AzTrials
AzTrials

Chronic Kidney DiseasePhase 3NCT03594110

EMPA-KIDNEY (The Study of Heart and Kidney Protection With Empagliflozin)

A Phase 3 study testing Empagliflozin in people with Chronic Kidney Disease, run by Boehringer Ingelheim at 240 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Kidney Disease
What is being tested?
Empagliflozin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
6,609 participants
Where
240 sitesin 8 countries
Study dates
31 Jan 2019to 2 Jul 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

240 sites in 8 countries.

240 sites in 8 countries

United Kingdom53 sites

  • Antrim Area Hospital

    Antrim, BT41 2RL

  • Ulster Hospital

    Belfast, BT16 1RH

  • Belfast City Hospital

    Belfast, BT9 7AB

  • Queen Elizabeth Hospital

    Birmingham, B15 2TH

  • Oakenhurst Medical Practice

    Blackburn, BB2 1AX

  • Royal Sussex County Hospital

    Brighton, BN2 5BE

  • Southmead Hospital

    Bristol, BS10 5NB

  • West Suffolk Hospital

    Bury St Edmunds, IP33 2QZ

  • Kent & Canterbury Hospital, Oncology Department, Canterbury

    Canterbury, CT1 3NG

  • University Hospital of Wales

    Cardiff, CF14 4XW

  • St Helier Hospital

    Carshalton, SM5 1AA

  • Cheltenham General Hospital

    Cheltenham, GL53 7AN

  • Hathaway Medical Centre

    Chippenham, SN14 6GT

  • University Hospital Coventry

    Coventry, CV2 2DX

  • Darent Valley Hospital, Chemotherapy Unit

    Dartford, DA2 8DA

  • Royal Derby Hospital

    Derby, DE22 3NE

  • Dorset County Hospital

    Dorchester, DT1 2JY

  • Ninewells Hospital & Medical School

    Dundee, DD1 9SY

  • Royal Infirmary of Edinburgh

    Edinburgh, EH16 4SA

  • Royal Devon and Exeter Hospital

    Exeter, EX2 5DW

  • Queen Elizabeth University Hospital

    Glasgow, G51 4TF

  • Gloucestershire Royal Hospital

    Gloucester, GL1 3NN

  • Hull Royal Infirmary

    Hull, HU3 2JZ

  • Ipswich Hospital

    Ipswich, IP4 5PD

  • Queen Elizabeth Hospital

    Kings Lynn, PE30 4ET

  • St James's University Hospital

    Leeds, LS9 7TF

  • University Hospitals of Leicester

    Leicester, LE5 4PW

  • Aintree University Hospital

    Liverpool, L9 7AL

  • The Royal London Hospital

    London, E1 1BB

  • North Middlesex Hospital

    London, N18 1QX

  • Royal Free Hospital

    London, NW3 2QG

  • King's College Hospital

    London, SE5 9RS

  • St George's Hospital

    London, SW17 0QT

  • Hammersmith Hospital

    London, W12 0HS

  • Altnagelvin Area Hospital

    Londonderry, BT47 6SB

  • Freeman Hospital

    Newcastle, NE7 7DN

  • Daisy Hill Hospital

    Newry, BT35 8DR

  • Norfolk and Norwich University Hospital

    Norwich, NR4 7UY

  • Nottingham City Hospital

    Nottingham, NG5 1PB

  • Churchill Hospital

    Oxford, OX3 7LE

  • St Bartholomew's Medical Centre (OxFed)

    Oxford, OX3 9RF

  • Derriford Hospital

    Plymouth, PL6 5FP

  • Wessex Kidney Centre

    Portsmouth, PO6 3LY

  • Royal Berkshire Hospital

    Reading, RG1 5AN

  • Queen's Hospital

    Romford, RM7 0AG

  • Salford Royal Hospital

    Salford, M6 8HD

  • Northern General Hospital

    Sheffield, S5 7AU

  • Lister Hospital

    Stevenage, SG1 4AB

  • University Hospitals of North Midlands

    Stoke-on-Trent, ST4 6QG

  • Great Western Hospital

    Swindon, SN3 6BB

  • Princess Royal Hospital

    Telford, TF1 6TF

  • Royal Cornwall Hospital

    Truro, TR1 3LQ

  • Walsall Manor Hospital

    Walsall, WS2 9PS

Other trials in United Kingdom

United States47 sites

  • Mountain Kidney and Hypertension Associates, PA

    Asheville, North Carolina, 28801

  • Emory University

    Atlanta, Georgia, 30322

  • Medstar Health Research Institute

    Baltimore, Maryland, 21239

  • SUNY Downstate Medical Center

    Brooklyn, New York, 11203

  • The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514

  • Cedar Crosse Research Center

    Chicago, Illinois, 60607

  • Northwestern University

    Chicago, Illinois, 60611

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Saint Elizabeth Healthcare

    Covington, Kentucky, 41011

  • Research Institute of Dallas

    Dallas, Texas, 75231

  • Renal Disease Research Institute

    Dallas, Texas, 75246

  • Midland Florida Clinical Reearch Center, LLC

    DeLand, Florida, 32720

  • Academy Of Diabetes, Thyroid And Endocrine, PA

    El Paso, Texas, 79935

  • University of Florida

    Gainesville, Florida, 32610

  • Pioneer Research Solutions, Inc.

    Houston, Texas, 77099

  • Nephrology Consultants, LLC

    Huntsville, Alabama, 35805

  • East Coast Institute for Research, LLC

    Jacksonville, Florida, 32216

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Clinical Research Consultants, LLC

    Kansas City, Missouri, 64111

  • East Coast Clinical Research, Inc

    Lake City, Florida, 32055

  • Lexington VA Health Care System - Troy Bowling Campus

    Lexington, Kentucky, 40502

  • P&I Clinical Research, LLC

    Lufkin, Texas, 75904

  • Texas Institute for Kidney and Endocrine Disorders

    Lufkin, Texas, 75904

  • The Jones Center for Diabetes and Endocrine Wellness

    Macon, Georgia, 31210

  • Aventiv Research, Inc

    Mesa, Arizona, 85210

  • Total Research Group, LLC

    Miami, Florida, 33126

  • Yale University School of Medicine

    New Haven, Connecticut, 06510

  • VA Southern Nevada Healthcare System

    North Las Vegas, Nevada, 89086

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19114

  • Hanson Clinical Research Center, Inc.

    Port Charlotte, Florida, 33952

  • Seacoast Kidney and Hypertension Specialists

    Portsmouth, New Hampshire, 03801

  • Regional Health Clinical Research

    Rapid City, South Dakota, 57701

  • Saint Clair Specialty Physicians

    Roseville, Michigan, 48066

  • Salem VA Medical Center

    Salem, Virginia, 24153

  • University of Utah Health Sciences Center

    Salt Lake City, Utah, 84108

  • Clinical Advancement Center PLLC

    San Antonio, Texas, 78212

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • Southern California Permanente Medical Group

    San Diego, California, 92123

  • Providence Medical Research Center

    Spokane, Washington, 99204

  • Carolina Diabetes & Kidney Center

    Sumter, South Carolina, 29150

  • University of California Los Angeles

    Sylmar, California, 91342

  • Chase Medical Research, LLC

    Thomaston, Connecticut, 06787

  • University of California Los Angeles

    Torrance, California, 90502

  • Kidney Care and Transplant Services of New England, PC

    West Springfield, Massachusetts, 01089

  • Brookview Hills Research Associates LLC

    Winston-Salem, North Carolina, 27103

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

Germany36 sites

  • Studienzentrum Aschaffenburg

    Aschaffenburg, 63739

  • Universitätsklinikum Augsburg

    Augsburg, 86156

  • Herz- und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen

    Bad Oeynhausen, 32545

  • Vivantes Netzwerk für Gesundheit GmbH

    Berlin, 12351

  • Ärztezentrum Helle Mitte

    Berlin, 12627

  • Klinikum Bielefeld gGmbH

    Bielefeld, 33604

  • Städtisches Klinikum Braunschweig gGmbH

    Braunschweig, 38126

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden, 01307

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225

  • Agaplesion Markus Krankenhaus

    Frankfurt, 60431

  • ClinPhenomics GmbH & Co KG, Frankfurt

    Frankfurt, 60594

  • Nierenzentrum Freiburg

    Freiburg im Breisgau, 79100

  • Nephrologisches Zentrum Göttingen

    Göttingen, 37075

  • Universitätsklinikum Halle/S.

    Halle, 06120

  • Zentrum für Nieren-, Hochdruck und Stoffwechselerkrankungen

    Hanover, 30453

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Dialysezentrum Heilbronn ÜBAG für Nephrologie und Dialyse

    Heilbronn, 74075

  • Nephrologisches Zentrum Hoyerswerda

    Hoyerswerda, 02977

  • Universitätsklinikum Jena

    Jena, 07747

  • Städt. Klinikum, Karlsruhe, Moltkestr.

    Karlsruhe, 76133

  • Klinikum St. Georg gGmbH

    Leipzig, 04129

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55131

  • Universitätsklinikum Mannheim GmbH

    Mannheim, 68167

  • Nephrologisches Zentrum Mettmann

    Mettmann, 40822

  • Klinikum der Universität München - Campus Innenstadt

    München, 80337

  • Dialysezentrum Neckarsulm

    Neckarsulm, 74172

  • KfH Kuratorium für Dialyse und Nierentransplantation e.V.

    Nuremberg, 90471

  • MVZ Diaverum Potsdam

    Potsdam, 14469

  • Universitätsklinikum Regensburg

    Regensburg, 93053

  • Robert-Bosch-Krankenhaus GmbH

    Stuttgart, 70376

  • Universitätsklinikum Ulm

    Ulm, 89081

  • Nephrologisches Zentrum Velbert

    Velbert, 42549

  • MVZ DaVita Viersen GmbH

    Viersen, 41751

  • Nephrologisches Zentrum Villingen-Schwenningen

    Villingen-Schwenningen, 78052

  • Gemeinschaftspraxis für Nephrologie und Rheumatologie

    Wiesbaden, 65191

  • Universitätsklinikum Würzburg AÖR

    Würzburg, 97080

Other trials in Germany

Japan25 sites

  • Aichi Medical University Hospital

    Aichi, 480-1195

  • Chubu Rosai Hospital

    Aichi, Nagoya, 455-8530

  • Fukui Prefectural Hospital

    Fukui, 910-8526

  • Fukuoka University Hospital

    Fukuoka, Fukuoka, 814-0180

  • Joumou Ohashi Clinic

    Gumma, Maebashi, 371-0046

  • Maebashi Hirosegawa Clinic

    Gunma, 371-0022

  • Ota Diabetes Clinic

    Gunma, 373-0861

  • University of Tsukuba Hospital

    Ibaraki, Tsukuba, 305-8576

  • Medical Corporation Seijinkai Ikeda Hospital

    Kagoshima, 893-0024

  • Tokai University Hospital

    Kanagawa, 259-1193

  • Koukan Clinic

    Kawasaki, 210-0852

  • Kobe University Hospital

    Kobe, 650-0017

  • Tohoku University Hospital

    Miyagi, Sendai, 980-8547

  • Nagoya University Hospital

    Nagoya, 466-8560

  • Kawasaki Medical School Hospital

    Okayama, Kurashiki, 701-0192

  • Okayama University Hospital

    Okayama, Okayama, 700-8558

  • AMC Nishi-umeda Clinic

    Osaka, 530-0001

  • Kansai Electric Power Hospital

    Osaka, 553-0003

  • Iwasaki Internal Medicine Clinic

    Osaka, 577-0802

  • Shiga University of Medical Science Hospital

    Shiga, Otsu, 520-2192

  • Tokyo-Eki Center-building Clinic

    Tokyo, 103-0027

  • Juntendo University Hospital

    Tokyo, Bunkyo-ku, 113-8431

  • The University of Tokyo Hospital

    Tokyo, Bunkyo-ku, 113-8655

  • Shin Clinic

    Tokyo, Ota-ku, 144-0051

  • Center Hospital of the National Center for Global Health and Medicine

    Tokyo, Shinjuku-ku, 162-8555

Other trials in Japan

Italy21 sites

  • Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo

    Alessandria, 15121

  • A.O. Policlinico Giovanni XXIII di Bari

    Bari, 70124

  • Policlinico S. Orsola Malpighi

    Bologna, 40138

  • ASST degli Spedali Civili di Brescia

    Brescia, 25123

  • A. O. Ospedale Civile di Vimercate e Circolo di Desio

    Desio, 20832

  • Osp. S. Giovanni di Dio

    Florence, 50143

  • Ospedale S. Cuore di Gesù

    Gallipoli, 73014

  • Azienda Ospedaliera San Martino

    Genova, 16132

  • Ospedale della Versilia

    LIDO DI Camaiore (LU), 55043

  • A.O.U.Policlinico G.Martino

    Messina, 98124

  • Milano Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico

    Milan, 20122

  • IRCCS San Raffaele

    Milan, 20132

  • AOU Università degli Studi della Campania Luigi Vanvitelli

    Naples, 80138

  • Azienda Ospedaliera Universitaria di Padova

    Padova, 35128

  • A.O. Univ. Policlinico "Paolo Giaccone"

    Palermo, 90127

  • Poli Univ A. Gemelli

    Roma, 00168

  • Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza

    Roma, 00189

  • IRCCS Ospedale "Casa Sollievo della Sofferenza"

    SAN Giovanni Rotondo (FG), 71013

  • Ospedale Ignazio Veris delli Ponti

    Scorrano (LE), 73020

  • Ospedale Martini

    Torino, 10141

  • A.O. Univ. Integrata di Verona

    Verona, 37126

Other trials in Italy

Malaysia21 sites

  • Hospital Sultanah Bahiyah

    Alor Setar, Kedah, 05460

  • Hospital Ampang

    Ampang, 68000

  • University Kebangsaan Malaysia

    Cheras, Kuala Lumpur, 56000

  • Hospital Pulau Pinang

    Georgetown, Pulau Pinang, 10450

  • Hospital Raja Permaisuri Bainun

    Ipoh, Perak, 30450

  • Hospital Sultanah Aminah

    Johor Bahru, 80100

  • Hospital Kajang

    Kajang, Selangor, 43000

  • Hospital Serdang

    Kajang, Selangor, 43000

  • Hospital Kuala Lumpur

    Kuala Lumpur, 50586

  • University of Malaya Medical Centre

    Kuala Lumpur, 59100

  • Hospital Selayang

    Kuala Selangor, 68100

  • Hospital Sultanah Nur Zahirah

    Kuala Terengganu, 20400

  • Hospital Tengku Ampuan Afzan

    Kuantan, 25100

  • Sarawak General Hospital

    Kuching, Sarawak, 93586

  • Hospital Kulim

    Kulim, Kedah, 9000

  • Hospital Melaka

    Malacca, 75400

  • Hospital Pakar Sultanah Fatimah

    Muar town, 84000

  • Hospital Tuanku Ja'afar

    Seremban, Negeri Sembilan, 70300

  • Pusat Perubatan UiTM Jalan Hospital

    Sungai Buloh, 47000

  • Hospital Sultan Abdul Halim

    Sungai Petani, 8000

  • Hospital Taiping

    Taiping, Perak, 34000

Other trials in Malaysia

Canada20 sites

  • LMC Clinical Research Inc. (Brampton)

    Brampton, Ontario, L6S 0C6

  • Cambridge Cardiac Care Centre

    Cambridge, Ontario, N1R 6V6

  • LMC Clinical Research Inc. (Thornhill)

    Concord, Ontario, L4K 4M2

  • LMC Endocrinology Centres (Etobicoke) Ltd.

    Etobicoke, Ontario, M9R 4E1

  • Kelowna General Hospital

    Kelowna, British Columbia, V1Y 1T2

  • London Health Science Centre, University Campus

    London, Ontario, N6A 4G5

  • Montreal Clinical Research Institute (IRCM)

    Montreal, Quebec, H2W 1R7

  • Hôpital du Sacré-Coeur de Montréal

    Montreal, Quebec, H4J 1C5

  • LMC Clinical Research Inc. (Ottawa)

    Nepean, Ontario, K2J 0V2

  • Lakeridge Health Oshawa

    Oshawa, Ontario, L1G 2B9

  • CHU de Quebec-Universite Laval Research Centre

    Québec, G1R 2J6

  • IUCPQ (Laval University)

    Québec, G1V 4G5

  • CHUS Hopital Fleurimont

    Sherbrooke, Quebec, J1H 5N4

  • Kidney Care Centre - Surrey

    Surrey, British Columbia, V3T 5H6

  • LMC Clinical Research Inc. (Bayview)

    Toronto, Ontario, M4G 3E8

  • Toronto General Hospital

    Toronto, Ontario, M5G 2N2

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

  • St. Paul's Hospital

    Vancouver, British Columbia, V6Z 1Y6

  • Fadia El Boreky Medicine Professional

    Waterloo, Ontario, N2J 1C4

  • Clinical Research Solutions Inc.

    Waterloo, Ontario, N2J 3Z4

Other trials in Canada

China17 sites

  • Beijing AnZhen Hospital

    Beijing, 100029

  • Cardiovascular Institute and Fu Wai Hospital

    Beijing, 100037

  • Xiangya Hospital, Central South University

    Changsha, 410008

  • Xinqiao Hospital

    Chongqing, 400037

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, 310000

  • Jinzhou Central Hospital

    Jinzhou, 121000

  • Jinling Hospital

    Nanjing, 210002

  • Shanghai Fifth People's Hospital affiliated to Fudan University

    Shanghai, 200240

  • Shenzhen People's Hospital

    Shenzhen, 518020

  • Huazhong University of Science and Technology Union Shenzhen Hospital

    Shenzhen, 518052

  • People's Hospital of Sichuan Province

    Sichuan, 610031

  • SuZhou Kowloon Hospital

    Suzhou, 215000

  • The Central Hospital of Wuhan

    Wuhan, 430014

  • Wuhan Fourth Hospital

    Wuhan, 430033

  • Henan Provincial People's Hospital

    Zhengzhou, 450003

  • Zhuzhou Central Hospital

    Zhuzhou, 412000

  • Zhuzhou Central Hospital

    Zhuzhou, 412007

Other trials in China

About this study

Official title: 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).

Being tested
Empagliflozin, Matching placebo
Medical subject headings
Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EmpagliflozinDrug

    Taken daily with or without food

  • Matching placeboDrug

    Taken daily with or without food

Study groups in NCT03594110
Study groupRoleWhat they receive
Empagliflozin 10 mgExperimentalPatients 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.
Receives: Drug: Empagliflozin
PlaceboPlacebo 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.
Receives: Drug: Matching placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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.

  2. 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.

    Measured: 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)

  1. 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.

    Measured: From the day of randomisation to the day of the final follow-up visit of the interventional part, up to 1140 days.

  2. 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).

    Measured: From the day of randomisation to the day of the final follow-up visit of the interventional part, up to 1140 days.

  3. 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.

    Measured: 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.

  4. 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).

    Measured: From the day of randomisation to the day of the final follow-up visit of the interventional part, up to 1136 days.

  5. 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.

    Measured: From the day of randomisation to the day of the final follow-up visit of the interventional part, up to 1140 days.

  6. 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.

    Measured: 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.

  7. 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.

    Measured: 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.

  8. 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.

    Measured: 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.

  9. 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.

    Measured: 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.

  10. 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.

    Measured: MMRM included measurements at baseline, 2 months, and 18 months.

  11. 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.

    Measured: At 18 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2018
  2. Study start31 Jan 2019
  3. Primary completion5 Jul 2022
  4. Study completion2 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
6,609 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03594110
Sponsor's protocol ID
1245-0137
Other IDs
2017-002971-24, 2017
Status last verified
Jun 2025
First submitted
10 Jul 2018
Last updated
20 Jul 2025
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Malijan GB, Herrington WG, Judge PK, Sardell RJ, Chapman D, Hill M, Moffat S, Zhu D, Cheung AK, Steubl D, Landray MJ, Wanner C, Baigent C, Haynes R, Ix JH, Staplin N, Shlipak MG; EMPA-KIDNEY Collaborative Group. Predictive Value of Urine Tubular Biomarkers on Kidney Outcomes: Observations from EMPA-KIDNEY. Clin J Am Soc Nephrol. 2026 Sep 3. doi: 10.2215/CJN.0000001203. Online ahead of print.

    PubMed 42690923

  • 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. 2026 Apr 1;37(4):764-776. doi: 10.1681/ASN.0000000928. Epub 2025 Nov 6.

    PubMed 41196655

  • 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 Dec;47(12):1091-1096. doi: 10.1016/j.clinthera.2025.09.005. Epub 2025 Oct 4.

    PubMed 41047325

  • 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.

    PubMed 40686671

  • 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.

    PubMed 40658498

  • 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.

    PubMed 40179340

  • 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.

    PubMed 39453837

  • 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.

    PubMed 38770818

  • Fletcher RA, Herrington WG, Agarwal R, Mayne KJ, Arnott C, Jardine MJ, Mahaffey KW, Perkovic V, Staplin N, Wheeler DC, Chertow GM, Heerspink HJL, Neuen BL. Effects of Sodium-Glucose Cotransporter 2 Inhibitors on Cause-Specific Cardiovascular Death in Patients with CKD: A Meta-Analysis of CKD Progression Trials. Clin J Am Soc Nephrol. 2024 Sep 1;19(9):1180-1182. doi: 10.2215/CJN.0000000000000470. Epub 2024 Apr 16.

    PubMed 38622766

  • 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.

    PubMed 38082486

  • 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.

    PubMed 38061372

  • 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.

    PubMed 38061371

  • 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.

    PubMed 36331190

  • 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.

    PubMed 35472672

  • 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.

    PubMed 34074889

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Empagliflozin in people with Chronic Kidney Disease, run by Boehringer Ingelheim at 240 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 240 sites in United Kingdom, United States, Germany, Japan, Italy and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Interventional Part: Time to First Occurrence of Kidney Disease Progression or Cardiovascular Death ('as Adjudicated') (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03594110, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.

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