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Clinical Trial Details

Trial ID: L0202
Source ID: NCT03594110
Associated Drug: Empagliflozin
Title: EMPA-KIDNEY (The Study of Heart and Kidney Protection With Empagliflozin)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03594110/results
Conditions: Chronic Kidney Disease
Interventions: DRUG: Empagliflozin|DRUG: Matching placebo
Outcome Measures: 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.|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.|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.|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.|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.|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.
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim | Collaborators: University of Oxford|Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 6609
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2019-01-31
Completion Date: 2024-07-02
Results First Posted: 2023-07-27
Last Update Posted: 2025-02-11
Locations: Nephrology Consultants, LLC, Huntsville, Alabama, 35805, United States|Aventiv Research, Inc, Mesa, Arizona, 85210, United States|Southern California Permanente Medical Group, San Diego, California, 92123, United States|University of California Los Angeles, Sylmar, California, 91342, United States|University of California Los Angeles, Torrance, California, 90502, United States|Yale University School of Medicine, New Haven, Connecticut, 06510, United States|Chase Medical Research, LLC, Thomaston, Connecticut, 06787, United States|Midland Florida Clinical Reearch Center, LLC, DeLand, Florida, 32720, United States|University of Florida, Gainesville, Florida, 32610, United States|East Coast Institute for Research, LLC, Jacksonville, Florida, 32216, United States|East Coast Clinical Research, Inc, Lake City, Florida, 32055, United States|Total Research Group, LLC, Miami, Florida, 33126, United States|Hanson Clinical Research Center, Inc., Port Charlotte, Florida, 33952, United States|Emory University, Atlanta, Georgia, 30322, United States|The Jones Center for Diabetes and Endocrine Wellness, Macon, Georgia, 31210, United States|Cedar Crosse Research Center, Chicago, Illinois, 60607, United States|Northwestern University, Chicago, Illinois, 60611, United States|University of Kansas Medical Center, Kansas City, Kansas, 66160, United States|Saint Elizabeth Healthcare, Covington, Kentucky, 41011, United States|Lexington VA Health Care System - Troy Bowling Campus, Lexington, Kentucky, 40502, United States|Medstar Health Research Institute, Baltimore, Maryland, 21239, United States|Kidney Care and Transplant Services of New England, PC, West Springfield, Massachusetts, 01089, United States|Saint Clair Specialty Physicians, Roseville, Michigan, 48066, United States|Clinical Research Consultants, LLC, Kansas City, Missouri, 64111, United States|VA Southern Nevada Healthcare System, North Las Vegas, Nevada, 89086, United States|Seacoast Kidney and Hypertension Specialists, Portsmouth, New Hampshire, 03801, United States|SUNY Downstate Medical Center, Brooklyn, New York, 11203, United States|Mountain Kidney and Hypertension Associates, PA, Asheville, North Carolina, 28801, United States|The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27514, United States|Brookview Hills Research Associates LLC, Winston-Salem, North Carolina, 27103, United States|Wake Forest University Health Sciences, Winston-Salem, North Carolina, 27157, United States|University Hospitals of Cleveland, Cleveland, Ohio, 44106, United States|Cleveland Clinic, Cleveland, Ohio, 44195, United States|Thomas Jefferson University, Philadelphia, Pennsylvania, 19114, United States|Carolina Diabetes & Kidney Center, Sumter, South Carolina, 29150, United States|Regional Health Clinical Research, Rapid City, South Dakota, 57701, United States|Research Institute of Dallas, Dallas, Texas, 75231, United States|Renal Disease Research Institute, Dallas, Texas, 75246, United States|Academy Of Diabetes, Thyroid And Endocrine, PA, El Paso, Texas, 79935, United States|Pioneer Research Solutions, Inc., Houston, Texas, 77099, United States|P&I Clinical Research, LLC, Lufkin, Texas, 75904, United States|Texas Institute for Kidney and Endocrine Disorders, Lufkin, Texas, 75904, United States|Clinical Advancement Center PLLC, San Antonio, Texas, 78212, United States|University of Texas Health Science Center at San Antonio, San Antonio, Texas, 78229, United States|University of Utah Health Sciences Center, Salt Lake City, Utah, 84108, United States|Salem VA Medical Center, Salem, Virginia, 24153, United States|Providence Medical Research Center, Spokane, Washington, 99204, United States|Kelowna General Hospital, Kelowna, British Columbia, V1Y 1T2, Canada|Kidney Care Centre - Surrey, Surrey, British Columbia, V3T 5H6, Canada|Vancouver General Hospital, Vancouver, British Columbia, V5Z 1M9, Canada|St. Paul's Hospital, Vancouver, British Columbia, V6Z 1Y6, Canada|LMC Clinical Research Inc. (Brampton), Brampton, Ontario, L6S 0C6, Canada|Cambridge Cardiac Care Centre, Cambridge, Ontario, N1R 6V6, Canada|LMC Clinical Research Inc. (Thornhill), Concord, Ontario, L4K 4M2, Canada|LMC Endocrinology Centres (Etobicoke) Ltd., Etobicoke, Ontario, M9R 4E1, Canada|London Health Science Centre, University Campus, London, Ontario, N6A 4G5, Canada|LMC Clinical Research Inc. (Ottawa), Nepean, Ontario, K2J 0V2, Canada|Lakeridge Health Oshawa, Oshawa, Ontario, L1G 2B9, Canada|LMC Clinical Research Inc. (Bayview), Toronto, Ontario, M4G 3E8, Canada|Toronto General Hospital, Toronto, Ontario, M5G 2N2, Canada|Fadia El Boreky Medicine Professional, Waterloo, Ontario, N2J 1C4, Canada|Clinical Research Solutions Inc., Waterloo, Ontario, N2J 3Z4, Canada|Montreal Clinical Research Institute (IRCM), Montreal, Quebec, H2W 1R7, Canada|Hôpital du Sacré-Coeur de Montréal, Montreal, Quebec, H4J 1C5, Canada|CHUS Hopital Fleurimont, Sherbrooke, Quebec, J1H 5N4, Canada|CHU de Quebec-Universite Laval Research Centre, Quebec, G1R 2J6, Canada|IUCPQ (Laval University), Quebec, G1V 4G5, Canada|Beijing AnZhen Hospital, Beijing, 100029, China|Cardiovascular Institute and Fu Wai Hospital, Beijing, 100037, China|Xiangya Hospital, Central South University, Changsha, 410008, China|Xinqiao Hospital, Chongqing, 400037, China|The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, 310000, China|Jinzhou Central Hospital, Jinzhou, 121000, China|Jinling Hospital, Nanjing, 210002, China|Shanghai Fifth People's Hospital affiliated to Fudan University, Shanghai, 200240, China|Shenzhen People's Hospital, Shenzhen, 518020, China|Huazhong University of Science and Technology Union Shenzhen Hospital, Shenzhen, 518052, China|People's Hospital of Sichuan Province, Sichuan, 610031, China|SuZhou Kowloon Hospital, Suzhou, 215000, China|The Central Hospital of Wuhan, Wuhan, 430014, China|Wuhan Fourth Hospital, Wuhan, 430033, China|Henan Provincial People's Hospital, Zhengzhou, 450003, China|Zhuzhou Central Hospital, Zhuzhou, 412000, China|Zhuzhou Central Hospital, Zhuzhou, 412007, China|Studienzentrum Aschaffenburg, Aschaffenburg, 63739, Germany|Universitätsklinikum Augsburg, Augsburg, 86156, Germany|Herz- und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen, Bad Oeynhausen, 32545, Germany|Vivantes Netzwerk für Gesundheit GmbH, Berlin, 12351, Germany|Ärztezentrum Helle Mitte, Berlin, 12627, Germany|Klinikum Bielefeld gGmbH, Bielefeld, 33604, Germany|Städtisches Klinikum Braunschweig gGmbH, Braunschweig, 38126, Germany|Universitätsklinikum Carl Gustav Carus Dresden, Dresden, 01307, Germany|Universitätsklinikum Düsseldorf, Düsseldorf, 40225, Germany|Agaplesion Markus Krankenhaus, Frankfurt, 60431, Germany|ClinPhenomics GmbH & Co KG, Frankfurt, Frankfurt, 60594, Germany|Nierenzentrum Freiburg, Freiburg, 79100, Germany|Nephrologisches Zentrum Göttingen, Göttingen, 37075, Germany|Universitätsklinikum Halle/S., Halle, 06120, Germany|Zentrum für Nieren-, Hochdruck und Stoffwechselerkrankungen, Hannover, 30453, Germany|Medizinische Hochschule Hannover, Hannover, 30625, Germany|Dialysezentrum Heilbronn ÜBAG für Nephrologie und Dialyse, Heilbronn, 74075, Germany|Nephrologisches Zentrum Hoyerswerda, Hoyerswerda, 02977, Germany|Universitätsklinikum Jena, Jena, 07747, Germany|Städt. Klinikum, Karlsruhe, Moltkestr., Karlsruhe, 76133, Germany|Klinikum St. Georg gGmbH, Leipzig, 04129, Germany|Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz, 55131, Germany|Universitätsklinikum Mannheim GmbH, Mannheim, 68167, Germany|Nephrologisches Zentrum Mettmann, Mettmann, 40822, Germany|Klinikum der Universität München - Campus Innenstadt, München, 80337, Germany|Dialysezentrum Neckarsulm, Neckarsulm, 74172, Germany|KfH Kuratorium für Dialyse und Nierentransplantation e.V., Nürnberg, 90471, Germany|MVZ Diaverum Potsdam, Potsdam, 14469, Germany|Universitätsklinikum Regensburg, Regensburg, 93053, Germany|Robert-Bosch-Krankenhaus GmbH, Stuttgart, 70376, Germany|Universitätsklinikum Ulm, Ulm, 89081, Germany|Nephrologisches Zentrum Velbert, Velbert, 42549, Germany|MVZ DaVita Viersen GmbH, Viersen, 41751, Germany|Nephrologisches Zentrum Villingen-Schwenningen, Villingen-Schwenningen, 78052, Germany|Gemeinschaftspraxis für Nephrologie und Rheumatologie, Wiesbaden, 65191, Germany|Universitätsklinikum Würzburg AÖR, Würzburg, 97080, Germany|Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo, Alessandria, 15121, Italy|A.O. Policlinico Giovanni XXIII di Bari, Bari, 70124, Italy|Policlinico S. Orsola Malpighi, Bologna, 40138, Italy|ASST degli Spedali Civili di Brescia, Brescia, 25123, Italy|A. O. Ospedale Civile di Vimercate e Circolo di Desio, Desio, 20832, Italy|Osp. S. Giovanni di Dio, Firenze, 50143, Italy|Ospedale S. Cuore di Gesù, Gallipoli, 73014, Italy|Azienda Ospedaliera San Martino, Genova, 16132, Italy|Ospedale della Versilia, LIDO DI Camaiore (LU), 55043, Italy|A.O.U.Policlinico G.Martino, Messina, 98124, Italy|Milano Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico, Milano, 20122, Italy|IRCCS San Raffaele, Milano, 20132, Italy|AOU Università degli Studi della Campania Luigi Vanvitelli, Napoli, 80138, Italy|Azienda Ospedaliera Universitaria di Padova, Padova, 35128, Italy|A.O. Univ. Policlinico "Paolo Giaccone", Palermo, 90127, Italy|Poli Univ A. Gemelli, Roma, 00168, Italy|Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza, Roma, 00189, Italy|IRCCS Ospedale "Casa Sollievo della Sofferenza", SAN Giovanni Rotondo (FG), 71013, Italy|Ospedale Ignazio Veris delli Ponti, Scorrano (LE), 73020, Italy|Ospedale Martini, Torino, 10141, Italy|A.O. Univ. Integrata di Verona, Verona, 37126, Italy|Chubu Rosai Hospital, Aichi, Nagoya, 455-8530, Japan|Aichi Medical University Hospital, Aichi, 480-1195, Japan|Fukui Prefectural Hospital, Fukui City, 910-8526, Japan|Fukuoka University Hospital, Fukuoka, Fukuoka, 814-0180, Japan|Joumou Ohashi Clinic, Gumma, Maebashi, 371-0046, Japan|Maebashi Hirosegawa Clinic, Gunma, 371-0022, Japan|Ota Diabetes Clinic, Gunma, 373-0861, Japan|University of Tsukuba Hospital, Ibaraki, Tsukuba, 305-8576, Japan|Medical Corporation Seijinkai Ikeda Hospital, Kagoshima, 893-0024, Japan|Tokai University Hospital, Kanagawa, 259-1193, Japan|Koukan Clinic, Kawasaki, 210-0852, Japan|Kobe University Hospital, Kobe, 650-0017, Japan|Tohoku University Hospital, Miyagi, Sendai, 980-8547, Japan|Nagoya University Hospital, Nagoya, 466-8560, Japan|Kawasaki Medical School Hospital, Okayama, Kurashiki, 701-0192, Japan|Okayama University Hospital, Okayama, Okayama, 700-8558, Japan|AMC Nishi-umeda Clinic, Osaka, 530-0001, Japan|Kansai Electric Power Hospital, Osaka, 553-0003, Japan|Iwasaki Internal Medicine Clinic, Osaka, 577-0802, Japan|Shiga University of Medical Science Hospital, Shiga, Otsu, 520-2192, Japan|Juntendo University Hospital, Tokyo, Bunkyo-ku, 113-8431, Japan|The University of Tokyo Hospital, Tokyo, Bunkyo-ku, 113-8655, Japan|Shin Clinic, Tokyo, Ota-ku, 144-0051, Japan|Center Hospital of the National Center for Global Health and Medicine, Tokyo, Shinjuku-ku, 162-8555, Japan|Tokyo-Eki Center-building Clinic, Tokyo, 103-0027, Japan|Hospital Sultanah Bahiyah, Alor Setar, Kedah, 05460, Malaysia|Hospital Ampang, Ampang, 68000, Malaysia|University Kebangsaan Malaysia, Cheras, Kuala Lumpur, 56000, Malaysia|Hospital Pulau Pinang, Georgetown, Pulau Pinang, 10450, Malaysia|Hospital Raja Permaisuri Bainun, Ipoh, Perak, 30450, Malaysia|Hospital Sultanah Aminah, Johor Bahru, 80100, Malaysia|Hospital Kajang, Kajang, Selangor, 43000, Malaysia|Hospital Serdang, Kajang, Selangor, 43000, Malaysia|Hospital Kuala Lumpur, Kuala Lumpur, 50586, Malaysia|University of Malaya Medical Centre, Kuala Lumpur, 59100, Malaysia|Hospital Sultanah Nur Zahirah, Kuala Trengganu, 20400, Malaysia|Hospital Tengku Ampuan Afzan, Kuantan, 25100, Malaysia|Sarawak General Hospital, Kuching, Sarawak, 93586, Malaysia|Hospital Kulim, Kulim, Kedah, 9000, Malaysia|Hospital Melaka, Melaka, 75400, Malaysia|Hospital Pakar Sultanah Fatimah, Muar, 84000, Malaysia|Hospital Selayang, Selangor, 68100, Malaysia|Hospital Tuanku Ja'afar, Seremban, Negeri Sembilan, 70300, Malaysia|Pusat Perubatan UiTM Jalan Hospital, Sungai Buloh, 47000, Malaysia|Hospital Sultan Abdul Halim, Sungai Petani, 8000, Malaysia|Hospital Taiping, Taiping, Perak, 34000, Malaysia|Antrim Area Hospital, Antrim, BT41 2RL, United Kingdom|Ulster Hospital, Belfast, BT16 1RH, United Kingdom|Belfast City Hospital, Belfast, BT9 7AB, United Kingdom|Queen Elizabeth Hospital, Birmingham, B15 2TH, United Kingdom|Oakenhurst Medical Practice, Blackburn, BB2 1AX, United Kingdom|Royal Sussex County Hospital, Brighton, BN2 5BE, United Kingdom|Southmead Hospital, Bristol, BS10 5NB, United Kingdom|West Suffolk Hospital, Bury St Edmunds, IP33 2QZ, United Kingdom|Kent & Canterbury Hospital, Oncology Department, Canterbury, Canterbury, CT1 3NG, United Kingdom|University Hospital of Wales, Cardiff, CF14 4XW, United Kingdom|St Helier Hospital, Carshalton, SM5 1AA, United Kingdom|Cheltenham General Hospital, Cheltenham, GL53 7AN, United Kingdom|Hathaway Medical Centre, Chippenham, SN14 6GT, United Kingdom|University Hospital Coventry, Coventry, CV2 2DX, United Kingdom|Darent Valley Hospital, Chemotherapy Unit, Dartford, DA2 8DA, United Kingdom|Royal Derby Hospital, Derby, DE22 3NE, United Kingdom|Dorset County Hospital, Dorchester, DT1 2JY, United Kingdom|Ninewells Hospital & Medical School, Dundee, DD1 9SY, United Kingdom|Royal Infirmary of Edinburgh, Edinburgh, EH16 4SA, United Kingdom|Royal Devon and Exeter Hospital, Exeter, EX2 5DW, United Kingdom|Queen Elizabeth University Hospital, Glasgow, G51 4TF, United Kingdom|Gloucestershire Royal Hospital, Gloucester, GL1 3NN, United Kingdom|Hull Royal Infirmary, Hull, HU3 2JZ, United Kingdom|Ipswich Hospital, Ipswich, IP4 5PD, United Kingdom|Queen Elizabeth Hospital, King's Lynn, PE30 4ET, United Kingdom|St James's University Hospital, Leeds, LS9 7TF, United Kingdom|University Hospitals of Leicester, Leicester, LE5 4PW, United Kingdom|Aintree University Hospital, Liverpool, L9 7AL, United Kingdom|Altnagelvin Area Hospital, Londonderry, BT47 6SB, United Kingdom|The Royal London Hospital, London, E1 1BB, United Kingdom|North Middlesex Hospital, London, N18 1QX, United Kingdom|Royal Free Hospital, London, NW3 2QG, United Kingdom|King's College Hospital, London, SE5 9RS, United Kingdom|St George's Hospital, London, SW17 0QT, United Kingdom|Hammersmith Hospital, London, W12 0HS, United Kingdom|Freeman Hospital, Newcastle, NE7 7DN, United Kingdom|Daisy Hill Hospital, Newry, BT35 8DR, United Kingdom|Norfolk and Norwich University Hospital, Norwich, NR4 7UY, United Kingdom|Nottingham City Hospital, Nottingham, NG5 1PB, United Kingdom|Churchill Hospital, Oxford, OX3 7LE, United Kingdom|St Bartholomew's Medical Centre (OxFed), Oxford, OX3 9RF, United Kingdom|Derriford Hospital, Plymouth, PL6 5FP, United Kingdom|Wessex Kidney Centre, Portsmouth, PO6 3LY, United Kingdom|Royal Berkshire Hospital, Reading, RG1 5AN, United Kingdom|Queen's Hospital, Romford, RM7 0AG, United Kingdom|Salford Royal Hospital, Salford, M6 8HD, United Kingdom|Northern General Hospital, Sheffield, S5 7AU, United Kingdom|Lister Hospital, Stevenage, SG1 4AB, United Kingdom|University Hospitals of North Midlands, Stoke-on-Trent, ST4 6QG, United Kingdom|Great Western Hospital, Swindon, SN3 6BB, United Kingdom|Princess Royal Hospital, Telford, TF1 6TF, United Kingdom|Royal Cornwall Hospital, Truro, TR1 3LQ, United Kingdom|Walsall Manor Hospital, Walsall, WS2 9PS, United Kingdom
URL: https://clinicaltrials.gov/show/NCT03594110