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Could two kidney drugs together be better than one?

NCT ID NCT05254002

Disease control Sponsor: Bayer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time

Summary

This study investigates whether taking two medications—finerenone and empagliflozin—together can better slow kidney function decline in people with chronic kidney disease and type 2 diabetes compared to taking either drug alone. Participants are randomly assigned to receive the combination, finerenone plus a placebo, or empagliflozin plus a placebo for six months. The main goal is to measure changes in urine protein levels, a key marker of kidney health.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
finerenone and empagliflozin
What this could lead to
If successful, this combination could offer a more effective way to slow kidney disease progression in people with type 2 diabetes, potentially reducing the need for dialysis or transplant.
What could go wrong
This is a phase 2 trial, so results are preliminary. The combination may not prove significantly better than each drug alone, and side effects from taking two medications together are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

1,664 people

The number who actually took part.

Started

Jun 2022

Finished

Mar 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic kidney disease Type 2 diabetes mellitus

Contacts and locations

Locations

  • ASL N 4 SSR Liguria_Ospedale di Chiavari - Diabetologia e Malattie Metaboliche

    Chiavari, Liguria, 16043, Italy

  • AZ Delta

    Roeselare, 8800, Belgium

  • AZ Groeninge Campus Kennedylaan

    Kortrijk, 8500, Belgium

  • Academic Medical Research Institute

    Los Angeles, California, 90022, United States

  • Albert Schweitzer Ziekenhuis | Dordwijk - Cardiology Department

    Dordrecht, South Holland, 3318 AT, Netherlands

  • All India Institute of Medical Sciences

    Bhubaneswar, National Capital Territory of Delhi, 751019, India

  • Ansan Hospital | Nephrology

    Gyeonggi-do, 425-707, South Korea

  • Area Sanitaria De Ferrol | Medicina Interna

    Ferrol, A Coruña, 15405, Spain

  • Asan Medical Center | Ophthalmology

    Seoul, Seoul Teugbyeolsi, 05505, South Korea

  • Asian Kidney Hospital and Medical Centre

    Nagpur, Maharashtra, 440010, India

  • Azienda Ospedaliero Universitaria Parma - SC Nefrologia

    Parma, Emilia-Romagna, 43126, Italy

  • Azienda Ospedaliero Universitaria Pisana_Cisanello - Malattie Metaboliche e Diabetologia

    Pisa, Tuscany, 56124, Italy

  • Azienda Ospedaliero-Universitaria San Luigi Gonzaga - Malattie Metaboliche Diabetologia

    Orbassano, Piedmont, 10043, Italy

  • Azienda Socio Sanitaria Locale N 2 Della Gallura - Diabetologia

    Olbia, Sardinia, 07026, Italy

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - Malattie Endocrine e Diabetologia

    Bergamo, Lombardy, 24127, Italy

  • Azienda Socio Sanitaria Territoriale Rhodense

    Rho, Lombardy, 20017, Italy

  • Azienda Socio Sanitaria Territoriale Santi Paolo e Carlo_Ospedale S. Paolo - Gestione integrata della malattia Diabetica

    Milan, Lombardy, 20142, Italy

  • Bangalore Medical College & Research Institute

    Bengaluru, India

  • Barzilai Medical Center | Department of Nephrology and Hypertension

    Ashkelon, 7830604, Israel

  • Biopharma Informatic - McAllen, TX

    McAllen, Texas, 78503, United States

  • Bispebjerg Hospital - Hjerteafdeling

    Copenhagen, Capital Region, 2400, Denmark

  • Blue Sky, MD/ Lamond Family Medicine

    Hendersonville, North Carolina, 28792, United States

  • Bluewater Clinical Research Group

    Sarnia, Ontario, N7T 4X3, Canada

  • CCT Research - Santa Rosa Medical Centers of Nevada

    Las Vegas, Nevada, 89119, United States

  • CHU Dijon - Hopital Francois Miterrand

    Dijon, Bourgogne-Franche-Comté, 21000, France

  • CHU de Charleroi Hôpital civil

    Lodelinsart, Hainaut, 6042, Belgium

  • Cardiologicum Pirna / Dresden-Seidnitz

    Pirna, Saxony, 1796, Germany

  • Casa Sollievo della Sofferenza - Endocrinologia

    San Giovanni Rotondo, Apulia, 71013, Italy

  • Center Hospitalier Michallon - Grenoble

    La Tronche (Grenoble Area), Auvergne-Rhône-Alpes, 38043, France

  • Center for Advanced Medicine - Diabetes Center

    St Louis, Missouri, 63110, United States

  • Centre Hospitalier de l'Universite de Montreal (CHUM) | Cardiology

    Montreal, Quebec, H2X 0A9, Canada

  • Chang Gung Memorial Hospital Kaohsiung

    Kaohsiung City, Kaohsiung, 833, Taiwan

  • Changhua Christian Hospital

    Changhua, Changhua, 50006, Taiwan

  • Charité Campus Benjamin Franklin (CBF)

    Berlin, State of Berlin, 12203, Germany

  • China Medical University Hospital

    Taichung, 404327, Taiwan

  • Circuit Clinical/Crystal Run

    Middletown, New York, 10941, United States

  • Clalit Health | Soroka Medical Center - Internal Medicine Department

    Beersheba, 8410101, Israel

  • ClinPhenomics GmbH&Co. KG

    Frankfurt am Main, Hesse, 60596, Germany

  • Clinical Advancement Center, PLLC

    San Antonio, Texas, 78212, United States

  • Clinical Research Consultants, a JCCT Company

    Kansas City, Missouri, 64111, United States

  • Clinical Research Solutions, Inc.

    Waterloo, Ontario, N2T 0C1, Canada

  • Complexo Hospitalario Universitario A Coruna | Endocrinologia y Nutricion

    A Coruña, A Coruña, 15006, Spain

  • DaVita Clinical Research- El Paso

    El Paso, Texas, 79925, United States

  • DarSalud Care / LifeDOC Research

    Memphis, Tennessee, 38119, United States

  • Diabetes Zentrum Wandsbek

    Hamburg, Free and Hanseatic City of Hamburg, 22041, Germany

  • Diabetologische Schwerpunkt Praxis Dortmund

    Dortmund, North Rhine-Westphalia, 44137, Germany

  • Dignity Health Northridge Hospital Medical Center - Nephrology

    Northridge, California, 91325, United States

  • Dr. Bantwal's Clinic

    Bengaluru, 560076, India

  • Dunes Clinical Research LLC

    Dakota Dunes, South Dakota, 57049, United States

  • Eastern Nephrology Associates - Greenville West

    Greenville, North Carolina, 27834, United States

  • Eastern Nephrology Associates - Kinston

    Kinston, North Carolina, 28504, United States

  • Edith Wolfson Medical Center | Internal Medicine Department

    Holon, 5822012, Israel

  • Eternal Heart Care Centre (EHCC) and Research Institute

    Jaipur, Rajasthan, 302020, India

  • Far Eastern Memorial Hospital | Nephrology Department

    New Taipei City, New Taipei, 220, Taiwan

  • Florida Kidney Physicians - Delray Beach Nephrology

    Delray Beach, Florida, 33445, United States

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Endocrinologia

    Milan, Lombardy, 20122, Italy

  • Friedrich-Schiller-Uni. Jena

    Jena, Thuringia, 7747, Germany

  • Fukui-ken Saiseikai Hospital

    Fukui-shi, Fukui, 918-8503, Japan

  • Fukuoka University Chikushi Hospital

    Chikushino-shi, Fukuoka, 818-8502, Japan

  • G.S.V.M. Medical College

    Kanpur, Uttar Pradesh, 208002, India

  • GCP Research | Montreal

    Montreal, Quebec, H1M 1B1, Canada

  • Gelre Ziekenhuizen

    Apeldoorn, Gelderland, 7334 DZ, Netherlands

  • Global Kidney Center

    Houston, Texas, 77008, United States

  • Government Kilpauk Medical College Hospital

    Chennai, Tamil Nadu, 600010, India

  • Government Medical College

    Kozhikode, Kerala, 673008, India

  • Government Medical College and Hospital (GMCH) Nagpur

    Nagpur, 440009, India

  • Grady Memorial Hospital - Endocrinology

    Atlanta, Georgia, 30303, United States

  • Grant Medical Foundation - Ruby Hall Clinic (RHC)

    Pune, Maharashtra, 411001, India

  • HaEmek Medical Center | Internal Medicine C Department - Research Unit

    Afula, 1834111, Israel

  • Hadassah University Medical Center (HUMC)

    Jerusalem, 911200, Israel

  • Hallym University Kangnam Sacred Heart Hospital

    Seoul, 7442, South Korea

  • Hallym University Sacred Heart Hospital

    Anyang-si, Gyeonggido, 14068, South Korea

  • Hamilton Medical Research Group

    Hamilton, Ontario, L8M 1K7, Canada

  • Hanyang University Guri Hospital

    Guri-si, Gyeonggi-do, 471-701, South Korea

  • Healor Primary Care / CCT Research

    Las Vegas, Nevada, 89102, United States

  • Health Corporation of Galilee Medical Center

    Nahariya, 2210001, Israel

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

    Safed, 1311001, Israel

  • Hirohata Naika Clinic

    Kitakyushu, Fukuoka, 807-0857, Japan

  • Hopital Carémeau - Nîmes

    Nîmes, Occitanie, 30029, France

  • Hospital Clinico Universitario De Valencia | Cardiologia

    Valencia, Valencia, 46010, Spain

  • Hospital Nisa Sevilla Aljarafe | Endocrinologia y Nutricion

    Castilleja de la Cuesta, Sevilla, 41950, Spain

  • Hospital Quironsalud Barcelona | Internal Medicine Department

    Barcelona, Barcelona, 8023, Spain

  • Hospital Universitari Vall D Hebron | Nefrologia

    Barcelona, Barcelona, 08035, Spain

  • Hospital Universitario Dr Peset Aleixandre | Nefrologia

    Valencia, Valencia, 46017, Spain

  • Hospital Universitario Fundacion Jimenez Diaz | Nephrology and Hypertension Department

    Madrid, Madrid, 28040, Spain

  • Hospital Universitario Principe De Asturias | Nefrologia

    Alcalá de Henares, Madrid, 28805, Spain

  • Hospital Universitario Puerta De Hierro De Majadahonda | Nefrologia

    Majadahonda, Madrid, 28222, Spain

  • Hospital Universitario Virgen De La Victoria | Endocrinologia y Nutricion

    Málaga, Málaga, 20910, Spain

  • Hospital Universitario Virgen De Las Nieves | Medicina Interna

    Granada, Granada, 18014, Spain

  • Hospital of South West Jutland | Department of Endocrinology Research

    Esbjerg, Region Syddanmark, 6700, Denmark

  • Hôpital Edouard Herriot - Lyon Cedex

    Lyon, Auvergne-Rhône-Alpes, 69003, France

  • Hôpital Saint Joseph

    Paris, Île-de-France Region, 75014, France

  • Indraprastha Apollo Hospital

    New Delhi, National Capital Territory of Delhi, 110076, India

  • Innovative Research Institute

    Port Charlotte, Florida, 33952, United States

  • Institute of Post-Graduate Medical Education and Research

    Kolkata, West Bengal, 700020, India

  • Jan Yperman Ziekenhuis

    Ieper, 8900, Belgium

  • Jiyugaoka Yamada Internal Medicine Clinic

    Obihiro, Hokkaido, 080-0848, Japan

  • K.L.E.S. Dr. Prabhakar Kore Hospital & Medical Research Centre

    Belagavi, Karnataka, 590010, India

  • Kansas City VA Medical Center - Endocrinology

    Kansas City, Missouri, 64128, United States

  • King George Hospital

    Visakhapatnam, Andhra Pradesh, 530002, India

  • Kokura Memorial Hospital

    Kitakyushu, Fukuoka, 802-8555, Japan

  • Krishna Institute Of Medical Science

    Secunderabad, Telangana, 500003, India

  • Kyung Hee University Hospital at Gangdong

    Seoul, 5278, South Korea

  • LMC Clinical Research Inc. Montreal

    Saint-Laurent, Quebec, H4T 1Z9, Canada

  • Lake Michigan Nephrology

    Saint Joseph, Michigan, 49085, United States

  • Lifepoint Multispecialty Hospital

    Pune, 411057, India

  • Manipal Hospital

    Mysore, Karnataka, 570015, India

  • Many Locations

    Many Locations, France

  • Many Locations

    Many Locations, Italy

  • Many Locations

    Many Locations, Japan

  • Many Locations

    Many Locations, Spain

  • Many Locations

    Many Locations, Taiwan

  • Mavani Dialysis & Kidney Center

    Ahmedabad, Gujarat, 380052, India

  • Max Super Speciality Hospital (MSSH) - Saket

    New Delhi, 110017, India

  • Meander Medisch Centrum

    Amersfoort, Utrecht, 3818 TZ, Netherlands

  • Medical Corporation Taifukukai, Osaka Nishiumeda Clinic

    Osaka, Osaka, 530-0001, Japan

  • Metabolic Research Institute, Inc.

    West Palm Beach, Florida, 33401, United States

  • MultiCare Rockwood Clinic Diabetes & Endocrinology Center

    Spokane, Washington, 99202, United States

  • Naka Kinen Clinic

    Naka, Ibaraki, 311-0113, Japan

  • Nizam's Institute of Medical Sciences (NIMS)

    Hyderabad, Telangana, 500082, India

  • Nola Care Clinical Research

    Metairie, Louisiana, 70006, United States

  • North Texas Kidney Disease Associates Lewisville

    Lewisville, Texas, 75057, United States

  • Oakland Medical Research

    Troy, Michigan, 48085, United States

  • Office of Osvaldo A. Brusco, MD

    Corpus Christi, Texas, 78414, United States

  • Olive View - UCLA Medical Center

    Sylmar, California, 91342-1437, United States

  • Olympus Family Medicine

    Salt Lake City, Utah, 84117, United States

  • Omega Clinical Research - Metairie

    Metairie, Louisiana, 70006, United States

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, North Holland, 1091 AC, Netherlands

  • Onze-Lieve-Vrouwziekenhuis (OLVZ) - Campus Aalst

    Aalst, Oost-vlaanderen, 9300, Belgium

  • Osaka General Medical Center

    Osaka, Osaka, 558-8558, Japan

  • Osmania General Hospital

    Telangana, Telangana, 500012, India

  • Ospedale San Raffaele s.r.l. - Medicina Generale Indirizzo Diabetologico ed Endocrino-Metabolico

    Milan, Lombardy, 20132, Italy

  • Public Central Hospital of Matto Ishikawa | Clinical Trial Management Office

    Hakusan, Ishikawa-ken, 924-8588, Japan

  • Randolph Health Internal Medicine in Asheboro

    Asheboro, North Carolina, 27203, United States

  • Region Midtjylland | Regionshospitalet Godstrup - Nephrology Department

    Herning, Central Jutland, 7400, Denmark

  • Saiseikai Matsuyama Hospital

    Matsuyama, Ehime, 791-8026, Japan

  • Salem VA Medical Center - Endocrinology

    Salem, Virginia, 24153, United States

  • Sameh Fikry Professional Corporation

    Waterloo, Ontario, N2J 1C4, Canada

  • Sawami Man Singh (SMS) Medical College & Attached Hospitals

    Jaipur, Rajasthan, 302017, India

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggido, 13620, South Korea

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi, 3080, South Korea

  • Seth Gordhandas Sunderdas Medical College (GSMC) - King Edward Memorial (KEM) Hospital

    Mumbai, Maharashtra, 400012, India

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul Teugbyeolsi, 03722, South Korea

  • Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital

    Fukuoka, Fukuoka, 811-0213, Japan

  • Somnos Clinical Research

    Lincoln, Nebraska, 68510, United States

  • Soon Chun Hyang University Cheonan Hospital

    Cheonan, Chungcheongnam-do, 31151, South Korea

  • South Shore Nephrology

    Plymouth, Massachusetts, 02360, United States

  • Southeast Kidney Associates - East Point

    East Point, Georgia, 30344, United States

  • Southwest Kidney Institute, PLC - Suprise

    Surprise, Arizona, 85374, United States

  • Sriram Chandra Bhanj Medical College & Hospital

    Cuttack, India

  • St. Louis Heart and Vascular, PC - Christian Hospital Office

    St Louis, Missouri, 63136, United States

  • Steno Diabetes Center Copenhagen | Herlev - Clinical and Translational Research Department

    Herlev, Capital Region, 2730, Denmark

  • Taichung Veterans General Hospital

    Taichung, Taichung, 40705, Taiwan

  • Taipei Medical University - Shuang Ho Hospital

    New Taipei City, New Taipei, 23561, Taiwan

  • Taipei Veterans General Hospital

    Taipei, Taipei, 11217, Taiwan

  • The Catholic University of Korea, Incheon St.Mary's Hospital

    Incheon, Incheon Gwang''Yeogsi, 21431, South Korea

  • The University of Tennessee Health Science Center - Medical Center Clinic - Nephrology

    Memphis, Tennessee, 38163, United States

  • Thyroid, Endocrinology, and Diabetes - Dallas

    Dallas, Texas, 75208, United States

  • Touro University California - Metabolic Research Center

    Vallejo, California, 94592, United States

  • UNC Hospitals Outpatient Center at Eastowne - Nephrology

    Chapel Hill, North Carolina, 27514, United States

  • UT Health San Antonio - Medical Arts & Research Center - Endocrinology

    San Antonio, Texas, 78229, United States

  • UZ Gent

    Ghent, 9000, Belgium

  • UZ Leuven Gasthuisberg

    Leuven, 3000, Belgium

  • Università degli Studi "G. D'Annunzio" di Chieti - Endocrinologia

    Chieti, 66100, Italy

  • Vedanta Kidney Care

    Vadodara, Gujarat, 390007, India

  • Velocity Clinical Research - Blue Ash

    Cincinnati, Ohio, 45242, United States

  • Velocity Clinical Research - Savannah

    Savannah, Georgia, 31406, United States

  • Victorium Clinical Research

    Houston, Texas, 77024-2593, United States

  • Vinaya Hospital and Research Centre (A Unit of KIMS)

    Mangalore, Karnataka, 575003, India

  • West Orange Endocrinology & Clinical Research

    Ocoee, Florida, 34761, United States

  • William Osler Health centre, Sakuara Medical

    Mississauga, Ontario, L5H4K9, Canada

  • Yonsei University Wonju Christian Hospital

    Wŏnju, Gang''Weondo, 26426, South Korea

  • Zentrum für Diabetologie und Ernährungsmedizin

    Ludwigshafen am Rhein, Rhineland-Palatinate, 67059, Germany

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