Back to resultsEMPA-KIDNEY (The Study of Heart and Kidney Protection With Empagliflozin)
Primary Purpose
Chronic Kidney Disease
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Empagliflozin
Matching placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease
Eligibility Criteria
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 diseasee with an eGFR >60 mL/min/1.73m2 at Screening
- Receiving combined ACEi and ARBf 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 hypotensiond, 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
Sites / Locations
- Nephrology Consultants, LLC
- Aventiv Research Inc.
- Southern California Permanente Medical Group
- University of California Los Angeles
- University of California Los Angeles
- Yale University School of Medicine
- Chase Medical Research, LLC
- Midland Florida Clinical Reearch Center, LLC
- University of Florida
- East Coast Institute for Research, LLC
- East Coast Clinical Research, Inc
- Total Research Group, LLC
- Hanson Clinical Research Center, Inc.
- Emory University
- The Jones Center for Diabetes and Endocrine Wellness
- Cedar Crosse Research Center
- Northwestern University
- University of Kansas Medical Center
- Saint Elizabeth Healthcare
- Lexington VA Health Care System - Troy Bowling Campus
- Medstar Health Research Institute
- Kidney Care and Transplant Services of New England, PC
- Saint Clair Specialty Physicians
- Clinical Research Consultants, LLC
- VA Southern Nevada Healthcare System
- Seacoast Kidney and Hypertension Specialists
- SUNY Downstate Medical Center
- Mountain Kidney and Hypertension Associates, PA
- The University of North Carolina at Chapel Hill
- Brookview Hills Research Associates LLC
- Wake Forest University Health Sciences
- University Hospitals of Cleveland
- Cleveland Clinic
- Thomas Jefferson University
- Carolina Diabetes & Kidney Center
- Regional Health Clinical Research
- Research Institute of Dallas
- Renal Disease Research Institute
- Academy Of Diabetes, Thyroid And Endocrine, PA
- Pioneer Research Solutions, Inc.
- P&I Clinical Research, LLC
- Texas Institute for Kidney and Endocrine Disorders
- Clinical Advancement Center PLLC
- University of Texas Health Science Center at San Antonio
- University of Utah Health Sciences Center
- Salem VA Medical Center
- Providence Medical Research Center
- Kelowna General Hospital
- Kidney Care Centre - Surrey
- Vancouver General Hospital
- St. Paul's Hospital
- LMC Clinical Research Inc. (Brampton)
- Cambridge Cardiac Care Centre
- LMC Clinical Research Inc. (Thornhill)
- LMC Endocrinology Centres (Etobicoke) Ltd.
- London Health Science Centre, University Campus
- LMC Clinical Research Inc. (Ottawa)
- Lakeridge Health Oshawa
- LMC Clinical Research Inc. (Bayview)
- Toronto General Hospital
- Fadia El Boreky Medicine Professional
- Clinical Research Solutions Inc.
- Montreal Clinical Research Institute (IRCM)
- Hôpital du Sacré-Coeur de Montréal
- CHUS Fleurimont
- CHU de Quebec-Universite Laval Research Centre
- IUCPQ (Laval University)
- Beijing AnZhen Hospital
- Cardiovascular Institute and Fu Wai Hospital
- Xiangya Hospital, Central South University
- Xinqiao Hospital
- The Second Affiliated Hospital Zhejiang University School of Medicine
- Jinzhou Central Hospital
- Jinling Hospital
- Shanghai Fifth People's Hospital affiliated to Fudan University
- Shenzhen People's Hospital
- Huazhong University of Science and Technology Union Shenzhen Hospital
- People's Hospital of Sichuan Province
- SuZhou Kowloon Hospital
- The Central Hospital of Wuhan
- Wuhan Fourth Hospital
- Henan Provincial People's Hospital
- Zhuzhou Central Hospital
- Zhuzhou Central Hospital
- Studienzentrum Aschaffenburg
- Universitätsklinikum Augsburg
- Herz- und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen
- Vivantes Netzwerk für Gesundheit GmbH
- Ärztezentrum Helle Mitte
- Klinikum Bielefeld gGmbH
- Städtisches Klinikum Braunschweig gGmbH
- Universitätsklinikum Carl Gustav Carus Dresden
- Universitätsklinikum Düsseldorf
- Agaplesion Markus Krankenhaus
- ClinPhenomics GmbH & Co KG, Frankfurt
- Nierenzentrum Freiburg
- Nephrologisches Zentrum Göttingen
- Universitätsklinikum Halle/S.
- Zentrum für Nieren-, Hochdruck und Stoffwechselerkrankungen
- Medizinische Hochschule Hannover
- Dialysezentrum Heilbronn ÜBAG für Nephrologie und Dialyse
- Nephrologisches Zentrum Hoyerswerda
- Universitätsklinikum Jena
- Städt. Klinikum, Karlsruhe, Moltkestr.
- Klinikum St. Georg gGmbH
- Universitätsmedizin der Johannes Gutenberg-Universität Mainz
- Universitätsklinikum Mannheim GmbH
- Nephrologisches Zentrum Mettmann
- Klinikum der Universität München - Campus Innenstadt
- Dialysezentrum Neckarsulm
- KfH Kuratorium für Dialyse und Nierentransplantation e.V.
- MVZ Diaverum Potsdam
- Universitätsklinikum Regensburg
- Robert-Bosch-Krankenhaus GmbH
- Universitätsklinikum Ulm
- Nephrologisches Zentrum Velbert
- MVZ DaVita Viersen GmbH
- Nephrologisches Zentrum Villingen-Schwenningen
- Gemeinschaftspraxis für Nephrologie und Rheumatologie
- Universitätsklinikum Würzburg AÖR
- Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo
- A.O. Policlinico Giovanni XXIII di Bari
- Policlinico S. Orsola Malpighi
- ASST degli Spedali Civili di Brescia
- A. O. Ospedale Civile di Vimercate e Circolo di Desio
- Osp. S. Giovanni di Dio
- Ospedale S. Cuore di Gesù
- Azienda Ospedaliera San Martino
- Ospedale della Versilia
- A.O.U.Policlinico G.Martino
- Milano Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
- IRCCS San Raffaele
- AOU Università degli Studi della Campania Luigi Vanvitelli
- Azienda Ospedaliera Universitaria di Padova
- A.O. Univ. Policlinico "Paolo Giaccone"
- Poli Univ A. Gemelli
- Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
- IRCCS Ospedale "Casa Sollievo della Sofferenza"
- Ospedale Ignazio Veris delli Ponti
- Ospedale Martini
- A.O. Univ. Integrata di Verona
- Chubu Rosai Hospital
- Aichi Medical University Hospital
- Fukui Prefectural Hospital
- Fukuoka University Hospital
- Joumou Ohashi Clinic
- Maebashi Hirosegawa Clinic
- Ota Diabetes Clinic
- University of Tsukuba Hospital
- Medical Corporation Seijinkai Ikeda Hospital
- Tokai University Hospital
- Koukan Clinic
- Kobe University Hospital
- Tohoku University Hospital
- Nagoya University Hospital
- Kawasaki Medical School Hospital
- Okayama University Hospital
- AMC Nishi-umeda Clinic
- Kansai Electric Power Hospital
- Iwasaki Internal Medicine Clinic
- Shiga University of Medical Science Hospital
- Juntendo University Hospital
- The University of Tokyo Hospital
- Shin Clinic
- Center Hospital of the National Center for Global Health and Medicine
- Tokyo-Eki Center-building Clinic
- Hospital Sultanah Bahiyah
- Hospital Ampang
- University Kebangsaan Malaysia
- Hospital Pulau Pinang
- Hospital Raja Permaisuri Bainun
- Hospital Sultanah Aminah
- Hospital Kajang
- Hospital Serdang
- Hospital Kuala Lumpur
- University of Malaya Medical Centre
- Hospital Sultanah Nur Zahirah
- Hospital Tengku Ampuan Afzan
- Sarawak General Hospital
- Hospital Kulim
- Hospital Melaka
- Hospital Pakar Sultanah Fatimah
- Hospital Selayang
- Hospital Tuanku Ja'afar
- Pusat Perubatan UiTM Jalan Hospital
- Hospital Sultan Abdul Halim
- Hospital Taiping
- Antrim Area Hospital
- Ulster Hospital
- Belfast City Hospital
- Queen Elizabeth Hospital
- Oakenhurst Medical Practice
- Royal Sussex County Hospital
- Southmead Hospital
- West Suffolk Hospital
- Kent & Canterbury Hospital, Oncology Department, Canterbury
- University Hospital of Wales
- St Helier Hospital
- Cheltenham General Hospital
- Hathaway Medical Centre
- University Hospital Coventry
- Darent Valley Hospital, Chemotherapy Unit
- Royal Derby Hospital
- Dorset County Hospital
- Ninewells Hospital & Medical School
- Royal Infirmary of Edinburgh
- Royal Devon and Exeter Hospital
- Queen Elizabeth University Hospital
- Gloucestershire Royal Hospital
- Hull Royal Infirmary
- Ipswich Hospital
- Queen Elizabeth Hospital
- St James's University Hospital
- University Hospitals of Leicester
- Aintree University Hospital
- Altnagelvin Area Hospital
- The Royal London Hospital
- North Middlesex Hospital
- Royal Free Hospital
- King's College Hospital
- St George's Hospital
- Hammersmith Hospital
- Freeman Hospital
- Daisy Hill Hospital
- Norfolk and Norwich University Hospital
- Nottingham City Hospital
- Churchill Hospital
- St Bartholomew's Medical Centre (OxFed)
- Derriford Hospital
- Wessex Kidney Centre
- Royal Berkshire Hospital
- Queen's Hospital
- Salford Royal Hospital
- Northern General Hospital
- Lister Hospital
- University Hospitals of North Midlands
- Great Western Hospital
- Princess Royal Hospital
- Royal Cornwall Hospital
- Walsall Manor Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Empagliflozin 10 mg
Placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Interventional Part: Time to First Occurrence of Kidney Disease Progression or Cardiovascular Death ('as Adjudicated')
Incidence rate of first occurrence of kidney disease progression (KDP) or adjudicated cardiovascular death is reported in the Outcome Measure Data Table. Metrics such as the median time-to-event (TTE) was not estimable due to insufficient events being experienced.
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.
Secondary Outcome Measures
Key Secondary Endpoint: Interventional Part - Time to First Hospitalization for Heart Failure ('as Adjudicated') or Cardiovascular Death ('as Adjudicated')
Incidence rate of first hospitalization for heart failure or cardiovascular death is reported in the Outcome Measure Data Table because metrics such as the median time-to-event (TTE) not estimable due to insufficient events being experienced.
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.
Key Secondary Endpoint: Interventional Part - Time to Occurrences of All-cause Hospitalizations (First and Recurrent Combined)
Total number of all-cause hospitalizations (first and recurrent combined) is reported in the Outcome Measure Data Table. Conventional time-to-event (TTE) metrics such as the median not calculable for a recurrent TTE analysis.
Key Secondary Endpoint: Interventional Part - Time to Death From Any Cause ('as Adjudicated')
Incidence rate of death from any cause is reported in the Outcome Measure Data Table. Metrics such as the median time-to-event (TTE) not estimable due to insufficient events being experienced.
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.
Interventional Part: Time to First Occurrence of Kidney Disease Progression
Incidence rate of first occurrence of kidney disease progression is reported in the Outcome Measure Data Table. Metrics such as the median time-to-event (TTE) not estimable due to insufficient events being experienced.
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).
Interventional Part: Time to Cardiovascular Death ('as Adjudicated')
Incidence rate of first occurrence of kidney disease progression is reported in the Outcome Measure Data Table. Metrics such as the median time-to-event (TTE) not estimable due to insufficient events being experienced.
Incidence rate of cardiovascular death is reported in the Outcome Measure Data Table. Metrics such as the median time-to-event (TTE) not estimable due to too few events being experienced.
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.
Interventional Part: Time to First Occurrence Cardiovascular Death ('as Adjudicated') or End Stage Kidney Disease (ESKD)
Incidence rate of first occurrence of cardiovascular death or end stage kidney disease (ESKD) is reported in the Outcome Measure Data Table. Metrics such as the median time-to-event (TTE) not estimable due to insufficient events being experienced.
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.
Full Information
NCT ID
NCT03594110
First Posted
July 10, 2018
Last Updated
August 2, 2023
Sponsor
Boehringer Ingelheim
Collaborators
Medical Research Council Population Health Research Unit, CTSU, University of Oxford (academic lead), Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT03594110
Brief Title
EMPA-KIDNEY (The Study of Heart and Kidney Protection With Empagliflozin)
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 31, 2019 (Actual)
Primary Completion Date
July 5, 2022 (Actual)
Study Completion Date
January 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
Collaborators
Medical Research Council Population Health Research Unit, CTSU, University of Oxford (academic lead), Eli Lilly and Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
6609 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Empagliflozin 10 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Empagliflozin
Intervention Description
Taken daily with or without food
Intervention Type
Drug
Intervention Name(s)
Matching placebo
Intervention Description
Taken daily with or without food
Primary Outcome Measure Information:
Title
Interventional Part: Time to First Occurrence of Kidney Disease Progression or Cardiovascular Death ('as Adjudicated')
Description
Incidence rate of first occurrence of kidney disease progression (KDP) or adjudicated cardiovascular death is reported in the Outcome Measure Data Table. Metrics such as the median time-to-event (TTE) was not estimable due to insufficient events being experienced.
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.
Time Frame
Follow-up period: From the day of randomisation to the day of the final follow-up visit, up to 1136 days.
Secondary Outcome Measure Information:
Title
Key Secondary Endpoint: Interventional Part - Time to First Hospitalization for Heart Failure ('as Adjudicated') or Cardiovascular Death ('as Adjudicated')
Description
Incidence rate of first hospitalization for heart failure or cardiovascular death is reported in the Outcome Measure Data Table because metrics such as the median time-to-event (TTE) not estimable due to insufficient events being experienced.
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.
Time Frame
Follow-up period: From the day of randomisation to the day of the final follow-up visit, up to 1140 days.
Title
Key Secondary Endpoint: Interventional Part - Time to Occurrences of All-cause Hospitalizations (First and Recurrent Combined)
Description
Total number of all-cause hospitalizations (first and recurrent combined) is reported in the Outcome Measure Data Table. Conventional time-to-event (TTE) metrics such as the median not calculable for a recurrent TTE analysis.
Time Frame
Follow-up period: From the day of randomisation to the day of the final follow-up visit, up to 1140 days.
Title
Key Secondary Endpoint: Interventional Part - Time to Death From Any Cause ('as Adjudicated')
Description
Incidence rate of death from any cause is reported in the Outcome Measure Data Table. Metrics such as the median time-to-event (TTE) not estimable due to insufficient events being experienced.
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.
Time Frame
Follow-up period: From the day of randomisation to the day of the final follow-up visit, up to 1140 days.
Title
Interventional Part: Time to First Occurrence of Kidney Disease Progression
Description
Incidence rate of first occurrence of kidney disease progression is reported in the Outcome Measure Data Table. Metrics such as the median time-to-event (TTE) not estimable due to insufficient events being experienced.
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).
Time Frame
Follow-up period: From the day of randomisation to the day of the final follow-up visit, up to 1136 days.
Title
Interventional Part: Time to Cardiovascular Death ('as Adjudicated')
Description
Incidence rate of first occurrence of kidney disease progression is reported in the Outcome Measure Data Table. Metrics such as the median time-to-event (TTE) not estimable due to insufficient events being experienced.
Incidence rate of cardiovascular death is reported in the Outcome Measure Data Table. Metrics such as the median time-to-event (TTE) not estimable due to too few events being experienced.
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.
Time Frame
Follow-up period: From the day of randomisation to the day of the final follow-up visit, up to 1140 days.
Title
Interventional Part: Time to First Occurrence Cardiovascular Death ('as Adjudicated') or End Stage Kidney Disease (ESKD)
Description
Incidence rate of first occurrence of cardiovascular death or end stage kidney disease (ESKD) is reported in the Outcome Measure Data Table. Metrics such as the median time-to-event (TTE) not estimable due to insufficient events being experienced.
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.
Time Frame
Follow-up period: From the day of randomisation to the day of the final follow-up visit, up to 1140 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 diseasee with an eGFR >60 mL/min/1.73m2 at Screening
Receiving combined ACEi and ARBf 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 hypotensiond, 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
Facility Information:
Facility Name
Nephrology Consultants, LLC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35805
Country
United States
Facility Name
Aventiv Research Inc.
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210
Country
United States
Facility Name
Southern California Permanente Medical Group
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
University of California Los Angeles
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
Facility Name
University of California Los Angeles
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Chase Medical Research, LLC
City
Thomaston
State/Province
Connecticut
ZIP/Postal Code
06787
Country
United States
Facility Name
Midland Florida Clinical Reearch Center, LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
East Coast Institute for Research, LLC
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
East Coast Clinical Research, Inc
City
Lake City
State/Province
Florida
ZIP/Postal Code
32055
Country
United States
Facility Name
Total Research Group, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Hanson Clinical Research Center, Inc.
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
The Jones Center for Diabetes and Endocrine Wellness
City
Macon
State/Province
Georgia
ZIP/Postal Code
31210
Country
United States
Facility Name
Cedar Crosse Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Saint Elizabeth Healthcare
City
Covington
State/Province
Kentucky
ZIP/Postal Code
41011
Country
United States
Facility Name
Lexington VA Health Care System - Troy Bowling Campus
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40502
Country
United States
Facility Name
Medstar Health Research Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21239
Country
United States
Facility Name
Kidney Care and Transplant Services of New England, PC
City
West Springfield
State/Province
Massachusetts
ZIP/Postal Code
01089
Country
United States
Facility Name
Saint Clair Specialty Physicians
City
Roseville
State/Province
Michigan
ZIP/Postal Code
48066
Country
United States
Facility Name
Clinical Research Consultants, LLC
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
VA Southern Nevada Healthcare System
City
North Las Vegas
State/Province
Nevada
ZIP/Postal Code
89086
Country
United States
Facility Name
Seacoast Kidney and Hypertension Specialists
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
SUNY Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Mountain Kidney and Hypertension Associates, PA
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
The University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Brookview Hills Research Associates LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
Carolina Diabetes & Kidney Center
City
Sumter
State/Province
South Carolina
ZIP/Postal Code
29150
Country
United States
Facility Name
Regional Health Clinical Research
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Research Institute of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Renal Disease Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Academy Of Diabetes, Thyroid And Endocrine, PA
City
El Paso
State/Province
Texas
ZIP/Postal Code
79935
Country
United States
Facility Name
Pioneer Research Solutions, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Facility Name
P&I Clinical Research, LLC
City
Lufkin
State/Province
Texas
ZIP/Postal Code
75904
Country
United States
Facility Name
Texas Institute for Kidney and Endocrine Disorders
City
Lufkin
State/Province
Texas
ZIP/Postal Code
75904
Country
United States
Facility Name
Clinical Advancement Center PLLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78212
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Utah Health Sciences Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
Salem VA Medical Center
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
Facility Name
Providence Medical Research Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Kelowna General Hospital
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 1T2
Country
Canada
Facility Name
Kidney Care Centre - Surrey
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3T 5H6
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
LMC Clinical Research Inc. (Brampton)
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6S 0C6
Country
Canada
Facility Name
Cambridge Cardiac Care Centre
City
Cambridge
State/Province
Ontario
ZIP/Postal Code
N1R 6V6
Country
Canada
Facility Name
LMC Clinical Research Inc. (Thornhill)
City
Concord
State/Province
Ontario
ZIP/Postal Code
L4K 4M2
Country
Canada
Facility Name
LMC Endocrinology Centres (Etobicoke) Ltd.
City
Etobicoke
State/Province
Ontario
ZIP/Postal Code
M9R 4E1
Country
Canada
Facility Name
London Health Science Centre, University Campus
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
LMC Clinical Research Inc. (Ottawa)
City
Nepean
State/Province
Ontario
ZIP/Postal Code
K2J 0V2
Country
Canada
Facility Name
Lakeridge Health Oshawa
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
LMC Clinical Research Inc. (Bayview)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 3E8
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Facility Name
Fadia El Boreky Medicine Professional
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Clinical Research Solutions Inc.
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 3Z4
Country
Canada
Facility Name
Montreal Clinical Research Institute (IRCM)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1R7
Country
Canada
Facility Name
Hôpital du Sacré-Coeur de Montréal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
CHUS Fleurimont
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
CHU de Quebec-Universite Laval Research Centre
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
IUCPQ (Laval University)
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Beijing AnZhen Hospital
City
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Cardiovascular Institute and Fu Wai Hospital
City
Beijing
ZIP/Postal Code
100037
Country
China
Facility Name
Xiangya Hospital, Central South University
City
Changsha
ZIP/Postal Code
410008
Country
China
Facility Name
Xinqiao Hospital
City
Chongqing
ZIP/Postal Code
400037
Country
China
Facility Name
The Second Affiliated Hospital Zhejiang University School of Medicine
City
Hangzhou
ZIP/Postal Code
310000
Country
China
Facility Name
Jinzhou Central Hospital
City
Jinzhou
ZIP/Postal Code
121000
Country
China
Facility Name
Jinling Hospital
City
Nanjing
ZIP/Postal Code
210002
Country
China
Facility Name
Shanghai Fifth People's Hospital affiliated to Fudan University
City
Shanghai
ZIP/Postal Code
200240
Country
China
Facility Name
Shenzhen People's Hospital
City
Shenzhen
ZIP/Postal Code
518020
Country
China
Facility Name
Huazhong University of Science and Technology Union Shenzhen Hospital
City
Shenzhen
ZIP/Postal Code
518052
Country
China
Facility Name
People's Hospital of Sichuan Province
City
Sichuan
ZIP/Postal Code
610031
Country
China
Facility Name
SuZhou Kowloon Hospital
City
Suzhou
ZIP/Postal Code
215000
Country
China
Facility Name
The Central Hospital of Wuhan
City
Wuhan
ZIP/Postal Code
430014
Country
China
Facility Name
Wuhan Fourth Hospital
City
Wuhan
ZIP/Postal Code
430033
Country
China
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
ZIP/Postal Code
450003
Country
China
Facility Name
Zhuzhou Central Hospital
City
Zhuzhou
ZIP/Postal Code
412000
Country
China
Facility Name
Zhuzhou Central Hospital
City
Zhuzhou
ZIP/Postal Code
412007
Country
China
Facility Name
Studienzentrum Aschaffenburg
City
Aschaffenburg
ZIP/Postal Code
63739
Country
Germany
Facility Name
Universitätsklinikum Augsburg
City
Augsburg
ZIP/Postal Code
86156
Country
Germany
Facility Name
Herz- und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen
City
Bad Oeynhausen
ZIP/Postal Code
32545
Country
Germany
Facility Name
Vivantes Netzwerk für Gesundheit GmbH
City
Berlin
ZIP/Postal Code
12351
Country
Germany
Facility Name
Ärztezentrum Helle Mitte
City
Berlin
ZIP/Postal Code
12627
Country
Germany
Facility Name
Klinikum Bielefeld gGmbH
City
Bielefeld
ZIP/Postal Code
33604
Country
Germany
Facility Name
Städtisches Klinikum Braunschweig gGmbH
City
Braunschweig
ZIP/Postal Code
38126
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsklinikum Düsseldorf
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Agaplesion Markus Krankenhaus
City
Frankfurt
ZIP/Postal Code
60431
Country
Germany
Facility Name
ClinPhenomics GmbH & Co KG, Frankfurt
City
Frankfurt
ZIP/Postal Code
60594
Country
Germany
Facility Name
Nierenzentrum Freiburg
City
Freiburg
ZIP/Postal Code
79100
Country
Germany
Facility Name
Nephrologisches Zentrum Göttingen
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Universitätsklinikum Halle/S.
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Zentrum für Nieren-, Hochdruck und Stoffwechselerkrankungen
City
Hannover
ZIP/Postal Code
30453
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Dialysezentrum Heilbronn ÜBAG für Nephrologie und Dialyse
City
Heilbronn
ZIP/Postal Code
74075
Country
Germany
Facility Name
Nephrologisches Zentrum Hoyerswerda
City
Hoyerswerda
ZIP/Postal Code
02977
Country
Germany
Facility Name
Universitätsklinikum Jena
City
Jena
ZIP/Postal Code
07747
Country
Germany
Facility Name
Städt. Klinikum, Karlsruhe, Moltkestr.
City
Karlsruhe
ZIP/Postal Code
76133
Country
Germany
Facility Name
Klinikum St. Georg gGmbH
City
Leipzig
ZIP/Postal Code
04129
Country
Germany
Facility Name
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Universitätsklinikum Mannheim GmbH
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Nephrologisches Zentrum Mettmann
City
Mettmann
ZIP/Postal Code
40822
Country
Germany
Facility Name
Klinikum der Universität München - Campus Innenstadt
City
München
ZIP/Postal Code
80337
Country
Germany
Facility Name
Dialysezentrum Neckarsulm
City
Neckarsulm
ZIP/Postal Code
74172
Country
Germany
Facility Name
KfH Kuratorium für Dialyse und Nierentransplantation e.V.
City
Nürnberg
ZIP/Postal Code
90471
Country
Germany
Facility Name
MVZ Diaverum Potsdam
City
Potsdam
ZIP/Postal Code
14469
Country
Germany
Facility Name
Universitätsklinikum Regensburg
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Robert-Bosch-Krankenhaus GmbH
City
Stuttgart
ZIP/Postal Code
70376
Country
Germany
Facility Name
Universitätsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Nephrologisches Zentrum Velbert
City
Velbert
ZIP/Postal Code
42549
Country
Germany
Facility Name
MVZ DaVita Viersen GmbH
City
Viersen
ZIP/Postal Code
41751
Country
Germany
Facility Name
Nephrologisches Zentrum Villingen-Schwenningen
City
Villingen-Schwenningen
ZIP/Postal Code
78052
Country
Germany
Facility Name
Gemeinschaftspraxis für Nephrologie und Rheumatologie
City
Wiesbaden
ZIP/Postal Code
65191
Country
Germany
Facility Name
Universitätsklinikum Würzburg AÖR
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo
City
Alessandria
ZIP/Postal Code
15121
Country
Italy
Facility Name
A.O. Policlinico Giovanni XXIII di Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Policlinico S. Orsola Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
ASST degli Spedali Civili di Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
A. O. Ospedale Civile di Vimercate e Circolo di Desio
City
Desio
ZIP/Postal Code
20832
Country
Italy
Facility Name
Osp. S. Giovanni di Dio
City
Firenze
ZIP/Postal Code
50143
Country
Italy
Facility Name
Ospedale S. Cuore di Gesù
City
Gallipoli
ZIP/Postal Code
73014
Country
Italy
Facility Name
Azienda Ospedaliera San Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Ospedale della Versilia
City
LIDO DI Camaiore (LU)
ZIP/Postal Code
55043
Country
Italy
Facility Name
A.O.U.Policlinico G.Martino
City
Messina
ZIP/Postal Code
98124
Country
Italy
Facility Name
Milano Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
IRCCS San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
AOU Università degli Studi della Campania Luigi Vanvitelli
City
Napoli
ZIP/Postal Code
80138
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
A.O. Univ. Policlinico "Paolo Giaccone"
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Poli Univ A. Gemelli
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
City
Roma
ZIP/Postal Code
00189
Country
Italy
Facility Name
IRCCS Ospedale "Casa Sollievo della Sofferenza"
City
SAN Giovanni Rotondo (FG)
ZIP/Postal Code
71013
Country
Italy
Facility Name
Ospedale Ignazio Veris delli Ponti
City
Scorrano (LE)
ZIP/Postal Code
73020
Country
Italy
Facility Name
Ospedale Martini
City
Torino
ZIP/Postal Code
10141
Country
Italy
Facility Name
A.O. Univ. Integrata di Verona
City
Verona
ZIP/Postal Code
37126
Country
Italy
Facility Name
Chubu Rosai Hospital
City
Aichi, Nagoya
ZIP/Postal Code
455-8530
Country
Japan
Facility Name
Aichi Medical University Hospital
City
Aichi
ZIP/Postal Code
480-1195
Country
Japan
Facility Name
Fukui Prefectural Hospital
City
Fukui City
ZIP/Postal Code
910-8526
Country
Japan
Facility Name
Fukuoka University Hospital
City
Fukuoka, Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Facility Name
Joumou Ohashi Clinic
City
Gumma, Maebashi
ZIP/Postal Code
371-0046
Country
Japan
Facility Name
Maebashi Hirosegawa Clinic
City
Gunma
ZIP/Postal Code
371-0022
Country
Japan
Facility Name
Ota Diabetes Clinic
City
Gunma
ZIP/Postal Code
373-0861
Country
Japan
Facility Name
University of Tsukuba Hospital
City
Ibaraki, Tsukuba
ZIP/Postal Code
305-8576
Country
Japan
Facility Name
Medical Corporation Seijinkai Ikeda Hospital
City
Kagoshima
ZIP/Postal Code
893-0024
Country
Japan
Facility Name
Tokai University Hospital
City
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Facility Name
Koukan Clinic
City
Kawasaki
ZIP/Postal Code
210-0852
Country
Japan
Facility Name
Kobe University Hospital
City
Kobe
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
Tohoku University Hospital
City
Miyagi, Sendai
ZIP/Postal Code
980-8547
Country
Japan
Facility Name
Nagoya University Hospital
City
Nagoya
ZIP/Postal Code
466-8560
Country
Japan
Facility Name
Kawasaki Medical School Hospital
City
Okayama, Kurashiki
ZIP/Postal Code
701-0192
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama, Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
AMC Nishi-umeda Clinic
City
Osaka
ZIP/Postal Code
530-0001
Country
Japan
Facility Name
Kansai Electric Power Hospital
City
Osaka
ZIP/Postal Code
553-0003
Country
Japan
Facility Name
Iwasaki Internal Medicine Clinic
City
Osaka
ZIP/Postal Code
577-0802
Country
Japan
Facility Name
Shiga University of Medical Science Hospital
City
Shiga, Otsu
ZIP/Postal Code
520-2192
Country
Japan
Facility Name
Juntendo University Hospital
City
Tokyo, Bunkyo-ku
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
The University of Tokyo Hospital
City
Tokyo, Bunkyo-ku
ZIP/Postal Code
113-8655
Country
Japan
Facility Name
Shin Clinic
City
Tokyo, Ota-ku
ZIP/Postal Code
144-0051
Country
Japan
Facility Name
Center Hospital of the National Center for Global Health and Medicine
City
Tokyo, Shinjuku-ku
ZIP/Postal Code
162-8555
Country
Japan
Facility Name
Tokyo-Eki Center-building Clinic
City
Tokyo
ZIP/Postal Code
103-0027
Country
Japan
Facility Name
Hospital Sultanah Bahiyah
City
Alor Setar, Kedah
ZIP/Postal Code
05460
Country
Malaysia
Facility Name
Hospital Ampang
City
Ampang
ZIP/Postal Code
68000
Country
Malaysia
Facility Name
University Kebangsaan Malaysia
City
Cheras, Kuala Lumpur
ZIP/Postal Code
56000
Country
Malaysia
Facility Name
Hospital Pulau Pinang
City
Georgetown, Pulau Pinang
ZIP/Postal Code
10450
Country
Malaysia
Facility Name
Hospital Raja Permaisuri Bainun
City
Ipoh, Perak
ZIP/Postal Code
30450
Country
Malaysia
Facility Name
Hospital Sultanah Aminah
City
Johor Bahru
ZIP/Postal Code
80100
Country
Malaysia
Facility Name
Hospital Kajang
City
Kajang, Selangor
ZIP/Postal Code
43000
Country
Malaysia
Facility Name
Hospital Serdang
City
Kajang, Selangor
ZIP/Postal Code
43000
Country
Malaysia
Facility Name
Hospital Kuala Lumpur
City
Kuala Lumpur
ZIP/Postal Code
50586
Country
Malaysia
Facility Name
University of Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Hospital Sultanah Nur Zahirah
City
Kuala Trengganu
ZIP/Postal Code
20400
Country
Malaysia
Facility Name
Hospital Tengku Ampuan Afzan
City
Kuantan
ZIP/Postal Code
25100
Country
Malaysia
Facility Name
Sarawak General Hospital
City
Kuching, Sarawak
ZIP/Postal Code
93586
Country
Malaysia
Facility Name
Hospital Kulim
City
Kulim, Kedah
ZIP/Postal Code
9000
Country
Malaysia
Facility Name
Hospital Melaka
City
Melaka
ZIP/Postal Code
75400
Country
Malaysia
Facility Name
Hospital Pakar Sultanah Fatimah
City
Muar
ZIP/Postal Code
84000
Country
Malaysia
Facility Name
Hospital Selayang
City
Selangor
ZIP/Postal Code
68100
Country
Malaysia
Facility Name
Hospital Tuanku Ja'afar
City
Seremban, Negeri Sembilan
ZIP/Postal Code
70300
Country
Malaysia
Facility Name
Pusat Perubatan UiTM Jalan Hospital
City
Sungai Buloh
ZIP/Postal Code
47000
Country
Malaysia
Facility Name
Hospital Sultan Abdul Halim
City
Sungai Petani
ZIP/Postal Code
8000
Country
Malaysia
Facility Name
Hospital Taiping
City
Taiping, Perak
ZIP/Postal Code
34000
Country
Malaysia
Facility Name
Antrim Area Hospital
City
Antrim
ZIP/Postal Code
BT41 2RL
Country
United Kingdom
Facility Name
Ulster Hospital
City
Belfast
ZIP/Postal Code
BT16 1RH
Country
United Kingdom
Facility Name
Belfast City Hospital
City
Belfast
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Oakenhurst Medical Practice
City
Blackburn
ZIP/Postal Code
BB2 1AX
Country
United Kingdom
Facility Name
Royal Sussex County Hospital
City
Brighton
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Southmead Hospital
City
Bristol
ZIP/Postal Code
BS10 5NB
Country
United Kingdom
Facility Name
West Suffolk Hospital
City
Bury St Edmunds
ZIP/Postal Code
IP33 2QZ
Country
United Kingdom
Facility Name
Kent & Canterbury Hospital, Oncology Department, Canterbury
City
Canterbury
ZIP/Postal Code
CT1 3NG
Country
United Kingdom
Facility Name
University Hospital of Wales
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
St Helier Hospital
City
Carshalton
ZIP/Postal Code
SM5 1AA
Country
United Kingdom
Facility Name
Cheltenham General Hospital
City
Cheltenham
ZIP/Postal Code
GL53 7AN
Country
United Kingdom
Facility Name
Hathaway Medical Centre
City
Chippenham
ZIP/Postal Code
SN14 6GT
Country
United Kingdom
Facility Name
University Hospital Coventry
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Darent Valley Hospital, Chemotherapy Unit
City
Dartford
ZIP/Postal Code
DA2 8DA
Country
United Kingdom
Facility Name
Royal Derby Hospital
City
Derby
ZIP/Postal Code
DE22 3NE
Country
United Kingdom
Facility Name
Dorset County Hospital
City
Dorchester
ZIP/Postal Code
DT1 2JY
Country
United Kingdom
Facility Name
Ninewells Hospital & Medical School
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Royal Infirmary of Edinburgh
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Facility Name
Royal Devon and Exeter Hospital
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Queen Elizabeth University Hospital
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
Gloucestershire Royal Hospital
City
Gloucester
ZIP/Postal Code
GL1 3NN
Country
United Kingdom
Facility Name
Hull Royal Infirmary
City
Hull
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Facility Name
Ipswich Hospital
City
Ipswich
ZIP/Postal Code
IP4 5PD
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital
City
King's Lynn
ZIP/Postal Code
PE30 4ET
Country
United Kingdom
Facility Name
St James's University Hospital
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
University Hospitals of Leicester
City
Leicester
ZIP/Postal Code
LE5 4PW
Country
United Kingdom
Facility Name
Aintree University Hospital
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
Altnagelvin Area Hospital
City
Londonderry
ZIP/Postal Code
BT47 6SB
Country
United Kingdom
Facility Name
The Royal London Hospital
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
North Middlesex Hospital
City
London
ZIP/Postal Code
N18 1QX
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
King's College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
St George's Hospital
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Hammersmith Hospital
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Daisy Hill Hospital
City
Newry
ZIP/Postal Code
BT35 8DR
Country
United Kingdom
Facility Name
Norfolk and Norwich University Hospital
City
Norwich
ZIP/Postal Code
NR4 7UY
Country
United Kingdom
Facility Name
Nottingham City Hospital
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Churchill Hospital
City
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Facility Name
St Bartholomew's Medical Centre (OxFed)
City
Oxford
ZIP/Postal Code
OX3 9RF
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
ZIP/Postal Code
PL6 5FP
Country
United Kingdom
Facility Name
Wessex Kidney Centre
City
Portsmouth
ZIP/Postal Code
PO6 3LY
Country
United Kingdom
Facility Name
Royal Berkshire Hospital
City
Reading
ZIP/Postal Code
RG1 5AN
Country
United Kingdom
Facility Name
Queen's Hospital
City
Romford
ZIP/Postal Code
RM7 0AG
Country
United Kingdom
Facility Name
Salford Royal Hospital
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Facility Name
Northern General Hospital
City
Sheffield
ZIP/Postal Code
S5 7AU
Country
United Kingdom
Facility Name
Lister Hospital
City
Stevenage
ZIP/Postal Code
SG1 4AB
Country
United Kingdom
Facility Name
University Hospitals of North Midlands
City
Stoke-on-Trent
ZIP/Postal Code
ST4 6QG
Country
United Kingdom
Facility Name
Great Western Hospital
City
Swindon
ZIP/Postal Code
SN3 6BB
Country
United Kingdom
Facility Name
Princess Royal Hospital
City
Telford
ZIP/Postal Code
TF1 6TF
Country
United Kingdom
Facility Name
Royal Cornwall Hospital
City
Truro
ZIP/Postal Code
TR1 3LQ
Country
United Kingdom
Facility Name
Walsall Manor Hospital
City
Walsall
ZIP/Postal Code
WS2 9PS
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 URL
https://www.mystudywindow.com/msw/datasharing
Citations:
PubMed Identifier
36331190
Citation
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.
Results Reference
derived
PubMed Identifier
35472672
Citation
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.
Results Reference
derived
PubMed Identifier
34074889
Citation
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.
Results Reference
derived
PubMed Identifier
32778748
Citation
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.
Results Reference
derived
PubMed Identifier
31939531
Citation
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.
Results Reference
derived
Links:
URL
https://www.mystudywindow.com
Description
Related Info
Learn more about this trial
EMPA-KIDNEY (The Study of Heart and Kidney Protection With Empagliflozin)
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