EMPA-KIDNEY (The Study of Heart and Kidney Protection With Empagliflozin)
A Multicentre International Randomized Parallel Group Double-blind Placebo-controlled Clinical Trial of EMPAgliflozin Once Daily to Assess Cardio-renal Outcomes in Patients With Chronic KIDNEY Disease
2 other identifiers
interventional
6,609
8 countries
240
Brief Summary
The primary aim of the study is to investigate the effect of empagliflozin on kidney disease progression or cardiovascular death versus placebo on top of standard of care in patients with pre-existing chronic kidney disease. After completion of the interventional part of the study (primary study completion) a subset of participants will be followed up in a post-trial observational (non-interventional) manner for cardio-renal outcomes (estimated study completion date).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2019
Longer than P75 for phase_3
240 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2018
CompletedFirst Posted
Study publicly available on registry
July 20, 2018
CompletedStudy Start
First participant enrolled
January 31, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 5, 2022
CompletedResults Posted
Study results publicly available
July 27, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 2, 2024
CompletedJuly 20, 2025
June 1, 2025
3.4 years
July 10, 2018
June 30, 2023
June 30, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Interventional Part: Time to First Occurrence of Kidney Disease Progression or Cardiovascular Death ('as Adjudicated')
Time to first occurrence of kidney disease progression (KDP) or cardiovascular death is reported as incidence rate of first occurrence of KDP or adjudicated cardiovascular death. Incidence rate= (Number of patients who experienced the event of first occurrence of KDP or cardiovascular death)\*100/(patient years at risk (pt-yrs at risk). pt-yrs at risk= sum of time at risk \[days\] over all patients in a treatment group / 365.25. Kidney disease progression was defined as: * end stage kidney disease (defined as the initiation of maintenance dialysis or receipt of a kidney transplant) OR * a sustained decline in estimated glomerular filtration rate (eGFR) to \<10 mL/min/1.73m\^2 OR * renal death OR * a sustained decline of ≥40% in eGFR from randomisation.
From the day of randomisation to the day of the final follow-up visit in the interventional part of the trial, up to 1136 days.
Overall Study: Time to the First Occurrence of Kidney Disease Progression or Cardiovascular Death ('as Adjudicated')
Time to first occurrence of kidney disease progression (KDP) or cardiovascular death is reported as incidence of progression of kidney disease or death from cardiovascular causes in the interventional part of the trial and in the post-trial follow-up (non-interventional part). Incidence rate= (Number of patients who experienced the event of first occurrence of KDP or cardiovascular death)\*100/(patient years at risk (pt-yrs at risk). pt-yrs at risk= sum of time at risk \[days\] over all patients in a treatment group / 365.25. Kidney disease progression was defined as: * a sustained decline in eGFR to less than 10 mL/min/1.73m\^2 OR * renal death OR * sustained decline of more than 40% in eGFR from randomization.
From the day of randomization in the interventional part of the trial until the individual day of end of study in the non-interventional part of the trial. Up to 1869 days.
Secondary Outcomes (11)
Key Secondary Endpoint: Interventional Part - Time to First Hospitalization for Heart Failure ('as Adjudicated') or Cardiovascular Death ('as Adjudicated')
From the day of randomisation to the day of the final follow-up visit of the interventional part, up to 1140 days.
Key Secondary Endpoint: Interventional Part - Time to Occurrences of All-cause Hospitalizations (First and Recurrent Combined)
From the day of randomisation to the day of the final follow-up visit of the interventional part, up to 1140 days.
Key Secondary Endpoint: Interventional Part - Time to Death From Any Cause ('as Adjudicated')
From the day of randomisation to the day of the final follow-up visit in the interventional part of the trial, up to 1140 days.
Interventional Part: Time to First Occurrence of Kidney Disease Progression
From the day of randomisation to the day of the final follow-up visit of the interventional part, up to 1136 days.
Interventional Part: Time to Cardiovascular Death ('as Adjudicated')
From the day of randomisation to the day of the final follow-up visit of the interventional part, up to 1140 days.
- +6 more secondary outcomes
Study Arms (2)
Empagliflozin 10 mg
EXPERIMENTALPatients 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.
Placebo
PLACEBO COMPARATORPatients 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.
Interventions
Eligibility Criteria
You may qualify if:
- Age ≥18 years or at "full age" as required by local regulation
- 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;
You may not qualify if:
- Currently receiving SGLT-2 or SGLT-1/2 inhibitor
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boehringer Ingelheimlead
- University of Oxfordcollaborator
- Eli Lilly and Companycollaborator
Study Sites (240)
Nephrology Consultants, LLC
Huntsville, Alabama, 35805, United States
Aventiv Research, Inc
Mesa, Arizona, 85210, United States
Southern California Permanente Medical Group
San Diego, California, 92123, United States
University of California Los Angeles
Sylmar, California, 91342, United States
University of California Los Angeles
Torrance, California, 90502, United States
Yale University School of Medicine
New Haven, Connecticut, 06510, United States
Chase Medical Research, LLC
Thomaston, Connecticut, 06787, United States
Midland Florida Clinical Reearch Center, LLC
DeLand, Florida, 32720, United States
University of Florida
Gainesville, Florida, 32610, United States
East Coast Institute for Research, LLC
Jacksonville, Florida, 32216, United States
East Coast Clinical Research, Inc
Lake City, Florida, 32055, United States
Total Research Group, LLC
Miami, Florida, 33126, United States
Hanson Clinical Research Center, Inc.
Port Charlotte, Florida, 33952, United States
Emory University
Atlanta, Georgia, 30322, United States
The Jones Center for Diabetes and Endocrine Wellness
Macon, Georgia, 31210, United States
Cedar Crosse Research Center
Chicago, Illinois, 60607, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Saint Elizabeth Healthcare
Covington, Kentucky, 41011, United States
Lexington VA Health Care System - Troy Bowling Campus
Lexington, Kentucky, 40502, United States
Medstar Health Research Institute
Baltimore, Maryland, 21239, United States
Kidney Care and Transplant Services of New England, PC
West Springfield, Massachusetts, 01089, United States
Saint Clair Specialty Physicians
Roseville, Michigan, 48066, United States
Clinical Research Consultants, LLC
Kansas City, Missouri, 64111, United States
VA Southern Nevada Healthcare System
North Las Vegas, Nevada, 89086, United States
Seacoast Kidney and Hypertension Specialists
Portsmouth, New Hampshire, 03801, United States
SUNY Downstate Medical Center
Brooklyn, New York, 11203, United States
Mountain Kidney and Hypertension Associates, PA
Asheville, North Carolina, 28801, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514, United States
Brookview Hills Research Associates LLC
Winston-Salem, North Carolina, 27103, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19114, United States
Carolina Diabetes & Kidney Center
Sumter, South Carolina, 29150, United States
Regional Health Clinical Research
Rapid City, South Dakota, 57701, United States
Research Institute of Dallas
Dallas, Texas, 75231, United States
Renal Disease Research Institute
Dallas, Texas, 75246, United States
Academy Of Diabetes, Thyroid And Endocrine, PA
El Paso, Texas, 79935, United States
Pioneer Research Solutions, Inc.
Houston, Texas, 77099, United States
P&I Clinical Research, LLC
Lufkin, Texas, 75904, United States
Texas Institute for Kidney and Endocrine Disorders
Lufkin, Texas, 75904, United States
Clinical Advancement Center PLLC
San Antonio, Texas, 78212, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, 84108, United States
Salem VA Medical Center
Salem, Virginia, 24153, United States
Providence Medical Research Center
Spokane, Washington, 99204, United States
Kelowna General Hospital
Kelowna, British Columbia, V1Y 1T2, Canada
Kidney Care Centre - Surrey
Surrey, British Columbia, V3T 5H6, Canada
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6, Canada
LMC Clinical Research Inc. (Brampton)
Brampton, Ontario, L6S 0C6, Canada
Cambridge Cardiac Care Centre
Cambridge, Ontario, N1R 6V6, Canada
LMC Clinical Research Inc. (Thornhill)
Concord, Ontario, L4K 4M2, Canada
LMC Endocrinology Centres (Etobicoke) Ltd.
Etobicoke, Ontario, M9R 4E1, Canada
London Health Science Centre, University Campus
London, Ontario, N6A 4G5, Canada
LMC Clinical Research Inc. (Ottawa)
Nepean, Ontario, K2J 0V2, Canada
Lakeridge Health Oshawa
Oshawa, Ontario, L1G 2B9, Canada
LMC Clinical Research Inc. (Bayview)
Toronto, Ontario, M4G 3E8, Canada
Toronto General Hospital
Toronto, Ontario, M5G 2N2, Canada
Fadia El Boreky Medicine Professional
Waterloo, Ontario, N2J 1C4, Canada
Clinical Research Solutions Inc.
Waterloo, Ontario, N2J 3Z4, Canada
Montreal Clinical Research Institute (IRCM)
Montreal, Quebec, H2W 1R7, Canada
Hôpital du Sacré-Coeur de Montréal
Montreal, Quebec, H4J 1C5, Canada
CHUS Hopital Fleurimont
Sherbrooke, Quebec, J1H 5N4, Canada
CHU de Quebec-Universite Laval Research Centre
Québec, G1R 2J6, Canada
IUCPQ (Laval University)
Québec, G1V 4G5, Canada
Beijing AnZhen Hospital
Beijing, 100029, China
Cardiovascular Institute and Fu Wai Hospital
Beijing, 100037, China
Xiangya Hospital, Central South University
Changsha, 410008, China
Xinqiao Hospital
Chongqing, 400037, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, 310000, China
Jinzhou Central Hospital
Jinzhou, 121000, China
Jinling Hospital
Nanjing, 210002, China
Shanghai Fifth People's Hospital affiliated to Fudan University
Shanghai, 200240, China
Shenzhen People's Hospital
Shenzhen, 518020, China
Huazhong University of Science and Technology Union Shenzhen Hospital
Shenzhen, 518052, China
People's Hospital of Sichuan Province
Sichuan, 610031, China
SuZhou Kowloon Hospital
Suzhou, 215000, China
The Central Hospital of Wuhan
Wuhan, 430014, China
Wuhan Fourth Hospital
Wuhan, 430033, China
Henan Provincial People's Hospital
Zhengzhou, 450003, China
Zhuzhou Central Hospital
Zhuzhou, 412000, China
Zhuzhou Central Hospital
Zhuzhou, 412007, China
Studienzentrum Aschaffenburg
Aschaffenburg, 63739, Germany
Universitätsklinikum Augsburg
Augsburg, 86156, Germany
Herz- und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen
Bad Oeynhausen, 32545, Germany
Vivantes Netzwerk fĂ¼r Gesundheit GmbH
Berlin, 12351, Germany
Ă„rztezentrum Helle Mitte
Berlin, 12627, Germany
Klinikum Bielefeld gGmbH
Bielefeld, 33604, Germany
Städtisches Klinikum Braunschweig gGmbH
Braunschweig, 38126, Germany
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, 01307, Germany
Universitätsklinikum DĂ¼sseldorf
DĂ¼sseldorf, 40225, Germany
Agaplesion Markus Krankenhaus
Frankfurt, 60431, Germany
ClinPhenomics GmbH & Co KG, Frankfurt
Frankfurt, 60594, Germany
Nierenzentrum Freiburg
Freiburg im Breisgau, 79100, Germany
Nephrologisches Zentrum Göttingen
Göttingen, 37075, Germany
Universitätsklinikum Halle/S.
Halle, 06120, Germany
Zentrum fĂ¼r Nieren-, Hochdruck und Stoffwechselerkrankungen
Hanover, 30453, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Dialysezentrum Heilbronn ĂœBAG fĂ¼r Nephrologie und Dialyse
Heilbronn, 74075, Germany
Nephrologisches Zentrum Hoyerswerda
Hoyerswerda, 02977, Germany
Universitätsklinikum Jena
Jena, 07747, Germany
Städt. Klinikum, Karlsruhe, Moltkestr.
Karlsruhe, 76133, Germany
Klinikum St. Georg gGmbH
Leipzig, 04129, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131, Germany
Universitätsklinikum Mannheim GmbH
Mannheim, 68167, Germany
Nephrologisches Zentrum Mettmann
Mettmann, 40822, Germany
Klinikum der Universität MĂ¼nchen - Campus Innenstadt
MĂ¼nchen, 80337, Germany
Dialysezentrum Neckarsulm
Neckarsulm, 74172, Germany
KfH Kuratorium fĂ¼r Dialyse und Nierentransplantation e.V.
Nuremberg, 90471, Germany
MVZ Diaverum Potsdam
Potsdam, 14469, Germany
Universitätsklinikum Regensburg
Regensburg, 93053, Germany
Robert-Bosch-Krankenhaus GmbH
Stuttgart, 70376, Germany
Universitätsklinikum Ulm
Ulm, 89081, Germany
Nephrologisches Zentrum Velbert
Velbert, 42549, Germany
MVZ DaVita Viersen GmbH
Viersen, 41751, Germany
Nephrologisches Zentrum Villingen-Schwenningen
Villingen-Schwenningen, 78052, Germany
Gemeinschaftspraxis fĂ¼r Nephrologie und Rheumatologie
Wiesbaden, 65191, Germany
Universitätsklinikum WĂ¼rzburg AĂ–R
WĂ¼rzburg, 97080, Germany
Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo
Alessandria, 15121, Italy
A.O. Policlinico Giovanni XXIII di Bari
Bari, 70124, Italy
Policlinico S. Orsola Malpighi
Bologna, 40138, Italy
ASST degli Spedali Civili di Brescia
Brescia, 25123, Italy
A. O. Ospedale Civile di Vimercate e Circolo di Desio
Desio, 20832, Italy
Osp. S. Giovanni di Dio
Florence, 50143, Italy
Ospedale S. Cuore di GesĂ¹
Gallipoli, 73014, Italy
Azienda Ospedaliera San Martino
Genova, 16132, Italy
Ospedale della Versilia
LIDO DI Camaiore (LU), 55043, Italy
A.O.U.Policlinico G.Martino
Messina, 98124, Italy
Milano Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
Milan, 20122, Italy
IRCCS San Raffaele
Milan, 20132, Italy
AOU UniversitĂ degli Studi della Campania Luigi Vanvitelli
Napoli, 80138, Italy
Azienda Ospedaliera Universitaria di Padova
Padua, 35128, Italy
A.O. Univ. Policlinico "Paolo Giaccone"
Palermo, 90127, Italy
Poli Univ A. Gemelli
Roma, 00168, Italy
Azienda Ospedaliera Sant'Andrea-UniversitĂ di Roma La Sapienza
Roma, 00189, Italy
IRCCS Ospedale "Casa Sollievo della Sofferenza"
SAN Giovanni Rotondo (FG), 71013, Italy
Ospedale Ignazio Veris delli Ponti
Scorrano (LE), 73020, Italy
Ospedale Martini
Torino, 10141, Italy
A.O. Univ. Integrata di Verona
Verona, 37126, Italy
Aichi Medical University Hospital
Aichi, 480-1195, Japan
Chubu Rosai Hospital
Aichi, Nagoya, 455-8530, Japan
Fukui Prefectural Hospital
Fukui, 910-8526, Japan
Fukuoka University Hospital
Fukuoka, Fukuoka, 814-0180, Japan
Joumou Ohashi Clinic
Gumma, Maebashi, 371-0046, Japan
Maebashi Hirosegawa Clinic
Gunma, 371-0022, Japan
Ota Diabetes Clinic
Gunma, 373-0861, Japan
University of Tsukuba Hospital
Ibaraki, Tsukuba, 305-8576, Japan
Medical Corporation Seijinkai Ikeda Hospital
Kagoshima, 893-0024, Japan
Tokai University Hospital
Kanagawa, 259-1193, Japan
Koukan Clinic
Kawasaki, 210-0852, Japan
Kobe University Hospital
Kobe, 650-0017, Japan
Tohoku University Hospital
Miyagi, Sendai, 980-8547, Japan
Nagoya University Hospital
Nagoya, 466-8560, Japan
Kawasaki Medical School Hospital
Okayama, Kurashiki, 701-0192, Japan
Okayama University Hospital
Okayama, Okayama, 700-8558, Japan
AMC Nishi-umeda Clinic
Osaka, 530-0001, Japan
Kansai Electric Power Hospital
Osaka, 553-0003, Japan
Iwasaki Internal Medicine Clinic
Osaka, 577-0802, Japan
Shiga University of Medical Science Hospital
Shiga, Otsu, 520-2192, Japan
Tokyo-Eki Center-building Clinic
Tokyo, 103-0027, Japan
Juntendo University Hospital
Tokyo, Bunkyo-ku, 113-8431, Japan
The University of Tokyo Hospital
Tokyo, Bunkyo-ku, 113-8655, Japan
Shin Clinic
Tokyo, Ota-ku, 144-0051, Japan
Center Hospital of the National Center for Global Health and Medicine
Tokyo, Shinjuku-ku, 162-8555, Japan
Hospital Sultanah Bahiyah
Alor Setar, Kedah, 05460, Malaysia
Hospital Ampang
Ampang, 68000, Malaysia
University Kebangsaan Malaysia
Cheras, Kuala Lumpur, 56000, Malaysia
Hospital Pulau Pinang
Georgetown, Pulau Pinang, 10450, Malaysia
Hospital Raja Permaisuri Bainun
Ipoh, Perak, 30450, Malaysia
Hospital Sultanah Aminah
Johor Bahru, 80100, Malaysia
Hospital Kajang
Kajang, Selangor, 43000, Malaysia
Hospital Serdang
Kajang, Selangor, 43000, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, 50586, Malaysia
University of Malaya Medical Centre
Kuala Lumpur, 59100, Malaysia
Hospital Selayang
Kuala Selangor, 68100, Malaysia
Hospital Sultanah Nur Zahirah
Kuala Terengganu, 20400, Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, 25100, Malaysia
Sarawak General Hospital
Kuching, Sarawak, 93586, Malaysia
Hospital Kulim
Kulim, Kedah, 9000, Malaysia
Hospital Melaka
Malacca, 75400, Malaysia
Hospital Pakar Sultanah Fatimah
Muar town, 84000, Malaysia
Hospital Tuanku Ja'afar
Seremban, Negeri Sembilan, 70300, Malaysia
Pusat Perubatan UiTM Jalan Hospital
Sungai Buloh, 47000, Malaysia
Hospital Sultan Abdul Halim
Sungai Petani, 8000, Malaysia
Hospital Taiping
Taiping, Perak, 34000, Malaysia
Antrim Area Hospital
Antrim, BT41 2RL, United Kingdom
Ulster Hospital
Belfast, BT16 1RH, United Kingdom
Belfast City Hospital
Belfast, BT9 7AB, United Kingdom
Queen Elizabeth Hospital
Birmingham, B15 2TH, United Kingdom
Oakenhurst Medical Practice
Blackburn, BB2 1AX, United Kingdom
Royal Sussex County Hospital
Brighton, BN2 5BE, United Kingdom
Southmead Hospital
Bristol, BS10 5NB, United Kingdom
West Suffolk Hospital
Bury St Edmunds, IP33 2QZ, United Kingdom
Kent & Canterbury Hospital, Oncology Department, Canterbury
Canterbury, CT1 3NG, United Kingdom
University Hospital of Wales
Cardiff, CF14 4XW, United Kingdom
St Helier Hospital
Carshalton, SM5 1AA, United Kingdom
Cheltenham General Hospital
Cheltenham, GL53 7AN, United Kingdom
Hathaway Medical Centre
Chippenham, SN14 6GT, United Kingdom
University Hospital Coventry
Coventry, CV2 2DX, United Kingdom
Darent Valley Hospital, Chemotherapy Unit
Dartford, DA2 8DA, United Kingdom
Royal Derby Hospital
Derby, DE22 3NE, United Kingdom
Dorset County Hospital
Dorchester, DT1 2JY, United Kingdom
Ninewells Hospital & Medical School
Dundee, DD1 9SY, United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA, United Kingdom
Royal Devon and Exeter Hospital
Exeter, EX2 5DW, United Kingdom
Queen Elizabeth University Hospital
Glasgow, G51 4TF, United Kingdom
Gloucestershire Royal Hospital
Gloucester, GL1 3NN, United Kingdom
Hull Royal Infirmary
Hull, HU3 2JZ, United Kingdom
Ipswich Hospital
Ipswich, IP4 5PD, United Kingdom
Queen Elizabeth Hospital
Kings Lynn, PE30 4ET, United Kingdom
St James's University Hospital
Leeds, LS9 7TF, United Kingdom
University Hospitals of Leicester
Leicester, LE5 4PW, United Kingdom
Aintree University Hospital
Liverpool, L9 7AL, United Kingdom
The Royal London Hospital
London, E1 1BB, United Kingdom
North Middlesex Hospital
London, N18 1QX, United Kingdom
Royal Free Hospital
London, NW3 2QG, United Kingdom
King's College Hospital
London, SE5 9RS, United Kingdom
St George's Hospital
London, SW17 0QT, United Kingdom
Hammersmith Hospital
London, W12 0HS, United Kingdom
Altnagelvin Area Hospital
Londonderry, BT47 6SB, United Kingdom
Freeman Hospital
Newcastle, NE7 7DN, United Kingdom
Daisy Hill Hospital
Newry, BT35 8DR, United Kingdom
Norfolk and Norwich University Hospital
Norwich, NR4 7UY, United Kingdom
Nottingham City Hospital
Nottingham, NG5 1PB, United Kingdom
Churchill Hospital
Oxford, OX3 7LE, United Kingdom
St Bartholomew's Medical Centre (OxFed)
Oxford, OX3 9RF, United Kingdom
Derriford Hospital
Plymouth, PL6 5FP, United Kingdom
Wessex Kidney Centre
Portsmouth, PO6 3LY, United Kingdom
Royal Berkshire Hospital
Reading, RG1 5AN, United Kingdom
Queen's Hospital
Romford, RM7 0AG, United Kingdom
Salford Royal Hospital
Salford, M6 8HD, United Kingdom
Northern General Hospital
Sheffield, S5 7AU, United Kingdom
Lister Hospital
Stevenage, SG1 4AB, United Kingdom
University Hospitals of North Midlands
Stoke-on-Trent, ST4 6QG, United Kingdom
Great Western Hospital
Swindon, SN3 6BB, United Kingdom
Princess Royal Hospital
Telford, TF1 6TF, United Kingdom
Royal Cornwall Hospital
Truro, TR1 3LQ, United Kingdom
Walsall Manor Hospital
Walsall, WS2 9PS, United Kingdom
Related Publications (15)
Mottl A, Scott C, Green JB, Heerspink HJL, Mann JFE, McGill JB, Nangaku M, Rosenstock J, Rossing P, Li L, Li N, Vaduganathan M, Agarwal R; CONFIDENCE Trial Investigators. Baseline Kidney Function, Albuminuria, and Urine Albumin-Creatinine Ratio Reduction with Finerenone, Empagliflozin, or Both: Post Hoc Analyses of CONFIDENCE Trial. J Am Soc Nephrol. 2025 Nov 6. doi: 10.1681/ASN.0000000928. Online ahead of print. No abstract available.
PMID: 41196655DERIVEDUster 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 Dec;47(12):1091-1096. doi: 10.1016/j.clinthera.2025.09.005. Epub 2025 Oct 4.
PMID: 41047325DERIVEDZhou 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.
PMID: 40686671DERIVEDOshima 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.
PMID: 40658498DERIVEDMayne 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.
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Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Center
- Organization
- Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2018
First Posted
July 20, 2018
Study Start
January 31, 2019
Primary Completion
July 5, 2022
Study Completion
July 2, 2024
Last Updated
July 20, 2025
Results First Posted
July 27, 2023
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
- Access Criteria
- For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.