EMPA-KIDNEY (The Study of Heart and Kidney Protection With Empagliflozin)
NCT ID: NCT03594110
Last Updated: 2025-07-20
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
6609 participants
INTERVENTIONAL
2019-01-31
2024-07-02
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Empagliflozin in Patients With Autosomal Dominant Polycystic Kidney Disease (EMPA-PKD)
NCT06391450
Early Treatment With a Sodium-glucose Co-transporter 2 Inhibitor in High-risk Patients With Acute Heart Failure
NCT05392764
A Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease (EMPA-KIDNEY® Kids)
NCT07107945
A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease
NCT03036150
A Study to Investigate the Mechanistic Effects of Dapagliflozin Alone or in Combination With Balcinrenone, Compared to Balcinrenone and Placebo on Body Fluid and Electrolyte Handling and Energy Metabolism in Participants Over 50 Years of Age With Chronic Kidney Disease.
NCT05884866
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Empagliflozin 10 mg
Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily 10 milligram (mg) film-coated tablets of empagliflozin.
Empagliflozin
Taken daily with or without food
Placebo
Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily film-coated tablets of placebo to match empagliflozin.
Matching placebo
Taken daily with or without food
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Empagliflozin
Taken daily with or without food
Matching placebo
Taken daily with or without food
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Evidence of chronic kidney disease at risk of kidney disease progression defined by at least 3 months before and at the time of Screening Visit
* CKD-EPI eGFR ≥20 to \<45 mL/min/1.73m² or
* CKD-EPI eGFR ≥45 to \<90 mL/min/1.73m² with urinary albumin:creatinine ratio ≥200 mg/g (or protein:creatinine ratio ≥300 mg/g);
* Clinically appropriate doses of single agent RAS-inhibition with either ACEi or ARB unless such treatment is either not tolerated or not indicated
* A local Investigator judges that the participant neither requires empagliflozin (or any other SGLT-2 or SGLT-1/2 inhibitor), nor that such treatment is inappropriate;
Exclusion Criteria
* Diabetes mellitus type 2 and prior atherosclerotic cardiovascular disease with an eGFR \>60 mL/min/1.73m2 at Screening
* Receiving combined ACEi and ARB treatment
* Maintenance dialysis, functioning kidney transplant, or scheduled living donor transplant
* Polycystic kidney disease
* Previous or scheduled bariatric surgery
* Ketoacidosis in the past 5 years
* Symptomatic hypotension, or systolic blood pressure \<90 or \>180 mmHg at Screening
* ALT or AST \>3x ULN at Screening
* Hypersensitivity to empagliflozin or other SGLT-2 inhibitor
* Any intravenous immunosuppression therapy in last 3 months; or anyone currently on \>45 mg prednisolone (or equivalent)
* Use of an investigational medicinal product in the 30 days prior to Screening visit
* Known to be poorly compliant with clinic visits or prescribed medication
* Medical history that might limit the individual's ability to take trial treatments for the duration of the study (e.g. severe respiratory disease; history of cancer or evidence of spread within last 4 years, other than non-melanoma skin cancer; or recent history of alcohol or substance misuse)
* Current pregnancy, lactation or women of childbearing potential (WOCBP), unless using highly-effective contraception
* Type 1 diabetes mellitus
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Oxford
OTHER
Eli Lilly and Company
INDUSTRY
Boehringer Ingelheim
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Nephrology Consultants, LLC
Huntsville, Alabama, United States
Aventiv Research, Inc
Mesa, Arizona, United States
Southern California Permanente Medical Group
San Diego, California, United States
University of California Los Angeles
Sylmar, California, United States
University of California Los Angeles
Torrance, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Chase Medical Research, LLC
Thomaston, Connecticut, United States
Midland Florida Clinical Reearch Center, LLC
DeLand, Florida, United States
University of Florida
Gainesville, Florida, United States
East Coast Institute for Research, LLC
Jacksonville, Florida, United States
East Coast Clinical Research, Inc
Lake City, Florida, United States
Total Research Group, LLC
Miami, Florida, United States
Hanson Clinical Research Center, Inc.
Port Charlotte, Florida, United States
Emory University
Atlanta, Georgia, United States
The Jones Center for Diabetes and Endocrine Wellness
Macon, Georgia, United States
Cedar Crosse Research Center
Chicago, Illinois, United States
Northwestern University
Chicago, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Saint Elizabeth Healthcare
Covington, Kentucky, United States
Lexington VA Health Care System - Troy Bowling Campus
Lexington, Kentucky, United States
Medstar Health Research Institute
Baltimore, Maryland, United States
Kidney Care and Transplant Services of New England, PC
West Springfield, Massachusetts, United States
Saint Clair Specialty Physicians
Roseville, Michigan, United States
Clinical Research Consultants, LLC
Kansas City, Missouri, United States
VA Southern Nevada Healthcare System
North Las Vegas, Nevada, United States
Seacoast Kidney and Hypertension Specialists
Portsmouth, New Hampshire, United States
SUNY Downstate Medical Center
Brooklyn, New York, United States
Mountain Kidney and Hypertension Associates, PA
Asheville, North Carolina, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Brookview Hills Research Associates LLC
Winston-Salem, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Carolina Diabetes & Kidney Center
Sumter, South Carolina, United States
Regional Health Clinical Research
Rapid City, South Dakota, United States
Research Institute of Dallas
Dallas, Texas, United States
Renal Disease Research Institute
Dallas, Texas, United States
Academy Of Diabetes, Thyroid And Endocrine, PA
El Paso, Texas, United States
Pioneer Research Solutions, Inc.
Houston, Texas, United States
P&I Clinical Research, LLC
Lufkin, Texas, United States
Texas Institute for Kidney and Endocrine Disorders
Lufkin, Texas, United States
Clinical Advancement Center PLLC
San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, United States
Salem VA Medical Center
Salem, Virginia, United States
Providence Medical Research Center
Spokane, Washington, United States
Kelowna General Hospital
Kelowna, British Columbia, Canada
Kidney Care Centre - Surrey
Surrey, British Columbia, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
LMC Clinical Research Inc. (Brampton)
Brampton, Ontario, Canada
Cambridge Cardiac Care Centre
Cambridge, Ontario, Canada
LMC Clinical Research Inc. (Thornhill)
Concord, Ontario, Canada
LMC Endocrinology Centres (Etobicoke) Ltd.
Etobicoke, Ontario, Canada
London Health Science Centre, University Campus
London, Ontario, Canada
LMC Clinical Research Inc. (Ottawa)
Nepean, Ontario, Canada
Lakeridge Health Oshawa
Oshawa, Ontario, Canada
LMC Clinical Research Inc. (Bayview)
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Fadia El Boreky Medicine Professional
Waterloo, Ontario, Canada
Clinical Research Solutions Inc.
Waterloo, Ontario, Canada
Montreal Clinical Research Institute (IRCM)
Montreal, Quebec, Canada
Hôpital du Sacré-Coeur de Montréal
Montreal, Quebec, Canada
CHUS Hopital Fleurimont
Sherbrooke, Quebec, Canada
CHU de Quebec-Universite Laval Research Centre
Québec, , Canada
IUCPQ (Laval University)
Québec, , Canada
Beijing AnZhen Hospital
Beijing, , China
Cardiovascular Institute and Fu Wai Hospital
Beijing, , China
Xiangya Hospital, Central South University
Changsha, , China
Xinqiao Hospital
Chongqing, , China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, , China
Jinzhou Central Hospital
Jinzhou, , China
Jinling Hospital
Nanjing, , China
Shanghai Fifth People's Hospital affiliated to Fudan University
Shanghai, , China
Shenzhen People's Hospital
Shenzhen, , China
Huazhong University of Science and Technology Union Shenzhen Hospital
Shenzhen, , China
People's Hospital of Sichuan Province
Sichuan, , China
SuZhou Kowloon Hospital
Suzhou, , China
The Central Hospital of Wuhan
Wuhan, , China
Wuhan Fourth Hospital
Wuhan, , China
Henan Provincial People's Hospital
Zhengzhou, , China
Zhuzhou Central Hospital
Zhuzhou, , China
Zhuzhou Central Hospital
Zhuzhou, , China
Studienzentrum Aschaffenburg
Aschaffenburg, , Germany
Universitätsklinikum Augsburg
Augsburg, , Germany
Herz- und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen
Bad Oeynhausen, , Germany
Vivantes Netzwerk für Gesundheit GmbH
Berlin, , Germany
Ärztezentrum Helle Mitte
Berlin, , Germany
Klinikum Bielefeld gGmbH
Bielefeld, , Germany
Städtisches Klinikum Braunschweig gGmbH
Braunschweig, , Germany
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, , Germany
Universitätsklinikum Düsseldorf
Düsseldorf, , Germany
Agaplesion Markus Krankenhaus
Frankfurt, , Germany
ClinPhenomics GmbH & Co KG, Frankfurt
Frankfurt, , Germany
Nierenzentrum Freiburg
Freiburg im Breisgau, , Germany
Nephrologisches Zentrum Göttingen
Göttingen, , Germany
Universitätsklinikum Halle/S.
Halle, , Germany
Zentrum für Nieren-, Hochdruck und Stoffwechselerkrankungen
Hanover, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Dialysezentrum Heilbronn ÜBAG für Nephrologie und Dialyse
Heilbronn, , Germany
Nephrologisches Zentrum Hoyerswerda
Hoyerswerda, , Germany
Universitätsklinikum Jena
Jena, , Germany
Städt. Klinikum, Karlsruhe, Moltkestr.
Karlsruhe, , Germany
Klinikum St. Georg gGmbH
Leipzig, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, , Germany
Universitätsklinikum Mannheim GmbH
Mannheim, , Germany
Nephrologisches Zentrum Mettmann
Mettmann, , Germany
Klinikum der Universität München - Campus Innenstadt
München, , Germany
Dialysezentrum Neckarsulm
Neckarsulm, , Germany
KfH Kuratorium für Dialyse und Nierentransplantation e.V.
Nuremberg, , Germany
MVZ Diaverum Potsdam
Potsdam, , Germany
Universitätsklinikum Regensburg
Regensburg, , Germany
Robert-Bosch-Krankenhaus GmbH
Stuttgart, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
Nephrologisches Zentrum Velbert
Velbert, , Germany
MVZ DaVita Viersen GmbH
Viersen, , Germany
Nephrologisches Zentrum Villingen-Schwenningen
Villingen-Schwenningen, , Germany
Gemeinschaftspraxis für Nephrologie und Rheumatologie
Wiesbaden, , Germany
Universitätsklinikum Würzburg AÖR
Würzburg, , Germany
Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo
Alessandria, , Italy
A.O. Policlinico Giovanni XXIII di Bari
Bari, , Italy
Policlinico S. Orsola Malpighi
Bologna, , Italy
ASST degli Spedali Civili di Brescia
Brescia, , Italy
A. O. Ospedale Civile di Vimercate e Circolo di Desio
Desio, , Italy
Osp. S. Giovanni di Dio
Florence, , Italy
Ospedale S. Cuore di Gesù
Gallipoli, , Italy
Azienda Ospedaliera San Martino
Genova, , Italy
Ospedale della Versilia
LIDO DI Camaiore (LU), , Italy
A.O.U.Policlinico G.Martino
Messina, , Italy
Milano Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
Milan, , Italy
IRCCS San Raffaele
Milan, , Italy
AOU Università degli Studi della Campania Luigi Vanvitelli
Napoli, , Italy
Azienda Ospedaliera Universitaria di Padova
Padua, , Italy
A.O. Univ. Policlinico "Paolo Giaccone"
Palermo, , Italy
Poli Univ A. Gemelli
Roma, , Italy
Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
Roma, , Italy
IRCCS Ospedale "Casa Sollievo della Sofferenza"
SAN Giovanni Rotondo (FG), , Italy
Ospedale Ignazio Veris delli Ponti
Scorrano (LE), , Italy
Ospedale Martini
Torino, , Italy
A.O. Univ. Integrata di Verona
Verona, , Italy
Aichi Medical University Hospital
Aichi, , Japan
Chubu Rosai Hospital
Aichi, Nagoya, , Japan
Fukui Prefectural Hospital
Fukui, , Japan
Fukuoka University Hospital
Fukuoka, Fukuoka, , Japan
Joumou Ohashi Clinic
Gumma, Maebashi, , Japan
Maebashi Hirosegawa Clinic
Gunma, , Japan
Ota Diabetes Clinic
Gunma, , Japan
University of Tsukuba Hospital
Ibaraki, Tsukuba, , Japan
Medical Corporation Seijinkai Ikeda Hospital
Kagoshima, , Japan
Tokai University Hospital
Kanagawa, , Japan
Koukan Clinic
Kawasaki, , Japan
Kobe University Hospital
Kobe, , Japan
Tohoku University Hospital
Miyagi, Sendai, , Japan
Nagoya University Hospital
Nagoya, , Japan
Kawasaki Medical School Hospital
Okayama, Kurashiki, , Japan
Okayama University Hospital
Okayama, Okayama, , Japan
AMC Nishi-umeda Clinic
Osaka, , Japan
Kansai Electric Power Hospital
Osaka, , Japan
Iwasaki Internal Medicine Clinic
Osaka, , Japan
Shiga University of Medical Science Hospital
Shiga, Otsu, , Japan
Tokyo-Eki Center-building Clinic
Tokyo, , Japan
Juntendo University Hospital
Tokyo, Bunkyo-ku, , Japan
The University of Tokyo Hospital
Tokyo, Bunkyo-ku, , Japan
Shin Clinic
Tokyo, Ota-ku, , Japan
Center Hospital of the National Center for Global Health and Medicine
Tokyo, Shinjuku-ku, , Japan
Hospital Sultanah Bahiyah
Alor Setar, Kedah, , Malaysia
Hospital Ampang
Ampang, , Malaysia
University Kebangsaan Malaysia
Cheras, Kuala Lumpur, , Malaysia
Hospital Pulau Pinang
Georgetown, Pulau Pinang, , Malaysia
Hospital Raja Permaisuri Bainun
Ipoh, Perak, , Malaysia
Hospital Sultanah Aminah
Johor Bahru, , Malaysia
Hospital Kajang
Kajang, Selangor, , Malaysia
Hospital Serdang
Kajang, Selangor, , Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, , Malaysia
University of Malaya Medical Centre
Kuala Lumpur, , Malaysia
Hospital Selayang
Kuala Selangor, , Malaysia
Hospital Sultanah Nur Zahirah
Kuala Terengganu, , Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, , Malaysia
Sarawak General Hospital
Kuching, Sarawak, , Malaysia
Hospital Kulim
Kulim, Kedah, , Malaysia
Hospital Melaka
Malacca, , Malaysia
Hospital Pakar Sultanah Fatimah
Muar town, , Malaysia
Hospital Tuanku Ja'afar
Seremban, Negeri Sembilan, , Malaysia
Pusat Perubatan UiTM Jalan Hospital
Sungai Buloh, , Malaysia
Hospital Sultan Abdul Halim
Sungai Petani, , Malaysia
Hospital Taiping
Taiping, Perak, , Malaysia
Antrim Area Hospital
Antrim, , United Kingdom
Ulster Hospital
Belfast, , United Kingdom
Belfast City Hospital
Belfast, , United Kingdom
Queen Elizabeth Hospital
Birmingham, , United Kingdom
Oakenhurst Medical Practice
Blackburn, , United Kingdom
Royal Sussex County Hospital
Brighton, , United Kingdom
Southmead Hospital
Bristol, , United Kingdom
West Suffolk Hospital
Bury St Edmunds, , United Kingdom
Kent & Canterbury Hospital, Oncology Department, Canterbury
Canterbury, , United Kingdom
University Hospital of Wales
Cardiff, , United Kingdom
St Helier Hospital
Carshalton, , United Kingdom
Cheltenham General Hospital
Cheltenham, , United Kingdom
Hathaway Medical Centre
Chippenham, , United Kingdom
University Hospital Coventry
Coventry, , United Kingdom
Darent Valley Hospital, Chemotherapy Unit
Dartford, , United Kingdom
Royal Derby Hospital
Derby, , United Kingdom
Dorset County Hospital
Dorchester, , United Kingdom
Ninewells Hospital & Medical School
Dundee, , United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, , United Kingdom
Royal Devon and Exeter Hospital
Exeter, , United Kingdom
Queen Elizabeth University Hospital
Glasgow, , United Kingdom
Gloucestershire Royal Hospital
Gloucester, , United Kingdom
Hull Royal Infirmary
Hull, , United Kingdom
Ipswich Hospital
Ipswich, , United Kingdom
Queen Elizabeth Hospital
Kings Lynn, , United Kingdom
St James's University Hospital
Leeds, , United Kingdom
University Hospitals of Leicester
Leicester, , United Kingdom
Aintree University Hospital
Liverpool, , United Kingdom
The Royal London Hospital
London, , United Kingdom
North Middlesex Hospital
London, , United Kingdom
Royal Free Hospital
London, , United Kingdom
King's College Hospital
London, , United Kingdom
St George's Hospital
London, , United Kingdom
Hammersmith Hospital
London, , United Kingdom
Altnagelvin Area Hospital
Londonderry, , United Kingdom
Freeman Hospital
Newcastle, , United Kingdom
Daisy Hill Hospital
Newry, , United Kingdom
Norfolk and Norwich University Hospital
Norwich, , United Kingdom
Nottingham City Hospital
Nottingham, , United Kingdom
Churchill Hospital
Oxford, , United Kingdom
St Bartholomew's Medical Centre (OxFed)
Oxford, , United Kingdom
Derriford Hospital
Plymouth, , United Kingdom
Wessex Kidney Centre
Portsmouth, , United Kingdom
Royal Berkshire Hospital
Reading, , United Kingdom
Queen's Hospital
Romford, , United Kingdom
Salford Royal Hospital
Salford, , United Kingdom
Northern General Hospital
Sheffield, , United Kingdom
Lister Hospital
Stevenage, , United Kingdom
University Hospitals of North Midlands
Stoke-on-Trent, , United Kingdom
Great Western Hospital
Swindon, , United Kingdom
Princess Royal Hospital
Telford, , United Kingdom
Royal Cornwall Hospital
Truro, , United Kingdom
Walsall Manor Hospital
Walsall, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Uster A, Desai N, Navaneethan SD, Pfarr E, Mazo AR. Empagliflozin Reduces Risk of Hospitalization in Patients With Chronic Kidney Disease in the EMPA-KIDNEY Trial. Clin Ther. 2025 Oct 4:S0149-2918(25)00315-7. doi: 10.1016/j.clinthera.2025.09.005. Online ahead of print.
Zhou J, Williams C, Staplin N, Judge PK, Mayne KJ, Agrawal N, Arimoto R, Green JB, Cherney DZI, Tuttle KR, Leal J, Clarke P, Emberson JR, Preiss D, Wanner C, Landray MJ, Baigent C, Haynes R, Herrington WG, Mihaylova B; EMPA-KIDNEY Collaborative Group. Effects of empagliflozin on quality of life and healthcare use and costs in chronic kidney disease: a health economic analysis of the EMPA-KIDNEY trial. EClinicalMedicine. 2025 Jul 8;85:103338. doi: 10.1016/j.eclinm.2025.103338. eCollection 2025 Jul.
Oshima M, Buizen L, Jongs N, Levin A, Chertow GM, Wheeler DC, Heerspink HJL, Arnott C, Jardine MJ, Mahaffey KW, Pollock C, Herrington WG, Perkovic V, Neuen BL. Sodium-Glucose Cotransporter 2 Inhibition and Hospitalizations in Patients with CKD: A Meta-Analysis of Kidney Outcome Trials. Clin J Am Soc Nephrol. 2025 Jul 14;20(9):1206-1214. doi: 10.2215/CJN.0000000771.
Mayne KJ, Sardell RJ, Staplin N, Judge PK, Zhu D, Sammons E, Cherney DZI, Cheung AK, Maggioni AP, Nangaku M, Rossello X, Tuttle KR, Ihara K, Iwata T, Wanner C, Emberson J, Preiss D, Landray MJ, Baigent C, Haynes R, Herrington WG; EMPA-KIDNEY Collaborative Group. Frailty, Multimorbidity, and Polypharmacy: Exploratory Analyses of the Effects of Empagliflozin from the EMPA-KIDNEY Trial. Clin J Am Soc Nephrol. 2024 Sep 1;19(9):1119-1129. doi: 10.2215/CJN.0000000000000498. Epub 2024 Jun 27.
EMPA-KIDNEY Collaborative Group; Herrington WG, Staplin N, Agrawal N, Wanner C, Green JB, Hauske SJ, Emberson JR, Preiss D, Judge P, Zhu D, Dayanandan R, Arimoto R, Mayne KJ, Ng SYA, Sammons E, Hill M, Stevens W, Wallendszus K, Brenner S, Cheung AK, Liu ZH, Li J, Hooi LS, Liu W, Kadowaki T, Nangaku M, Levin A, Cherney DZI, Maggioni AP, Pontremoli R, Deo R, Goto S, Rossello X, Tuttle KR, Steubl D, Massey D, Brueckmann M, Landray MJ, Baigent C, Haynes R; EMPA-KIDNEY Collaborative Group. Long-Term Effects of Empagliflozin in Patients with Chronic Kidney Disease. N Engl J Med. 2025 Feb 20;392(8):777-787. doi: 10.1056/NEJMoa2409183. Epub 2024 Oct 25.
Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
Mayne KJ, Staplin N, Keane DF, Wanner C, Brenner S, Cejka V, Stegbauer J, Judge PK, Preiss D, Emberson J, Trinca D, Dayanandan R, Lee R, Nolan J, Omata A, Green JB, Cherney DZI, Hooi LS, Pontremoli R, Tuttle KR, Lees JS, Mark PB, Davies SJ, Hauske SJ, Steubl D, Bruckmann M, Landray MJ, Baigent C, Haynes R, Herrington WG; EMPA-KIDNEY Collaborative Group. Effects of Empagliflozin on Fluid Overload, Weight, and Blood Pressure in CKD. J Am Soc Nephrol. 2024 Feb 1;35(2):202-215. doi: 10.1681/ASN.0000000000000271. Epub 2023 Dec 12.
EMPA-KIDNEY Collaborative Group. Impact of primary kidney disease on the effects of empagliflozin in patients with chronic kidney disease: secondary analyses of the EMPA-KIDNEY trial. Lancet Diabetes Endocrinol. 2024 Jan;12(1):51-60. doi: 10.1016/S2213-8587(23)00322-4. Epub 2023 Dec 4.
EMPA-KIDNEY Collaborative Group. Effects of empagliflozin on progression of chronic kidney disease: a prespecified secondary analysis from the empa-kidney trial. Lancet Diabetes Endocrinol. 2024 Jan;12(1):39-50. doi: 10.1016/S2213-8587(23)00321-2. Epub 2023 Dec 4.
The EMPA-KIDNEY Collaborative Group; Herrington WG, Staplin N, Wanner C, Green JB, Hauske SJ, Emberson JR, Preiss D, Judge P, Mayne KJ, Ng SYA, Sammons E, Zhu D, Hill M, Stevens W, Wallendszus K, Brenner S, Cheung AK, Liu ZH, Li J, Hooi LS, Liu W, Kadowaki T, Nangaku M, Levin A, Cherney D, Maggioni AP, Pontremoli R, Deo R, Goto S, Rossello X, Tuttle KR, Steubl D, Petrini M, Massey D, Eilbracht J, Brueckmann M, Landray MJ, Baigent C, Haynes R. Empagliflozin in Patients with Chronic Kidney Disease. N Engl J Med. 2023 Jan 12;388(2):117-127. doi: 10.1056/NEJMoa2204233. Epub 2022 Nov 4.
Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.
Almaimani M, Sridhar VS, Cherney DZI. Sodium-glucose cotransporter 2 inhibition in non-diabetic kidney disease. Curr Opin Nephrol Hypertens. 2021 Sep 1;30(5):474-481. doi: 10.1097/MNH.0000000000000724.
Piperidou A, Loutradis C, Sarafidis P. SGLT-2 inhibitors and nephroprotection: current evidence and future perspectives. J Hum Hypertens. 2021 Jan;35(1):12-25. doi: 10.1038/s41371-020-00393-4. Epub 2020 Aug 10.
Gonzalez DE, Foresto RD, Ribeiro AB. SGLT-2 inhibitors in diabetes: a focus on renoprotection. Rev Assoc Med Bras (1992). 2020 Jan 13;66Suppl 1(Suppl 1):s17-s24. doi: 10.1590/1806-9282.66.S1.17.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol: EMPA-KIDNEY Clinical Trial Protocol
Document Type: Study Protocol: EMPA-KIDNEY Post-Trial Follow-Up Protocol
Document Type: Study Protocol: EMPA-KIDNEY MRI Sub-study Protocol
Document Type: Study Protocol: EMPA-KIDNEY BCM Sub-study Protocol
Document Type: Statistical Analysis Plan: EMPA-KIDNEY: Trial Statistical Analysis Plan
Document Type: Statistical Analysis Plan: EMPA-KIDNEY Post-Trial Follow-Up Data Analysis Plan
Document Type: Statistical Analysis Plan: EMPA-KIDNEY BCM sub-study Data Analysis Plan
Document Type: Statistical Analysis Plan: EMPA-KIDNEY MRI sub-study Data Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2017-002971-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1245-0137
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.