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

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).

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Drug: Empagliflozin; Drug: Matching placebo

• Study Type: Interventional
• Enrollment (Actual): 6609
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1R 2J6
    • CHU de Quebec-Universite Laval Research Centre
  • Quebec, Canada, G1V 4G5
    • IUCPQ (Laval University)
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 1T2
      • Kelowna General Hospital
    • Surrey, British Columbia, Canada, V3T 5H6
      • Kidney Care Centre - Surrey
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • St. Paul's Hospital
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver General Hospital
  • Ontario
    • Brampton, Ontario, Canada, L6S 0C6
      • LMC Clinical Research Inc. (Brampton)
    • Cambridge, Ontario, Canada, N1R 6V6
      • Cambridge Cardiac Care Centre
    • Concord, Ontario, Canada, L4K 4M2
      • LMC Clinical Research Inc. (Thornhill)
    • Etobicoke, Ontario, Canada, M9R 4E1
      • LMC Endocrinology Centres (Etobicoke) Ltd.
    • London, Ontario, Canada, N6A 4G5
      • London Health Science Centre, University Campus
    • Nepean, Ontario, Canada, K2J 0V2
      • LMC Clinical Research Inc. (Ottawa)
    • Oshawa, Ontario, Canada, L1G 2B9
      • Lakeridge Health Oshawa
    • Toronto, Ontario, Canada, M5G 2N2
      • Toronto General Hospital
    • Toronto, Ontario, Canada, M4G 3E8
      • LMC Clinical Research Inc. (Bayview)
    • Waterloo, Ontario, Canada, N2J 1C4
      • Fadia El Boreky Medicine Professional
    • Waterloo, Ontario, Canada, N2J 3Z4
      • Clinical Research Solutions Inc.
  • Quebec
    • Montreal, Quebec, Canada, H4J 1C5
      • Hopital Du Sacre-Coeur de Montreal
    • Montreal, Quebec, Canada, H2W 1R7
      • Montreal Clinical Research Institute (IRCM)
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • CHUS Hopital Fleurimont
• China
  • Beijing, China, 100029
    • Beijing Anzhen Hospital
  • Beijing, China, 100037
    • Cardiovascular Institute and Fu Wai Hospital
  • Changsha, China, 410008
    • Xiangya Hospital, Central South University
  • Chongqing, China, 400037
    • Xinqiao Hospital
  • Hangzhou, China, 310000
    • The Second Affiliated Hospital Zhejiang University School of Medicine
  • Jinzhou, China, 121000
    • Jinzhou Central Hospital
  • Nanjing, China, 210002
    • Jinling Hospital
  • Shanghai, China, 200240
    • Shanghai Fifth People's Hospital affiliated to Fudan University
  • Shenzhen, China, 518020
    • ShenZhen People's Hospital
  • Shenzhen, China, 518052
    • Huazhong University of Science and Technology Union Shenzhen Hospital
  • Sichuan, China, 610031
    • People's Hospital of Sichuan Province
  • Suzhou, China, 215000
    • SuZhou Kowloon Hospital
  • Wuhan, China, 430014
    • The Central Hospital of Wuhan
  • Wuhan, China, 430033
    • Wuhan Fourth Hospital
  • Zhengzhou, China, 450003
    • Henan Provincial People's Hospital
  • Zhuzhou, China, 412000
    • ZhuZhou Central Hospital
  • Zhuzhou, China, 412007
    • ZhuZhou Central Hospital
• Germany
  • Aschaffenburg, Germany, 63739
    • Studienzentrum Aschaffenburg
  • Augsburg, Germany, 86156
    • Universitätsklinikum Augsburg
  • Bad Oeynhausen, Germany, 32545
    • Herz- und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen
  • Berlin, Germany, 12351
    • Vivantes Netzwerk für Gesundheit GmbH
  • Berlin, Germany, 12627
    • Ärztezentrum Helle Mitte
  • Bielefeld, Germany, 33604
    • Klinikum Bielefeld gGmbH
  • Braunschweig, Germany, 38126
    • Städtisches Klinikum Braunschweig gGmbH
  • Dresden, Germany, 01307
    • Universitätsklinikum Carl Gustav Carus Dresden
  • Düsseldorf, Germany, 40225
    • Universitätsklinikum Düsseldorf
  • Frankfurt, Germany, 60431
    • Agaplesion Markus Krankenhaus
  • Frankfurt, Germany, 60594
    • ClinPhenomics GmbH & Co KG, Frankfurt
  • Freiburg, Germany, 79100
    • Nierenzentrum Freiburg
  • Göttingen, Germany, 37075
    • Nephrologisches Zentrum Göttingen
  • Halle, Germany, 06120
    • Universitätsklinikum Halle/S.
  • Hannover, Germany, 30453
    • Zentrum für Nieren-, Hochdruck und Stoffwechselerkrankungen
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Heilbronn, Germany, 74075
    • Dialysezentrum Heilbronn ÜBAG für Nephrologie und Dialyse
  • Hoyerswerda, Germany, 02977
    • Nephrologisches Zentrum Hoyerswerda
  • Jena, Germany, 07747
    • Universitatsklinikum Jena
  • Karlsruhe, Germany, 76133
    • Städt. Klinikum, Karlsruhe, Moltkestr.
  • Leipzig, Germany, 04129
    • Klinikum St. Georg gGmbH
  • Mainz, Germany, 55131
    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  • Mannheim, Germany, 68167
    • Universitätsklinikum Mannheim GmbH
  • Mettmann, Germany, 40822
    • Nephrologisches Zentrum Mettmann
  • München, Germany, 80337
    • Klinikum der Universität München - Campus Innenstadt
  • Neckarsulm, Germany, 74172
    • Dialysezentrum Neckarsulm
  • Nürnberg, Germany, 90471
    • KfH Kuratorium für Dialyse und Nierentransplantation e.V.
  • Potsdam, Germany, 14469
    • MVZ Diaverum Potsdam
  • Regensburg, Germany, 93053
    • Universitätsklinikum Regensburg
  • Stuttgart, Germany, 70376
    • Robert-Bosch-Krankenhaus GmbH
  • Ulm, Germany, 89081
    • Universitatsklinikum Ulm
  • Velbert, Germany, 42549
    • Nephrologisches Zentrum Velbert
  • Viersen, Germany, 41751
    • MVZ DaVita Viersen GmbH
  • Villingen-Schwenningen, Germany, 78052
    • Nephrologisches Zentrum Villingen-Schwenningen
  • Wiesbaden, Germany, 65191
    • Gemeinschaftspraxis für Nephrologie und Rheumatologie
  • Würzburg, Germany, 97080
    • Universitätsklinikum Würzburg AÖR
• Italy
  • Alessandria, Italy, 15121
    • Azienda ospedaliera Santi Antonio e Biagio e Cesare Arrigo
  • Bari, Italy, 70124
    • A.O. Policlinico Giovanni XXIII di Bari
  • Bologna, Italy, 40138
    • Policlinico S. Orsola Malpighi
  • Brescia, Italy, 25123
    • Asst Degli Spedali Civili Di Brescia
  • Desio, Italy, 20832
    • A. O. Ospedale Civile di Vimercate e Circolo di Desio
  • Firenze, Italy, 50143
    • Osp. S. Giovanni di Dio
  • Gallipoli, Italy, 73014
    • Ospedale S. Cuore di Gesù
  • Genova, Italy, 16132
    • Azienda Ospedaliera San Martino
  • LIDO DI Camaiore (LU), Italy, 55043
    • Ospedale della Versilia
  • Messina, Italy, 98124
    • A.O.U.Policlinico G.Martino
  • Milano, Italy, 20122
    • Milano Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
  • Milano, Italy, 20132
    • IRCCS San Raffaele
  • Napoli, Italy, 80138
    • AOU Università degli Studi della Campania Luigi Vanvitelli
  • Padova, Italy, 35128
    • Azienda Ospedaliera Universitaria Di Padova
  • Palermo, Italy, 90127
    • A.O. Univ. Policlinico "Paolo Giaccone"
  • Roma, Italy, 00189
    • Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
  • Roma, Italy, 00168
    • Poli Univ A. Gemelli
  • SAN Giovanni Rotondo (FG), Italy, 71013
    • IRCCS Ospedale "Casa Sollievo della Sofferenza"
  • Scorrano (LE), Italy, 73020
    • Ospedale Ignazio Veris delli Ponti
  • Torino, Italy, 10141
    • Ospedale Martini
  • Verona, Italy, 37126
    • A.O. Univ. Integrata di Verona
• Japan
  • Aichi, Japan, 480-1195
    • Aichi Medical University Hospital
  • Aichi, Nagoya, Japan, 455-8530
    • Chubu Rosai Hospital
  • Fukui City, Japan, 910-8526
    • Fukui Prefectural Hospital
  • Fukuoka, Fukuoka, Japan, 814-0180
    • Fukuoka University Hospital
  • Gumma, Maebashi, Japan, 371-0046
    • Joumou Ohashi Clinic
  • Gunma, Japan, 371-0022
    • Maebashi Hirosegawa Clinic
  • Gunma, Japan, 373-0861
    • Ota Diabetes Clinic
  • Ibaraki, Tsukuba, Japan, 305-8576
    • University of Tsukuba Hospital
  • Kagoshima, Japan, 893-0024
    • Medical Corporation Seijinkai Ikeda Hospital
  • Kanagawa, Japan, 259-1193
    • Tokai University Hospital
  • Kawasaki, Japan, 210-0852
    • Koukan Clinic
  • Kobe, Japan, 650-0017
    • Kobe University Hospital
  • Miyagi, Sendai, Japan, 980-8547
    • Tohoku University Hospital
  • Nagoya, Japan, 466-8560
    • Nagoya University Hospital
  • Okayama, Kurashiki, Japan, 701-0192
    • Kawasaki Medical School Hospital
  • Okayama, Okayama, Japan, 700-8558
    • Okayama University Hospital
  • Osaka, Japan, 530-0001
    • AMC Nishi-umeda Clinic
  • Osaka, Japan, 553-0003
    • Kansai Electric Power Hospital
  • Osaka, Japan, 577-0802
    • Iwasaki Internal Medicine Clinic
  • Shiga, Otsu, Japan, 520-2192
    • Shiga University of Medical Science Hospital
  • Tokyo, Japan, 103-0027
    • Tokyo-Eki Center-building Clinic
  • Tokyo, Bunkyo-ku, Japan, 113-8431
    • Juntendo University Hospital
  • Tokyo, Bunkyo-ku, Japan, 113-8655
    • The University of Tokyo Hospital
  • Tokyo, Ota-ku, Japan, 144-0051
    • Shin Clinic
  • Tokyo, Shinjuku-ku, Japan, 162-8555
    • Center Hospital of the National Center for Global Health and Medicine
• Malaysia
  • Alor Setar, Kedah, Malaysia, 05460
    • Hospital Sultanah Bahiyah
  • Ampang, Malaysia, 68000
    • Hospital Ampang
  • Cheras, Kuala Lumpur, Malaysia, 56000
    • University Kebangsaan Malaysia
  • Georgetown, Pulau Pinang, Malaysia, 10450
    • Hospital Pulau Pinang
  • Ipoh, Perak, Malaysia, 30450
    • Hospital Raja Permaisuri Bainun
  • Johor Bahru, Malaysia, 80100
    • Hospital Sultanah Aminah
  • Kajang, Selangor, Malaysia, 43000
    • Hospital Kajang
  • Kajang, Selangor, Malaysia, 43000
    • Hospital Serdang
  • Kuala Lumpur, Malaysia, 50586
    • Hospital Kuala Lumpur
  • Kuala Lumpur, Malaysia, 59100
    • University of Malaya Medical Centre
  • Kuala Trengganu, Malaysia, 20400
    • Hospital Sultanah Nur Zahirah
  • Kuantan, Malaysia, 25100
    • Hospital Tengku Ampuan Afzan
  • Kuching, Sarawak, Malaysia, 93586
    • Sarawak General Hospital
  • Kulim, Kedah, Malaysia, 9000
    • Hospital Kulim
  • Melaka, Malaysia, 75400
    • Hospital Melaka
  • Muar, Malaysia, 84000
    • Hospital Pakar Sultanah Fatimah
  • Selangor, Malaysia, 68100
    • Hospital Selayang
  • Seremban, Negeri Sembilan, Malaysia, 70300
    • Hospital Tuanku Ja'afar
  • Sungai Buloh, Malaysia, 47000
    • Pusat Perubatan UiTM Jalan Hospital
  • Sungai Petani, Malaysia, 8000
    • Hospital Sultan Abdul Halim
  • Taiping, Perak, Malaysia, 34000
    • Hospital Taiping
• United Kingdom
  • Antrim, United Kingdom, BT41 2RL
    • Antrim Area Hospital
  • Belfast, United Kingdom, BT16 1RH
    • Ulster Hospital
  • Belfast, United Kingdom, BT9 7AB
    • Belfast City Hospital
  • Birmingham, United Kingdom, B15 2TH
    • Queen Elizabeth Hospital
  • Blackburn, United Kingdom, BB2 1AX
    • Oakenhurst Medical Practice
  • Brighton, United Kingdom, BN2 5BE
    • Royal Sussex County Hospital
  • Bristol, United Kingdom, BS10 5NB
    • Southmead Hospital
  • Bury St Edmunds, United Kingdom, IP33 2QZ
    • West Suffolk Hospital
  • Canterbury, United Kingdom, CT1 3NG
    • Kent & Canterbury Hospital, Oncology Department, Canterbury
  • Cardiff, United Kingdom, CF14 4XW
    • University Hospital of Wales
  • Carshalton, United Kingdom, SM5 1AA
    • St Helier Hospital
  • Cheltenham, United Kingdom, GL53 7AN
    • Cheltenham General Hospital
  • Chippenham, United Kingdom, SN14 6GT
    • Hathaway Medical Centre
  • Coventry, United Kingdom, CV2 2DX
    • University Hospital Coventry
  • Dartford, United Kingdom, DA2 8DA
    • Darent Valley Hospital, Chemotherapy Unit
  • Derby, United Kingdom, DE22 3NE
    • Royal Derby Hospital
  • Dorchester, United Kingdom, DT1 2JY
    • Dorset County Hospital
  • Dundee, United Kingdom, DD1 9SY
    • Ninewells Hospital & Medical School
  • Edinburgh, United Kingdom, EH16 4SA
    • Royal Infirmary of Edinburgh
  • Exeter, United Kingdom, EX2 5DW
    • Royal Devon and Exeter Hospital
  • Glasgow, United Kingdom, G51 4TF
    • Queen Elizabeth University Hospital
  • Gloucester, United Kingdom, GL1 3NN
    • Gloucestershire Royal Hospital
  • Hull, United Kingdom, HU3 2JZ
    • Hull Royal Infirmary
  • Ipswich, United Kingdom, IP4 5PD
    • Ipswich Hospital
  • King's Lynn, United Kingdom, PE30 4ET
    • Queen Elizabeth Hospital
  • Leeds, United Kingdom, LS9 7TF
    • St James's University Hospital
  • Leicester, United Kingdom, LE5 4PW
    • University Hospitals of Leicester
  • Liverpool, United Kingdom, L9 7AL
    • Aintree University Hospital
  • London, United Kingdom, SE5 9RS
    • King's College Hospital
  • London, United Kingdom, Nw3 2QG
    • Royal Free Hospital
  • London, United Kingdom, N18 1QX
    • North Middlesex Hospital
  • London, United Kingdom, SW17 0QT
    • St George's Hospital
  • London, United Kingdom, W12 0HS
    • Hammersmith Hospital
  • London, United Kingdom, E1 1BB
    • The Royal London Hospital
  • Londonderry, United Kingdom, BT47 6SB
    • Altnagelvin Area Hospital
  • Newcastle, United Kingdom, NE7 7DN
    • Freeman Hospital
  • Newry, United Kingdom, BT35 8DR
    • Daisy Hill Hospital
  • Norwich, United Kingdom, NR4 7UY
    • Norfolk and Norwich University Hospital
  • Nottingham, United Kingdom, NG5 1PB
    • Nottingham City Hospital
  • Oxford, United Kingdom, OX3 7LE
    • Churchill Hospital
  • Oxford, United Kingdom, OX3 9RF
    • St Bartholomew's Medical Centre (OxFed)
  • Plymouth, United Kingdom, PL6 5FP
    • Derriford Hospital
  • Portsmouth, United Kingdom, PO6 3LY
    • Wessex Kidney Centre
  • Reading, United Kingdom, RG1 5AN
    • Royal Berkshire Hospital
  • Romford, United Kingdom, RM7 0AG
    • Queen's Hospital
  • Salford, United Kingdom, M6 8HD
    • Salford Royal Hospital
  • Sheffield, United Kingdom, S5 7AU
    • Northern General Hospital
  • Stevenage, United Kingdom, SG1 4AB
    • Lister Hospital
  • Stoke-on-Trent, United Kingdom, ST4 6QG
    • University Hospitals of North Midlands
  • Swindon, United Kingdom, SN3 6BB
    • Great Western Hospital
  • Telford, United Kingdom, TF1 6TF
    • Princess Royal Hospital
  • Truro, United Kingdom, TR1 3LQ
    • Royal Cornwall Hospital
  • Walsall, United Kingdom, WS2 9PS
    • Walsall Manor Hospital
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35805
      • Nephrology Consultants, LLC
  • Arizona
    • Mesa, Arizona, United States, 85210
      • Aventiv research, Inc
  • California
    • San Diego, California, United States, 92123
      • Southern California Permanente Medical Group
    • Sylmar, California, United States, 91342
      • University of California Los Angeles
    • Torrance, California, United States, 90502
      • University of California Los Angeles
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University School of Medicine
    • Thomaston, Connecticut, United States, 06787
      • Chase Medical Research, LLC
  • Florida
    • DeLand, Florida, United States, 32720
      • Midland Florida Clinical Reearch Center, LLC
    • Gainesville, Florida, United States, 32610
      • University of Florida
    • Jacksonville, Florida, United States, 32216
      • East Coast Institute for Research, LLC
    • Lake City, Florida, United States, 32055
      • East Coast Clinical Research, Inc
    • Miami, Florida, United States, 33126
      • Total Research Group, LLC
    • Port Charlotte, Florida, United States, 33952
      • Hanson Clinical Research Center, Inc.
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
    • Macon, Georgia, United States, 31210
      • The Jones Center for Diabetes and Endocrine Wellness
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Chicago, Illinois, United States, 60607
      • Cedar Crosse Research Center
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Kentucky
    • Covington, Kentucky, United States, 41011
      • Saint Elizabeth Healthcare
    • Lexington, Kentucky, United States, 40502
      • Lexington VA Health Care System - Troy Bowling Campus
  • Maryland
    • Baltimore, Maryland, United States, 21239
      • Medstar Health Research Institute
  • Massachusetts
    • West Springfield, Massachusetts, United States, 01089
      • Kidney Care and Transplant Services of New England, PC
  • Michigan
    • Roseville, Michigan, United States, 48066
      • Saint Clair Specialty Physicians
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Clinical Research Consultants, LLC
  • Nevada
    • North Las Vegas, Nevada, United States, 89086
      • VA Southern Nevada Healthcare System
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • Seacoast Kidney and Hypertension Specialists
  • New York
    • Brooklyn, New York, United States, 11203
      • SUNY Downstate Medical Center
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Mountain Kidney and Hypertension Associates, PA
    • Chapel Hill, North Carolina, United States, 27514
      • The University of North Carolina at Chapel Hill
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
    • Winston-Salem, North Carolina, United States, 27103
      • Brookview Hills Research Associates LLC
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Cleveland, Ohio, United States, 44106
      • University Hospitals of Cleveland
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19114
      • Thomas Jefferson University
  • South Carolina
    • Sumter, South Carolina, United States, 29150
      • Carolina Diabetes & Kidney Center
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Regional Health Clinical Research
  • Texas
    • Dallas, Texas, United States, 75231
      • Research Institute of Dallas
    • Dallas, Texas, United States, 75246
      • Renal Disease Research Institute
    • El Paso, Texas, United States, 79935
      • Academy Of Diabetes, Thyroid And Endocrine, PA
    • Houston, Texas, United States, 77099
      • Pioneer Research Solutions, Inc.
    • Lufkin, Texas, United States, 75904
      • P&I Clinical Research, LLC
    • Lufkin, Texas, United States, 75904
      • Texas Institute for Kidney and Endocrine Disorders
    • San Antonio, Texas, United States, 78229
      • University of Texas Health Science Center at San Antonio
    • San Antonio, Texas, United States, 78212
      • Clinical Advancement Center PLLC
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • University of Utah Health Sciences Center
  • Virginia
    • Salem, Virginia, United States, 24153
      • Salem VA Medical Center
  • Washington
    • Spokane, Washington, United States, 99204
      • Providence Medical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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;

Key Exclusion Criteria:

• 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
• Type 1 diabetes mellitus

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Empagliflozin; Taken daily with or without food
Placebo Comparator: 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.	Drug: Matching placebo; Taken daily with or without food

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Key Secondary Endpoint: Interventional Part - Time to First Hospitalization for Heart Failure ('as Adjudicated') or Cardiovascular Death ('as Adjudicated')	Time to first hospitalization for heart failure ('as adjudicated') or cardiovascular death ('as adjudicated') is reported as incidence rate of first hospitalization for heart failure or cardiovascular death. Incidence rate= (Number of patients who experienced the event of first hospitalization for heart failure 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.	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)	Time to occurrences of all-cause hospitalizations is reported as total number 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')	Time to death from any cause is reported as incidence rate of death from any cause. Incidence rate of death from any cause = (Number of patients who experienced the event of death from any cause) * 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.	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	Time to first occurrence of kidney disease progression (KDP) is reported as incidence rate of first occurrence of kidney disease progression. Incidence rate of first occurrence of kidney disease progression= (Number of patients who experienced the event of first occurrence of kidney disease progression) *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 of the interventional part, up to 1136 days.
Interventional Part: Time to Cardiovascular Death ('as Adjudicated')	Time to cardiovascular death ('as adjudicated') is reported as incidence rate of cardiovascular death. Incidence rate of cardiovascular death= (Number of patients who experienced the event of 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.	From the day of randomisation to the day of the final follow-up visit of the interventional part, up to 1140 days.
Interventional Part: Time to First Occurrence Cardiovascular Death ('as Adjudicated') or End Stage Kidney Disease (ESKD)	Time to first occurrence of cardiovascular death ('as adjudicated') or end stage kidney disease is reported as incidence rate of first occurrence of cardiovascular death or end stage kidney disease (ESKD). Incidence rate of first occurrence cardiovascular death or end stage kidney disease (ESKD)= (Number of patients who experienced the event of first occurrence of cardiovascular death or end stage kidney disease (ESKD)) *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. ESKD was defined as the initiation of maintenance dialysis or receipt of a kidney transplant.	From the day of randomization to the day of the final follow-up visit in the interventional part of the trial, up to 1140 days.
Overall Study: Time to First Occurrence of Kidney Disease Progression	The time to first occurrence of kidney disease progression in the interventional part of the trial and in the post-trial follow-up (non-interventional part) is reported as the incidence rate of first occurrence of kidney disease progression. Incidence rate of first occurrence of kidney disease progression= (Number of patients who experienced the event of first occurrence of kidney disease progression) *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 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.
Overall Study: Time to First Occurrence of Death From Any Cause or ESKD	Time to first occurrence of death from any cause or end stage kidney disease (ESKD) in the interventional part of the trial and in the post-trial follow-up (non-interventional part) is reported as incidence rate of first occurrence of death from any cause or ESKD. Incidence rate of first occurrence of death from any cause or end stage kidney disease (ESKD)= (Number of patients who experienced the event of first occurrence of death any cause or end stage kidney disease (ESKD)) *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. ESKD was defined as the initiation of maintenance dialysis or receipt of a kidney transplant.	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.
Overall Study: Time to First Occurrence of ESKD	Time to first occurrence of end stage kidney disease (ESKD) in the interventional part of the trial and in the post-trial follow-up (non-interventional part) is reported as incidence rate of first occurrence of ESKD. Incidence rate of first occurrence of end stage kidney disease (ESKD)= (Number of patients who experienced the event of first occurrence of ESKD) *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. ESKD was defined as the initiation of maintenance dialysis or receipt of a kidney transplant.	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.
Body Composition Measurement Sub-study: Mean Absolute Fluid Overload, Averaged Over Time	Mean absolute fluid overload averaged over time in the body composition measurement sub-study. Fluid overload or overhydration was measured using bioimpedance spectroscopy which derives the amount of water in liters (L) in the adipose tissue and lean mass tissues and computed as the difference between expected (based upon weight and body composition) versus measured extracellular water volume, with positive values representing excess fluid. A mixed model of repeated measures (MMRM) with terms for baseline, age, sex, screening diabetes status, local screening eGFR, local screening UACR, treatment, treatment-by-time interaction and baseline-by-time interaction was used for the analysis. The weighted mean of the values at 2 and 18 months.	MMRM included measurements at baseline, 2 months, and 18 months.
Magnetic Resonance Imaging Sub-study: Kidney Cortical T1 Mapping as Measured by Modified Look-Locker Inversion Recovery (MOLLI) at 18 Months	Kidney cortical T1 mapping using the modified Look-Locker inversion recovery (MOLLI) measured by magnetic resonance imaging (MRI) in the placebo and empagliflozin groups. A linear regression with terms for age, sex, screening diabetes status, local screening eGFR, local screening UACR was used in the analysis.	At 18 months.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim
• Collaborators: Eli Lilly and Company; University of Oxford

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2019
• Primary Completion (Actual): July 5, 2022
• Study Completion (Actual): July 2, 2024

Study Registration Dates

• First Submitted: July 10, 2018
• First Submitted That Met QC Criteria: July 10, 2018
• First Posted (Actual): July 20, 2018

Study Record Updates

• Last Update Posted (Actual): July 20, 2025
• Last Update Submitted That Met QC Criteria: June 30, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Sodium-Glucose Transporter 2 Inhibitors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hypoglycemic Agents; Empagliflozin
• Other Study ID Numbers: 1245-0137; 2017-002971-24 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing 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'.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No