Clinical trial NCT03594110: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Kidney Disease
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: University of Oxford
name: Eli Lilly and Company
First posted: 2018-07-20
Enrollment: 6609
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Interventional Part: Time to First Occurrence of Kidney Disease Progression or Cardiovascular Death ('as Adjudicated')
timeFrame: Follow-up period: From the day of randomisation to the day of the final follow-up visit, up to 1136 days.
Secondary outcomes:
measure: Key Secondary Endpoint: Interventional Part - Time to First Hospitalization for Heart Failure ('as Adjudicated') or Cardiovascular Death ('as Adjudicated')
timeFrame: Follow-up period: From the day of randomisation to the day of the final follow-up visit, up to 1140 days.
measure: Key Secondary Endpoint: Interventional Part - Time to Occurrences of All-cause Hospitalizations (First and Recurrent Combined)
timeFrame: Follow-up period: From the day of randomisation to the day of the final follow-up visit, up to 1140 days.
measure: Key Secondary Endpoint: Interventional Part - Time to Death From Any Cause ('as Adjudicated')
timeFrame: Follow-up period: From the day of randomisation to the day of the final follow-up visit, up to 1140 days.
measure: Interventional Part: Time to First Occurrence of Kidney Disease Progression
timeFrame: Follow-up period: From the day of randomisation to the day of the final follow-up visit, up to 1136 days.
measure: Interventional Part: Time to Cardiovascular Death ('as Adjudicated')
timeFrame: Follow-up period: From the day of randomisation to the day of the final follow-up visit, up to 1140 days.
measure: Interventional Part: Time to First Occurrence Cardiovascular Death ('as Adjudicated') or End Stage Kidney Disease (ESKD)
timeFrame: Follow-up period: From the day of randomisation to the day of the final follow-up visit, up to 1140 days.
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Nephrology Consultants, LLC
state: Alabama
city: Mesa
country: United States
facility: Aventiv Research, Inc
state: Arizona
city: San Diego
country: United States
facility: Southern California Permanente Medical Group
state: California
city: Sylmar
country: United States
facility: University of California Los Angeles
state: California
city: Torrance
country: United States
facility: University of California Los Angeles
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Thomaston
country: United States
facility: Chase Medical Research, LLC
state: Connecticut
city: DeLand
country: United States
facility: Midland Florida Clinical Reearch Center, LLC
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Jacksonville
country: United States
facility: East Coast Institute for Research, LLC
state: Florida
city: Lake City
country: United States
facility: East Coast Clinical Research, Inc
state: Florida
city: Miami
country: United States
facility: Total Research Group, LLC
state: Florida
city: Port Charlotte
country: United States
facility: Hanson Clinical Research Center, Inc.
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Macon
country: United States
facility: The Jones Center for Diabetes and Endocrine Wellness
state: Georgia
city: Chicago
country: United States
facility: Cedar Crosse Research Center
state: Illinois
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Covington
country: United States
facility: Saint Elizabeth Healthcare
state: Kentucky
city: Lexington
country: United States
facility: Lexington VA Health Care System - Troy Bowling Campus
state: Kentucky
city: Baltimore
country: United States
facility: Medstar Health Research Institute
state: Maryland
city: West Springfield
country: United States
facility: Kidney Care and Transplant Services of New England, PC
state: Massachusetts
city: Roseville
country: United States
facility: Saint Clair Specialty Physicians
state: Michigan
city: Kansas City
country: United States
facility: Clinical Research Consultants, LLC
state: Missouri
city: North Las Vegas
country: United States
facility: VA Southern Nevada Healthcare System
state: Nevada
city: Portsmouth
country: United States
facility: Seacoast Kidney and Hypertension Specialists
state: New Hampshire
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center
state: New York
city: Asheville
country: United States
facility: Mountain Kidney and Hypertension Associates, PA
state: North Carolina
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill
state: North Carolina
city: Winston-Salem
country: United States
facility: Brookview Hills Research Associates LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Sumter
country: United States
facility: Carolina Diabetes & Kidney Center
state: South Carolina
city: Rapid City
country: United States
facility: Regional Health Clinical Research
state: South Dakota
city: Dallas
country: United States
facility: Research Institute of Dallas
state: Texas
city: Dallas
country: United States
facility: Renal Disease Research Institute
state: Texas
city: El Paso
country: United States
facility: Academy Of Diabetes, Thyroid And Endocrine, PA
state: Texas
city: Houston
country: United States
facility: Pioneer Research Solutions, Inc.
state: Texas
city: Lufkin
country: United States
facility: P&I Clinical Research, LLC
state: Texas
city: Lufkin
country: United States
facility: Texas Institute for Kidney and Endocrine Disorders
state: Texas
city: San Antonio
country: United States
facility: Clinical Advancement Center PLLC
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Health Sciences Center
state: Utah
city: Salem
country: United States
facility: Salem VA Medical Center
state: Virginia
city: Spokane
country: United States
facility: Providence Medical Research Center
state: Washington
city: Kelowna
country: Canada
facility: Kelowna General Hospital
state: British Columbia
city: Surrey
country: Canada
facility: Kidney Care Centre - Surrey
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Brampton
country: Canada
facility: LMC Clinical Research Inc. (Brampton)
state: Ontario
city: Cambridge
country: Canada
facility: Cambridge Cardiac Care Centre
state: Ontario
city: Concord
country: Canada
facility: LMC Clinical Research Inc. (Thornhill)
state: Ontario
city: Etobicoke
country: Canada
facility: LMC Endocrinology Centres (Etobicoke) Ltd.
state: Ontario
city: London
country: Canada
facility: London Health Science Centre, University Campus
state: Ontario
city: Nepean
country: Canada
facility: LMC Clinical Research Inc. (Ottawa)
state: Ontario
city: Oshawa
country: Canada
facility: Lakeridge Health Oshawa
state: Ontario
city: Toronto
country: Canada
facility: LMC Clinical Research Inc. (Bayview)
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Waterloo
country: Canada
facility: Fadia El Boreky Medicine Professional
state: Ontario
city: Waterloo
country: Canada
facility: Clinical Research Solutions Inc.
state: Ontario
city: Montreal
country: Canada
facility: Montreal Clinical Research Institute (IRCM)
state: Quebec
city: Montreal
country: Canada
facility: Hôpital du Sacré-Coeur de Montréal
state: Quebec
city: Sherbrooke
country: Canada
facility: CHUS Hopital Fleurimont
state: Quebec
city: Quebec
country: Canada
facility: CHU de Quebec-Universite Laval Research Centre
city: Quebec
country: Canada
facility: IUCPQ (Laval University)
city: Beijing
country: China
facility: Beijing AnZhen Hospital
city: Beijing
country: China
facility: Cardiovascular Institute and Fu Wai Hospital
city: Changsha
country: China
facility: Xiangya Hospital, Central South University
city: Chongqing
country: China
facility: Xinqiao Hospital
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
city: Jinzhou
country: China
facility: Jinzhou Central Hospital
city: Nanjing
country: China
facility: Jinling Hospital
city: Shanghai
country: China
facility: Shanghai Fifth People's Hospital affiliated to Fudan University
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
city: Shenzhen
country: China
facility: Huazhong University of Science and Technology Union Shenzhen Hospital
city: Sichuan
country: China
facility: People's Hospital of Sichuan Province
city: Suzhou
country: China
facility: SuZhou Kowloon Hospital
city: Wuhan
country: China
facility: The Central Hospital of Wuhan
city: Wuhan
country: China
facility: Wuhan Fourth Hospital
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
city: Zhuzhou
country: China
facility: Zhuzhou Central Hospital
city: Zhuzhou
country: China
facility: Zhuzhou Central Hospital
city: Aschaffenburg
country: Germany
facility: Studienzentrum Aschaffenburg
city: Augsburg
country: Germany
facility: Universitätsklinikum Augsburg
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen
city: Berlin
country: Germany
facility: Vivantes Netzwerk für Gesundheit GmbH
city: Berlin
country: Germany
facility: Ärztezentrum Helle Mitte
city: Bielefeld
country: Germany
facility: Klinikum Bielefeld gGmbH
city: Braunschweig
country: Germany
facility: Städtisches Klinikum Braunschweig gGmbH
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus Dresden
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Frankfurt
country: Germany
facility: Agaplesion Markus Krankenhaus
city: Frankfurt
country: Germany
facility: ClinPhenomics GmbH & Co KG, Frankfurt
city: Freiburg
country: Germany
facility: Nierenzentrum Freiburg
city: Göttingen
country: Germany
facility: Nephrologisches Zentrum Göttingen
city: Halle
country: Germany
facility: Universitätsklinikum Halle/S.
city: Hannover
country: Germany
facility: Zentrum für Nieren-, Hochdruck und Stoffwechselerkrankungen
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Heilbronn
country: Germany
facility: Dialysezentrum Heilbronn ÜBAG für Nephrologie und Dialyse
city: Hoyerswerda
country: Germany
facility: Nephrologisches Zentrum Hoyerswerda
city: Jena
country: Germany
facility: Universitätsklinikum Jena
city: Karlsruhe
country: Germany
facility: Städt. Klinikum, Karlsruhe, Moltkestr.
city: Leipzig
country: Germany
facility: Klinikum St. Georg gGmbH
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz
city: Mannheim
country: Germany
facility: Universitätsklinikum Mannheim GmbH
city: Mettmann
country: Germany
facility: Nephrologisches Zentrum Mettmann
city: München
country: Germany
facility: Klinikum der Universität München - Campus Innenstadt
city: Neckarsulm
country: Germany
facility: Dialysezentrum Neckarsulm
city: Nürnberg
country: Germany
facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V.
city: Potsdam
country: Germany
facility: MVZ Diaverum Potsdam
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg
city: Stuttgart
country: Germany
facility: Robert-Bosch-Krankenhaus GmbH
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Velbert
country: Germany
facility: Nephrologisches Zentrum Velbert
city: Viersen
country: Germany
facility: MVZ DaVita Viersen GmbH
city: Villingen-Schwenningen
country: Germany
facility: Nephrologisches Zentrum Villingen-Schwenningen
city: Wiesbaden
country: Germany
facility: Gemeinschaftspraxis für Nephrologie und Rheumatologie
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg AÖR
city: Alessandria
country: Italy
facility: Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo
city: Bari
country: Italy
facility: A.O. Policlinico Giovanni XXIII di Bari
city: Bologna
country: Italy
facility: Policlinico S. Orsola Malpighi
city: Brescia
country: Italy
facility: ASST degli Spedali Civili di Brescia
city: Desio
country: Italy
facility: A. O. Ospedale Civile di Vimercate e Circolo di Desio
city: Firenze
country: Italy
facility: Osp. S. Giovanni di Dio
city: Gallipoli
country: Italy
facility: Ospedale S. Cuore di Gesù
city: Genova
country: Italy
facility: Azienda Ospedaliera San Martino
city: LIDO DI Camaiore (LU)
country: Italy
facility: Ospedale della Versilia
city: Messina
country: Italy
facility: A.O.U.Policlinico G.Martino
city: Milano
country: Italy
facility: Milano Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
city: Milano
country: Italy
facility: IRCCS San Raffaele
city: Napoli
country: Italy
facility: AOU Università degli Studi della Campania Luigi Vanvitelli
city: Padova
country: Italy
facility: Azienda Ospedaliera Universitaria di Padova
city: Palermo
country: Italy
facility: A.O. Univ. Policlinico "Paolo Giaccone"
city: Roma
country: Italy
facility: Poli Univ A. Gemelli
city: Roma
country: Italy
facility: Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
city: SAN Giovanni Rotondo (FG)
country: Italy
facility: IRCCS Ospedale "Casa Sollievo della Sofferenza"
city: Scorrano (LE)
country: Italy
facility: Ospedale Ignazio Veris delli Ponti
city: Torino
country: Italy
facility: Ospedale Martini
city: Verona
country: Italy
facility: A.O. Univ. Integrata di Verona
city: Aichi, Nagoya
country: Japan
facility: Chubu Rosai Hospital
city: Aichi
country: Japan
facility: Aichi Medical University Hospital
city: Fukui City
country: Japan
facility: Fukui Prefectural Hospital
city: Fukuoka, Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Gumma, Maebashi
country: Japan
facility: Joumou Ohashi Clinic
city: Gunma
country: Japan
facility: Maebashi Hirosegawa Clinic
city: Gunma
country: Japan
facility: Ota Diabetes Clinic
city: Ibaraki, Tsukuba
country: Japan
facility: University of Tsukuba Hospital
city: Kagoshima
country: Japan
facility: Medical Corporation Seijinkai Ikeda Hospital
city: Kanagawa
country: Japan
facility: Tokai University Hospital
city: Kawasaki
country: Japan
facility: Koukan Clinic
city: Kobe
country: Japan
facility: Kobe University Hospital
city: Miyagi, Sendai
country: Japan
facility: Tohoku University Hospital
city: Nagoya
country: Japan
facility: Nagoya University Hospital
city: Okayama, Kurashiki
country: Japan
facility: Kawasaki Medical School Hospital
city: Okayama, Okayama
country: Japan
facility: Okayama University Hospital
city: Osaka
country: Japan
facility: AMC Nishi-umeda Clinic
city: Osaka
country: Japan
facility: Kansai Electric Power Hospital
city: Osaka
country: Japan
facility: Iwasaki Internal Medicine Clinic
city: Shiga, Otsu
country: Japan
facility: Shiga University of Medical Science Hospital
city: Tokyo, Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
city: Tokyo, Bunkyo-ku
country: Japan
facility: The University of Tokyo Hospital
city: Tokyo, Ota-ku
country: Japan
facility: Shin Clinic
city: Tokyo, Shinjuku-ku
country: Japan
facility: Center Hospital of the National Center for Global Health and Medicine
city: Tokyo
country: Japan
facility: Tokyo-Eki Center-building Clinic
city: Alor Setar, Kedah
country: Malaysia
facility: Hospital Sultanah Bahiyah
city: Ampang
country: Malaysia
facility: Hospital Ampang
city: Cheras, Kuala Lumpur
country: Malaysia
facility: University Kebangsaan Malaysia
city: Georgetown, Pulau Pinang
country: Malaysia
facility: Hospital Pulau Pinang
city: Ipoh, Perak
country: Malaysia
facility: Hospital Raja Permaisuri Bainun
city: Johor Bahru
country: Malaysia
facility: Hospital Sultanah Aminah
city: Kajang, Selangor
country: Malaysia
facility: Hospital Kajang
city: Kajang, Selangor
country: Malaysia
facility: Hospital Serdang
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
city: Kuala Lumpur
country: Malaysia
facility: University of Malaya Medical Centre
city: Kuala Trengganu
country: Malaysia
facility: Hospital Sultanah Nur Zahirah
city: Kuantan
country: Malaysia
facility: Hospital Tengku Ampuan Afzan
city: Kuching, Sarawak
country: Malaysia
facility: Sarawak General Hospital
city: Kulim, Kedah
country: Malaysia
facility: Hospital Kulim
city: Melaka
country: Malaysia
facility: Hospital Melaka
city: Muar
country: Malaysia
facility: Hospital Pakar Sultanah Fatimah
city: Selangor
country: Malaysia
facility: Hospital Selayang
city: Seremban, Negeri Sembilan
country: Malaysia
facility: Hospital Tuanku Ja'afar
city: Sungai Buloh
country: Malaysia
facility: Pusat Perubatan UiTM Jalan Hospital
city: Sungai Petani
country: Malaysia
facility: Hospital Sultan Abdul Halim
city: Taiping, Perak
country: Malaysia
facility: Hospital Taiping
city: Antrim
country: United Kingdom
facility: Antrim Area Hospital
city: Belfast
country: United Kingdom
facility: Ulster Hospital
city: Belfast
country: United Kingdom
facility: Belfast City Hospital
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Blackburn
country: United Kingdom
facility: Oakenhurst Medical Practice
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
city: Bristol
country: United Kingdom
facility: Southmead Hospital
city: Bury St Edmunds
country: United Kingdom
facility: West Suffolk Hospital
city: Canterbury
country: United Kingdom
facility: Kent & Canterbury Hospital, Oncology Department, Canterbury
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
city: Carshalton
country: United Kingdom
facility: St Helier Hospital
city: Cheltenham
country: United Kingdom
facility: Cheltenham General Hospital
city: Chippenham
country: United Kingdom
facility: Hathaway Medical Centre
city: Coventry
country: United Kingdom
facility: University Hospital Coventry
city: Dartford
country: United Kingdom
facility: Darent Valley Hospital, Chemotherapy Unit
city: Derby
country: United Kingdom
facility: Royal Derby Hospital
city: Dorchester
country: United Kingdom
facility: Dorset County Hospital
city: Dundee
country: United Kingdom
facility: Ninewells Hospital & Medical School
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
city: Gloucester
country: United Kingdom
facility: Gloucestershire Royal Hospital
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary
city: Ipswich
country: United Kingdom
facility: Ipswich Hospital
city: King's Lynn
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Leeds
country: United Kingdom
facility: St James's University Hospital
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester
city: Liverpool
country: United Kingdom
facility: Aintree University Hospital
city: Londonderry
country: United Kingdom
facility: Altnagelvin Area Hospital
city: London
country: United Kingdom
facility: The Royal London Hospital
city: London
country: United Kingdom
facility: North Middlesex Hospital
city: London
country: United Kingdom
facility: Royal Free Hospital
city: London
country: United Kingdom
facility: King's College Hospital
city: London
country: United Kingdom
facility: St George's Hospital
city: London
country: United Kingdom
facility: Hammersmith Hospital
city: Newcastle
country: United Kingdom
facility: Freeman Hospital
city: Newry
country: United Kingdom
facility: Daisy Hill Hospital
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital
city: Oxford
country: United Kingdom
facility: Churchill Hospital
city: Oxford
country: United Kingdom
facility: St Bartholomew's Medical Centre (OxFed)
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
city: Portsmouth
country: United Kingdom
facility: Wessex Kidney Centre
city: Reading
country: United Kingdom
facility: Royal Berkshire Hospital
city: Romford
country: United Kingdom
facility: Queen's Hospital
city: Salford
country: United Kingdom
facility: Salford Royal Hospital
city: Sheffield
country: United Kingdom
facility: Northern General Hospital
city: Stevenage
country: United Kingdom
facility: Lister Hospital
city: Stoke-on-Trent
country: United Kingdom
facility: University Hospitals of North Midlands
city: Swindon
country: United Kingdom
facility: Great Western Hospital
city: Telford
country: United Kingdom
facility: Princess Royal Hospital
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
city: Walsall
country: United Kingdom
facility: Walsall Manor Hospital
Study officials:
References:
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.
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.
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