locatie Oost

AMSTERDAM, Netherlands, 1091 AC

Status
Recruiting
 
Locations

Holstebro Hospital, Endocrinology dept.

Holstebro, Denmark, DK-7500

Status
Not yet recruiting
 
Locations

Steno Diabetes Center Copenhagen

Herlev, Denmark, 2730

Status
Not yet recruiting
 
Locations

Bispebjerg Hospital

København NV, Denmark, 2400

Status
Not yet recruiting
 
Locations

Sydvestjysk Sygehus Esbjerg

Esbjerg, Denmark, 6700

Status
Not yet recruiting
 
Locations

Health Corporation of the Ziv Medical Center (R.A.)

Zefat, Israel, 1311001

Status
Not yet recruiting
 
Locations

Barzilai Medical Center

Ashkelon, Israel, 7830604

Status
Not yet recruiting
 
Locations

Health Corporation of Galilee Medical Center

Nahariya, Israel, 2210001

Status
Not yet recruiting
 
Locations

Clalit Health Services through HaEmek Medical Center

Afula, Israel, 1834111

Status
Recruiting
 
Locations

Clalit Health Services Rabin Medical Center-Beilinson Campus

Petach Tikva, Israel, 4941492

Status
Not yet recruiting
 
Locations

Edith Wolfson Medical Center

Holon, Israel, 5822012

Status
Not yet recruiting
 
Locations

Far Eastern Memorial Hospital

New Taipei City, Taiwan, China, 220

Status
Not yet recruiting
 
Locations

Changhua Christian Hospital

Changhua, Taiwan, China, 50006

Status
Not yet recruiting
 
Locations

Chang Gung Memorial Hospital Kaohsiung

Kaohsiung, Taiwan, China, 833

Status
Not yet recruiting
 
Locations

Taipei Medical University - Shuang Ho Hospital

New Taipei City,, Taiwan, China, 23561

Status
Not yet recruiting
 
Locations

Taipei Veterans General Hospital

Taipei, Taiwan, China, 11217

Status
Not yet recruiting
 
Locations

Taichung Veterans General Hospital

Taichung, Taiwan, China, 40705

Status
Not yet recruiting
 
Locations

China Medical University Hospital

Taichung, Taiwan, China, 40447

Status
Not yet recruiting
 
Locations

Friedrich-Schiller-Uni. Jena

Jena, Germany, 07740

Status
Not yet recruiting
 
Locations

Clinical Research Consultants

Kansas City, United States, 64111

Status
Not yet recruiting
 
Locations

Office of Osvaldo A. Brusco, MD

Corpus Christi, United States, 78414

Status
Not yet recruiting
 
Locations

Academic Medical Research Institute

Los Angeles, United States, 90022

Status
Not yet recruiting
 
Locations

Cook County Health and Hospital System

Chicago, United States, 60612

Status
Not yet recruiting
 
Locations

Kansas City VA Medical Center

Kansas City, United States, 64128

Status
Recruiting
 
Locations

Meridian Clinical Research- Norfolk

Norfolk, United States, 68701

Status
Not yet recruiting
 
Locations

DaVita Clinical Research - Texas

El Paso, United States, 79935

Status
Not yet recruiting
 
Locations

Circuit Clinical/Crystal Run

Middletown, United States, 10941

Status
Not yet recruiting
 
Locations

Salem VA Medical Center

Salem, United States, 24153

Status
Recruiting
 
Locations

University of Tennessee Health Science Center

Memphis, United States, 38163

Status
Not yet recruiting
 
Locations

Randolph Medical Associates

Asheboro, United States, 27203

Status
Not yet recruiting
 
Locations

Clinical Advancement Center, PLLC

San Antonio, United States, 78215

Status
Not yet recruiting
 
Locations

Velocity Clinical Research, Cincinnati

Cincinnati, United States, 45242

Status
Not yet recruiting
 
Locations

St. Louis Heart & Vascular, PC

St. Louis, United States, 63136

Status
Not yet recruiting
 
Locations

Eastern Nephrology Associates / Greenville NC

Greenville, United States, 27834

Status
Not yet recruiting
 
Locations

Washington University School of Medicine

St. Louis, United States, 63110

Status
Not yet recruiting
 
Locations

Chase Medical Research, LLC

Waterbury, United States, 06708

Status
Not yet recruiting
 
Locations

Somnos Clinical Research

Lincoln, United States, 68510

Status
Not yet recruiting
 
Locations

Omega Clinical Research Center

Metairie, United States, 70006

Status
Not yet recruiting
 
Locations

Emory University School of Medicine

Atlanta, United States, 30303

Status
Not yet recruiting
 
Locations

Olympus Family Medicine

Salt Lake City, United States, 84117

Status
Not yet recruiting
 
Locations

Eastern Nephrology Associates - Kinston

Kinston, United States, 28504

Status
Not yet recruiting
 
Locations

Desert Clinical Research - CCT Research

Mesa, United States, 85213

Status
Not yet recruiting
 
Locations

Healor Primary Care / CCT Research

Las Vegas, United States, 89102

Status
Not yet recruiting
 
Locations

Versailles Family Medicine

Versailles, United States, 40383

Status
Not yet recruiting
 
Locations

University of North Carolina Kidney Center

Chapel Hill, United States, 27599-7155

Status
Not yet recruiting
 
Locations

IRCCS Casa Sollievo della Sofferenza

Foggia, Italy, 71013

Status
Not yet recruiting
 
Locations

A.O.U. Pisana

Pisa, Italy, 56124

Status
Not yet recruiting
 
Locations

Hamilton Medical Research Group

Hamilton, Canada, L8M 1K7

Status
Not yet recruiting
 
Locations

Sameh Fikry Professional Corporation

Waterloo, Canada, N2J 1C4

Status
Recruiting
 
Locations

Centricity Research Mirabel Multispecialty

Mirabel, Canada, J7J 2K8

Status
Not yet recruiting
 
Locations

Recherche GCP Research

Montreal, Canada, H1M 1B1

Status
Recruiting
 
Locations

LMC Manna Research - Bayview

Toronto, Canada, M4G 3E8

Status
Not yet recruiting
 
Locations

LMC Manna Research - Calgary

Calgary, Canada, T2H 2G4

Status
Not yet recruiting
 
Locations

Centre Hospitalier de l’Université de Montréal (CHUM)

Montréal, Canada, H2X 1P1

Status
Not yet recruiting
 
Locations

Bluewater Clinical Research Group

Sarnia, Canada, N7T 4X3

Status
Not yet recruiting
 
Locations

LMC Clinical Research Inc. Montreal

Ville Saint-Laurent, Canada, H4T 1Z9

Status
Not yet recruiting
 
Locations

LMC Manna Research - Ottawa

Nepean, Canada, K2J 0V2

Status
Not yet recruiting
 
Locations

Severance Hospital, Yonsei University Health System

Seoul, South Korea, 03722

Status
Not yet recruiting
 
Locations

Asan Medical Center

Seoul, South Korea, 05505

Status
Not yet recruiting
 
Locations

Yonsei University Wonju Christian Hospital

Wonju, South Korea, 26426

Status
Not yet recruiting
 
Locations

Hallym University Sacred Heart Hospital

Anyang-si, South Korea, 14068

Status
Not yet recruiting
 
Locations

Chung Nam National University Hospital

Daejeon, South Korea, 35015

Status
Not yet recruiting
 
Locations

Seoul National University Hospital

Seoul, South Korea, 03080

Status
Not yet recruiting
 
Locations

MultiCare Rockwood Clinic Diabetes & Endocrinology Center

Spokane, United States, 99202

Status
Not yet recruiting
 
Locations

Santa Rosa Medical Centers of Nevada / CCT Research

Las Vegas, United States, 89119

Status
Not yet recruiting
 

Trial Design