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

Chronic Kidney Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03594110
• Other study ID #: 1245-0137
• Secondary ID: 2017-002971-24
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 31, 2019
• Est. completion date: July 5, 2024

Study information

• Verified date: March 2024
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6609
• Est. completion date: July 5, 2024
• Est. primary completion date: July 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Empagliflozin
Taken daily with or without food
• Matching placebo
Taken daily with or without food

Locations

Country	Name	City	State
Canada	LMC Clinical Research Inc. (Brampton)	Brampton	Ontario
Canada	Cambridge Cardiac Care Centre	Cambridge	Ontario
Canada	LMC Clinical Research Inc. (Thornhill)	Concord	Ontario
Canada	LMC Endocrinology Centres (Etobicoke) Ltd.	Etobicoke	Ontario
Canada	Kelowna General Hospital	Kelowna	British Columbia
Canada	London Health Science Centre, University Campus	London	Ontario
Canada	Hôpital du Sacré-Coeur de Montréal	Montreal	Quebec
Canada	Montreal Clinical Research Institute (IRCM)	Montreal	Quebec
Canada	LMC Clinical Research Inc. (Ottawa)	Nepean	Ontario
Canada	Lakeridge Health Oshawa	Oshawa	Ontario
Canada	CHU de Quebec-Universite Laval Research Centre	Quebec
Canada	IUCPQ (Laval University)	Quebec
Canada	CHUS Fleurimont	Sherbrooke	Quebec
Canada	Kidney Care Centre - Surrey	Surrey	British Columbia
Canada	LMC Clinical Research Inc. (Bayview)	Toronto	Ontario
Canada	Toronto General Hospital	Toronto	Ontario
Canada	St. Paul's Hospital	Vancouver	British Columbia
Canada	Vancouver General Hospital	Vancouver	British Columbia
Canada	Clinical Research Solutions Inc.	Waterloo	Ontario
Canada	Fadia El Boreky Medicine Professional	Waterloo	Ontario
China	Beijing AnZhen Hospital	Beijing
China	Cardiovascular Institute and Fu Wai Hospital	Beijing
China	Xiangya Hospital, Central South University	Changsha
China	Xinqiao Hospital	Chongqing
China	The Second Affiliated Hospital Zhejiang University School of Medicine	Hangzhou
China	Jinzhou Central Hospital	Jinzhou
China	Jinling Hospital	Nanjing
China	Shanghai Fifth People's Hospital affiliated to Fudan University	Shanghai
China	Huazhong University of Science and Technology Union Shenzhen Hospital	Shenzhen
China	Shenzhen People's Hospital	Shenzhen
China	People's Hospital of Sichuan Province	Sichuan
China	SuZhou Kowloon Hospital	Suzhou
China	The Central Hospital of Wuhan	Wuhan
China	Wuhan Fourth Hospital	Wuhan
China	Henan Provincial People's Hospital	Zhengzhou
China	Zhuzhou Central Hospital	Zhuzhou
China	Zhuzhou Central Hospital	Zhuzhou
Germany	Studienzentrum Aschaffenburg	Aschaffenburg
Germany	Universitätsklinikum Augsburg	Augsburg
Germany	Herz- und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen	Bad Oeynhausen
Germany	Ärztezentrum Helle Mitte	Berlin
Germany	Vivantes Netzwerk für Gesundheit GmbH	Berlin
Germany	Klinikum Bielefeld gGmbH	Bielefeld
Germany	Städtisches Klinikum Braunschweig gGmbH	Braunschweig
Germany	Universitätsklinikum Carl Gustav Carus Dresden	Dresden
Germany	Universitätsklinikum Düsseldorf	Düsseldorf
Germany	Agaplesion Markus Krankenhaus	Frankfurt
Germany	ClinPhenomics GmbH & Co KG, Frankfurt	Frankfurt
Germany	Nierenzentrum Freiburg	Freiburg
Germany	Nephrologisches Zentrum Göttingen	Göttingen
Germany	Universitätsklinikum Halle/S.	Halle
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Zentrum für Nieren-, Hochdruck und Stoffwechselerkrankungen	Hannover
Germany	Dialysezentrum Heilbronn ÜBAG für Nephrologie und Dialyse	Heilbronn
Germany	Nephrologisches Zentrum Hoyerswerda	Hoyerswerda
Germany	Universitätsklinikum Jena	Jena
Germany	Städt. Klinikum, Karlsruhe, Moltkestr.	Karlsruhe
Germany	Klinikum St. Georg gGmbH	Leipzig
Germany	Universitätsmedizin der Johannes Gutenberg-Universität Mainz	Mainz
Germany	Universitätsklinikum Mannheim GmbH	Mannheim
Germany	Nephrologisches Zentrum Mettmann	Mettmann
Germany	Klinikum der Universität München - Campus Innenstadt	München
Germany	Dialysezentrum Neckarsulm	Neckarsulm
Germany	KfH Kuratorium für Dialyse und Nierentransplantation e.V.	Nürnberg
Germany	MVZ Diaverum Potsdam	Potsdam
Germany	Universitätsklinikum Regensburg	Regensburg
Germany	Robert-Bosch-Krankenhaus GmbH	Stuttgart
Germany	Universitätsklinikum Ulm	Ulm
Germany	Nephrologisches Zentrum Velbert	Velbert
Germany	MVZ DaVita Viersen GmbH	Viersen
Germany	Nephrologisches Zentrum Villingen-Schwenningen	Villingen-Schwenningen
Germany	Gemeinschaftspraxis für Nephrologie und Rheumatologie	Wiesbaden
Germany	Universitätsklinikum Würzburg AÖR	Würzburg
Italy	Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo	Alessandria
Italy	A.O. Policlinico Giovanni XXIII di Bari	Bari
Italy	Policlinico S. Orsola Malpighi	Bologna
Italy	ASST degli Spedali Civili di Brescia	Brescia
Italy	A. O. Ospedale Civile di Vimercate e Circolo di Desio	Desio
Italy	Osp. S. Giovanni di Dio	Firenze
Italy	Ospedale S. Cuore di Gesù	Gallipoli
Italy	Azienda Ospedaliera San Martino	Genova
Italy	Ospedale della Versilia	LIDO DI Camaiore (LU)
Italy	A.O.U.Policlinico G.Martino	Messina
Italy	IRCCS San Raffaele	Milano
Italy	Milano Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico	Milano
Italy	AOU Università degli Studi della Campania Luigi Vanvitelli	Napoli
Italy	Azienda Ospedaliera Universitaria di Padova	Padova
Italy	A.O. Univ. Policlinico "Paolo Giaccone"	Palermo
Italy	Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza	Roma
Italy	Poli Univ A. Gemelli	Roma
Italy	IRCCS Ospedale "Casa Sollievo della Sofferenza"	SAN Giovanni Rotondo (FG)
Italy	Ospedale Ignazio Veris delli Ponti	Scorrano (LE)
Italy	Ospedale Martini	Torino
Italy	A.O. Univ. Integrata di Verona	Verona
Japan	Aichi Medical University Hospital	Aichi
Japan	Chubu Rosai Hospital	Aichi, Nagoya
Japan	Fukui Prefectural Hospital	Fukui City
Japan	Fukuoka University Hospital	Fukuoka, Fukuoka
Japan	Joumou Ohashi Clinic	Gumma, Maebashi
Japan	Maebashi Hirosegawa Clinic	Gunma
Japan	Ota Diabetes Clinic	Gunma
Japan	University of Tsukuba Hospital	Ibaraki, Tsukuba
Japan	Medical Corporation Seijinkai Ikeda Hospital	Kagoshima
Japan	Tokai University Hospital	Kanagawa
Japan	Koukan Clinic	Kawasaki
Japan	Kobe University Hospital	Kobe
Japan	Tohoku University Hospital	Miyagi, Sendai
Japan	Nagoya University Hospital	Nagoya
Japan	Kawasaki Medical School Hospital	Okayama, Kurashiki
Japan	Okayama University Hospital	Okayama, Okayama
Japan	AMC Nishi-umeda Clinic	Osaka
Japan	Iwasaki Internal Medicine Clinic	Osaka
Japan	Kansai Electric Power Hospital	Osaka
Japan	Shiga University of Medical Science Hospital	Shiga, Otsu
Japan	Tokyo-Eki Center-building Clinic	Tokyo
Japan	Juntendo University Hospital	Tokyo, Bunkyo-ku
Japan	The University of Tokyo Hospital	Tokyo, Bunkyo-ku
Japan	Shin Clinic	Tokyo, Ota-ku
Japan	Center Hospital of the National Center for Global Health and Medicine	Tokyo, Shinjuku-ku
Malaysia	Hospital Sultanah Bahiyah	Alor Setar, Kedah
Malaysia	Hospital Ampang	Ampang
Malaysia	University Kebangsaan Malaysia	Cheras, Kuala Lumpur
Malaysia	Hospital Pulau Pinang	Georgetown, Pulau Pinang
Malaysia	Hospital Raja Permaisuri Bainun	Ipoh, Perak
Malaysia	Hospital Sultanah Aminah	Johor Bahru
Malaysia	Hospital Kajang	Kajang, Selangor
Malaysia	Hospital Serdang	Kajang, Selangor
Malaysia	Hospital Kuala Lumpur	Kuala Lumpur
Malaysia	University of Malaya Medical Centre	Kuala Lumpur
Malaysia	Hospital Sultanah Nur Zahirah	Kuala Trengganu
Malaysia	Hospital Tengku Ampuan Afzan	Kuantan
Malaysia	Sarawak General Hospital	Kuching, Sarawak
Malaysia	Hospital Kulim	Kulim, Kedah
Malaysia	Hospital Melaka	Melaka
Malaysia	Hospital Pakar Sultanah Fatimah	Muar
Malaysia	Hospital Selayang	Selangor
Malaysia	Hospital Tuanku Ja'afar	Seremban, Negeri Sembilan
Malaysia	Pusat Perubatan UiTM Jalan Hospital	Sungai Buloh
Malaysia	Hospital Sultan Abdul Halim	Sungai Petani
Malaysia	Hospital Taiping	Taiping, Perak
United Kingdom	Antrim Area Hospital	Antrim
United Kingdom	Belfast City Hospital	Belfast
United Kingdom	Ulster Hospital	Belfast
United Kingdom	Queen Elizabeth Hospital	Birmingham
United Kingdom	Oakenhurst Medical Practice	Blackburn
United Kingdom	Royal Sussex County Hospital	Brighton
United Kingdom	Southmead Hospital	Bristol
United Kingdom	West Suffolk Hospital	Bury St Edmunds
United Kingdom	Kent & Canterbury Hospital, Oncology Department, Canterbury	Canterbury
United Kingdom	University Hospital of Wales	Cardiff
United Kingdom	St Helier Hospital	Carshalton
United Kingdom	Cheltenham General Hospital	Cheltenham
United Kingdom	Hathaway Medical Centre	Chippenham
United Kingdom	University Hospital Coventry	Coventry
United Kingdom	Darent Valley Hospital, Chemotherapy Unit	Dartford
United Kingdom	Royal Derby Hospital	Derby
United Kingdom	Dorset County Hospital	Dorchester
United Kingdom	Ninewells Hospital & Medical School	Dundee
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh
United Kingdom	Royal Devon and Exeter Hospital	Exeter
United Kingdom	Queen Elizabeth University Hospital	Glasgow
United Kingdom	Gloucestershire Royal Hospital	Gloucester
United Kingdom	Hull Royal Infirmary	Hull
United Kingdom	Ipswich Hospital	Ipswich
United Kingdom	Queen Elizabeth Hospital	King's Lynn
United Kingdom	St James's University Hospital	Leeds
United Kingdom	University Hospitals of Leicester	Leicester
United Kingdom	Aintree University Hospital	Liverpool
United Kingdom	Hammersmith Hospital	London
United Kingdom	King's College Hospital	London
United Kingdom	North Middlesex Hospital	London
United Kingdom	Royal Free Hospital	London
United Kingdom	St George's Hospital	London
United Kingdom	The Royal London Hospital	London
United Kingdom	Altnagelvin Area Hospital	Londonderry
United Kingdom	Freeman Hospital	Newcastle
United Kingdom	Daisy Hill Hospital	Newry
United Kingdom	Norfolk and Norwich University Hospital	Norwich
United Kingdom	Nottingham City Hospital	Nottingham
United Kingdom	Churchill Hospital	Oxford
United Kingdom	St Bartholomew's Medical Centre (OxFed)	Oxford
United Kingdom	Derriford Hospital	Plymouth
United Kingdom	Wessex Kidney Centre	Portsmouth
United Kingdom	Royal Berkshire Hospital	Reading
United Kingdom	Queen's Hospital	Romford
United Kingdom	Salford Royal Hospital	Salford
United Kingdom	Northern General Hospital	Sheffield
United Kingdom	Lister Hospital	Stevenage
United Kingdom	University Hospitals of North Midlands	Stoke-on-Trent
United Kingdom	Great Western Hospital	Swindon
United Kingdom	Princess Royal Hospital	Telford
United Kingdom	Royal Cornwall Hospital	Truro
United Kingdom	Walsall Manor Hospital	Walsall
United States	Mountain Kidney and Hypertension Associates, PA	Asheville	North Carolina
United States	Emory University	Atlanta	Georgia
United States	Medstar Health Research Institute	Baltimore	Maryland
United States	SUNY Downstate Medical Center	Brooklyn	New York
United States	The University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Cedar Crosse Research Center	Chicago	Illinois
United States	Northwestern University	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	Saint Elizabeth Healthcare	Covington	Kentucky
United States	Renal Disease Research Institute	Dallas	Texas
United States	Research Institute of Dallas	Dallas	Texas
United States	Midland Florida Clinical Reearch Center, LLC	DeLand	Florida
United States	Academy Of Diabetes, Thyroid And Endocrine, PA	El Paso	Texas
United States	University of Florida	Gainesville	Florida
United States	Pioneer Research Solutions, Inc.	Houston	Texas
United States	Nephrology Consultants, LLC	Huntsville	Alabama
United States	East Coast Institute for Research, LLC	Jacksonville	Florida
United States	Clinical Research Consultants, LLC	Kansas City	Missouri
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	East Coast Clinical Research, Inc	Lake City	Florida
United States	Lexington VA Health Care System - Troy Bowling Campus	Lexington	Kentucky
United States	P&I Clinical Research, LLC	Lufkin	Texas
United States	Texas Institute for Kidney and Endocrine Disorders	Lufkin	Texas
United States	The Jones Center for Diabetes and Endocrine Wellness	Macon	Georgia
United States	Aventiv Research Inc.	Mesa	Arizona
United States	Total Research Group, LLC	Miami	Florida
United States	Yale University School of Medicine	New Haven	Connecticut
United States	VA Southern Nevada Healthcare System	North Las Vegas	Nevada
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Hanson Clinical Research Center, Inc.	Port Charlotte	Florida
United States	Seacoast Kidney and Hypertension Specialists	Portsmouth	New Hampshire
United States	Regional Health Clinical Research	Rapid City	South Dakota
United States	Saint Clair Specialty Physicians	Roseville	Michigan
United States	Salem VA Medical Center	Salem	Virginia
United States	University of Utah Health Sciences Center	Salt Lake City	Utah
United States	Clinical Advancement Center PLLC	San Antonio	Texas
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Southern California Permanente Medical Group	San Diego	California
United States	Providence Medical Research Center	Spokane	Washington
United States	Carolina Diabetes & Kidney Center	Sumter	South Carolina
United States	University of California Los Angeles	Sylmar	California
United States	Chase Medical Research, LLC	Thomaston	Connecticut
United States	University of California Los Angeles	Torrance	California
United States	Kidney Care and Transplant Services of New England, PC	West Springfield	Massachusetts
United States	Brookview Hills Research Associates LLC	Winston-Salem	North Carolina
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Boehringer Ingelheim	Eli Lilly and Company, Medical Research Council Population Health Research Unit, CTSU, University of Oxford (academic lead)

Countries where clinical trial is conducted

United States,  Canada,  China,  Germany,  Italy,  Japan,  Malaysia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Follow-up period: From the day of randomisation to the day of the final follow-up visit, up to 1136 days.
Secondary	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.	Follow-up period: From the day of randomisation to the day of the final follow-up visit, up to 1140 days.
Secondary	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.	Follow-up period: From the day of randomisation to the day of the final follow-up visit, up to 1140 days.
Secondary	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.	Follow-up period: From the day of randomisation to the day of the final follow-up visit, up to 1140 days.
Secondary	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).	Follow-up period: From the day of randomisation to the day of the final follow-up visit, up to 1136 days.
Secondary	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.	Follow-up period: From the day of randomisation to the day of the final follow-up visit, up to 1140 days.
Secondary	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.	Follow-up period: From the day of randomisation to the day of the final follow-up visit, up to 1140 days.

External Links

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