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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03594110
Recruitment Status : Recruiting
First Posted : July 20, 2018
Last Update Posted : November 27, 2019
Sponsor:
Collaborators:
Medical Research Council Population Health Research Unit, CTSU, University of Oxford (academic lead)
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: Empagliflozin Drug: Matching placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : January 31, 2019
Estimated Primary Completion Date : June 2, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Empagliflozin Drug: Empagliflozin
Taken daily with or without food

Placebo Comparator: Placebo Drug: Matching placebo
Taken daily with or without food




Primary Outcome Measures :
  1. Composite primary outcome:Time to first occurrence of (i) kidney disease progression (defined as ESKD, a sustained decline in eGFR to <10 mL/min/1.73m², renal death, or a sustained decline of ≥40% in eGFR from randomization) or (ii) Cardiovascular death [ Time Frame: Median follow-up approx. 3.1 years ]
    End Stage Kidney Disease (ESKD) is defined as the initiation of maintenance dialysis or receipt of a kidney transplant


Secondary Outcome Measures :
  1. Time to first hospitalization for heart failure or cardiovascular death [ Time Frame: Median follow-up approx. 3.1 years ]
  2. Occurrences of all-cause hospitalization (first and recurrent) [ Time Frame: Median follow-up approx. 3.1 years ]
  3. Time to death from any cause [ Time Frame: Median follow-up approx. 3.1 years ]
  4. Time to first occurrence of kidney disease progression [ Time Frame: Median follow-up approx. 3.1 years ]
  5. Time to cardiovascular death [ Time Frame: Median follow-up approx. 3.1 years ]
  6. Time to cardiovascular death or ESKD [ Time Frame: Median follow-up approx. 3.1 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Neither requires an 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 disease with an eGFR >60 mL/min/1.73m² ;
  • Receiving dual RAS inhibition (two of ACEi, ARB, DRI);
  • Any immunosuppression therapy in last 3 months (except prednisolone ≤10 mg or equivalent); or anyone currently on >10 mg prednisolone (or equivalent)
  • 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 hypotension, or systolic blood pressure <90 or >180 mmHg;
  • ALT or AST >3x ULN;
  • Hypersensitivity to empagliflozin or other SGLT-2 inhibitor;
  • Known to be poorly compliant with clinic visits or prescribed medication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03594110


Contacts
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Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com
Contact: CTSU University of Oxford +44(0)1865743868 cco.empakidney@ndph.ox.ac.uk

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Locations
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United States, California
University of California Los Angeles Recruiting
Sylmar, California, United States, 91342
University of California Los Angeles Recruiting
Torrance, California, United States, 90502
United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06510
United States, Florida
East Coast Institute for Research, LLC Recruiting
Jacksonville, Florida, United States, 32216
Hanson Clinical Research Center Recruiting
Port Charlotte, Florida, United States, 33952
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
United States, Massachusetts
Kidney Care and Transplant Services of New England, PC Recruiting
Springfield, Massachusetts, United States, 01107
United States, Michigan
Saint Clair Specialty Physicians Recruiting
Roseville, Michigan, United States, 48066
United States, New Hampshire
Seacoast Kidney and Hypertension Specialists Recruiting
Portsmouth, New Hampshire, United States, 03801
United States, North Carolina
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
University Hospitals of Cleveland Recruiting
Cleveland, Ohio, United States, 44106
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19114
United States, South Carolina
Carolina Diabetes & Kidney Center Recruiting
Sumter, South Carolina, United States, 29150
United States, South Dakota
Regional Health Clinical Research Recruiting
Rapid City, South Dakota, United States, 57701
United States, Texas
Research Institute of Dallas Recruiting
Dallas, Texas, United States, 75231
Renal Disease Research Institute Recruiting
Dallas, Texas, United States, 75246
Academy Of Diabetes, Thyroid And Endocrine, PA Recruiting
El Paso, Texas, United States, 79935
Texas Institute for Kidney and Endocrine Disorders Recruiting
Lufkin, Texas, United States, 75904
University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229
United States, Utah
University of Utah Health Sciences Center Recruiting
Salt Lake City, Utah, United States, 84108
United States, Washington
Providence Medical Research Center Recruiting
Spokane, Washington, United States, 99204
Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
St. Paul's Hospital Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Ontario
LMC Clinical Research Inc. (Brampton) Recruiting
Brampton, Ontario, Canada, L6S 0C6
Cambridge Cardiac Care Inc. Recruiting
Cambridge, Ontario, Canada, N1R 6V6
LMC Clinical Research Inc. (Thornhill) Recruiting
Concord, Ontario, Canada, L4K 4M2
LMC Clinical Research Inc. (Ottawa) Recruiting
Nepean, Ontario, Canada, K2J 0V2
LMC Clinical Research Inc. (Bayview) Recruiting
Toronto, Ontario, Canada, M4G 3E8
Fadia El Boreky Medicine Professional Recruiting
Waterloo, Ontario, Canada, N2J 1C4
Germany
Studienzentrum Aschaffenburg Recruiting
Aschaffenburg, Germany, 63739
Herz- und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen Recruiting
Bad Oeynhausen, Germany, 32545
Vivantes Netzwerk für Gesundheit GmbH Recruiting
Berlin, Germany, 12351
Ärztezentrum Helle Mitte Recruiting
Berlin, Germany, 12627
Klinikum Bielefeld gGmbH Recruiting
Bielefeld, Germany, 33604
Universitätsklinikum Carl Gustav Carus Dresden Recruiting
Dresden, Germany, 01307
Universitätsklinikum Düsseldorf Recruiting
Düsseldorf, Germany, 40225
ClinPhenomics GmbH & Co KG, Frankfurt Recruiting
Frankfurt, Germany, 60594
Nierenzentrum Freiburg Recruiting
Freiburg, Germany, 79100
Nephrologisches Zentrum Göttingen Recruiting
Göttingen, Germany, 37075
Zentrum für Nieren-, Hochdruck und Stoffwechselerkrankungen Recruiting
Hannover, Germany, 30453
Dialysezentrum Heilbronn ÜBAG für Nephrologie und Dialyse Recruiting
Heilbronn, Germany, 74075
Nephrologisches Zentrum Hoyerswerda Terminated
Hoyerswerda, Germany
Universitätsklinikum Jena Recruiting
Jena, Germany, 07747
Klinikum St. Georg gGmbH Recruiting
Leipzig, Germany, 4129
Universitätsmedizin der Johannes Gutenberg-Universität Mainz Recruiting
Mainz, Germany, 55131
Universitätsklinikum Mannheim GmbH Recruiting
Mannheim, Germany, 68167
Nephrologisches Zentrum Mettmann Recruiting
Mettmann, Germany, 40822
Klinikum der Universität München - Campus Innenstadt Recruiting
München, Germany, 80337
Dialysezentrum Neckarsulm Recruiting
Neckarsulm, Germany, 74172
KfH Kuratorium für Dialyse und Nierentransplantation e.V. Recruiting
Nürnberg, Germany, 90471
MVZ Diaverum Potsdam Recruiting
Potsdam, Germany, 14469
Robert-Bosch-Krankenhaus GmbH Recruiting
Stuttgart, Germany, 70376
Universitätsklinikum Ulm Recruiting
Ulm, Germany, 89081
Nephrologisches Zentrum Velbert Recruiting
Velbert, Germany, 42549
Nephrologisches Zentrum Villingen-Schwenningen Recruiting
Villingen-Schwenningen, Germany, 78052
Gemeinschaftspraxis für Nephrologie und Rheumatologie Recruiting
Wiesbaden, Germany, 65191
Universitätsklinikum Würzburg Recruiting
Würzburg, Germany, 97080
Japan
Aichi Medical University Hospital Recruiting
Aichi, Japan, 480-1195
Fukui Prefectural Hospital Recruiting
Fukui City, Japan, 910-8526
Maebashi Hirosegawa Clinic Recruiting
Gunma, Japan, 371-0022
Ota Diabetes Clinic Recruiting
Gunma, Japan, 373-0861
Medical Corporation Seijinkai Ikeda Hospital Recruiting
Kagoshima, Japan, 893-0024
Tokai University Hospital Recruiting
Kanagawa, Japan, 259-1193
Kawasaki Medical School Hospital Recruiting
Okayama, Kurashiki, Japan, 701-0192
Okayama University Hospital Recruiting
Okayama, Okayama, Japan, 700-8558
AMC Nishi-umeda Clinic Recruiting
Osaka, Japan, 530-0001
Kansai Electric Power Hospital Recruiting
Osaka, Japan, 553-0003
Iwasaki Internal Medicine Clinic Recruiting
Osaka, Japan, 577-0802
Juntendo University Hospital Recruiting
Tokyo, Bunkyo-ku, Japan, 113-8431
The University of Tokyo Hospital Recruiting
Tokyo, Bunkyo-ku, Japan, 113-8655
Shin Clinic Recruiting
Tokyo, Ota-ku, Japan, 144-0051
Global Health and Medicine Ctr Recruiting
Tokyo, Shinjuku-ku, Japan, 162-8555
Malaysia
Hospital Sultanah Bahiyah Recruiting
Alor Setar, Kedah, Malaysia, 05460
Hospital Ampang Recruiting
Ampang, Malaysia, 68000
University Kebangsaan Malaysia Recruiting
Cheras, Kuala Lumpur, Malaysia, 56000
Hospital Pulau Pinang Recruiting
Georgetown, Pulau Pinang, Malaysia, 10450
Hospital Raja Permaisuri Bainun Recruiting
Ipoh, Perak, Malaysia, 30450
Hospital Sultanah Aminah Recruiting
Johor Bahru, Malaysia, 80100
Hospital Kajang Recruiting
Kajang, Selangor, Malaysia, 43000
Hospital Serdang Recruiting
Kajang, Selangor, Malaysia, 43000
Hospital Kuala Lumpur Recruiting
Kuala Lumpur, Malaysia, 50586
University Malaya Medical Centre Recruiting
Kuala Lumpur, Malaysia, 59100
Hospital Sultanah Nur Zahirah Recruiting
Kuala Trengganu, Malaysia, 20400
Hospital Tengku Ampuan Afzan Recruiting
Kuantan, Malaysia, 25100
Hospital Umum Sarawak Recruiting
Kuching, Sarawak, Malaysia, 93586
Hospital Kulim Recruiting
Kulim, Kedah, Malaysia, 9000
Hospital Melaka Recruiting
Melaka, Malaysia, 75400
Hospital Pakar Sultanah Fatimah Recruiting
Muar, Malaysia, 84000
Hospital Selayang Recruiting
Selangor, Malaysia, 68100
Hospital Tuanku Ja'afar Recruiting
Seremban, Negeri Sembilan, Malaysia, 70300
Pusat Perubatan UiTM Jalan Hospital Recruiting
Sungai Buloh, Malaysia, 47000
Hospital Sultan Abdul Halim Recruiting
Sungai Petani, Malaysia, 8000
Hospital Taiping Recruiting
Taiping, Perak, Malaysia, 34000
United Kingdom
Antrim Area Hospital Recruiting
Antrim, United Kingdom, BT41 2RL
Ulster Hospital Recruiting
Belfast, United Kingdom, BT16 1RH
Belfast City Hospital Recruiting
Belfast, United Kingdom, BT9 7AB
Queen Elizabeth Hospital Recruiting
Birmingham, United Kingdom, B15 2TH
Royal Sussex County Hospital Recruiting
Brighton, United Kingdom, BN2 5BE
Southmead Hospital Recruiting
Bristol, United Kingdom, BS10 5NB
West Suffolk Hospital Recruiting
Bury St Edmunds, United Kingdom, IP33 2QZ
Kent & Canterbury Hospital, Oncology Department, Canterbury Recruiting
Canterbury, United Kingdom, CT1 3NG
University Hospital of Wales Recruiting
Cardiff, United Kingdom, CF14 4XW
St Helier Hospital Recruiting
Carshalton, United Kingdom, SM5 1AA
Cheltenham General Hospital Recruiting
Cheltenham, United Kingdom, GL53 7AN
Darent Valley Hospital, Chemotherapy Unit Recruiting
Dartford, United Kingdom, DA2 8DA
Royal Derby Hospital Recruiting
Derby, United Kingdom, DE22 3NE
Dorset County Hospital Recruiting
Dorchester, United Kingdom, DT1 2JY
Ninewells Hospital & Medical School Recruiting
Dundee, United Kingdom, DD1 9SY
Royal Infirmary of Edinburgh Recruiting
Edinburgh, United Kingdom, EH16 4SA
Royal Devon and Exeter Hospital Recruiting
Exeter, United Kingdom, EX2 5DW
Queen Elizabeth University Hospital Recruiting
Glasgow, United Kingdom, G51 4TF
Gloucestershire Royal Hospital Recruiting
Gloucester, United Kingdom, GL1 3NN
Ipswich Hospital Recruiting
Ipswich, United Kingdom, IP4 5PD
Victoria Hospital Recruiting
Kirkcaldy, United Kingdom, KY2 5AH
St James's University Hospital Recruiting
Leeds, United Kingdom, LS9 7TF
Aintree University Hospital Recruiting
Liverpool, United Kingdom, L9 7AL
Altnagelvin Area Hospital Recruiting
Londonderry, United Kingdom, BT47 6SB
Royal London Hospital Recruiting
London, United Kingdom, E1 1BB
Royal Free Hospital Recruiting
London, United Kingdom, NW3 2QG
King's College Hospital Recruiting
London, United Kingdom, SE5 9RS
St George's Hospital Recruiting
London, United Kingdom, SW17 0QT
Hammersmith Hospital Recruiting
London, United Kingdom, W12 0HS
Daisy Hill Hospital Recruiting
Newry, United Kingdom, BT35 8DR
Norfolk and Norwich University Hospital Recruiting
Norwich, United Kingdom, NR4 7UY
Nottingham City Hospital Recruiting
Nottingham, United Kingdom, NG5 1PB
Churchill Hospital Recruiting
Oxford, United Kingdom, OX3 7LE
St Bartholomew's Medical Centre (OxFed) Recruiting
Oxford, United Kingdom, OX3 9RF
Derriford Hospital Recruiting
Plymouth, United Kingdom, PL6 5FP
Wessex Kidney Centre Recruiting
Portsmouth, United Kingdom, PO6 3LY
Royal Berkshire Hospital Recruiting
Reading, United Kingdom, RG1 5AN
Salford Royal Hospital Recruiting
Salford, United Kingdom, M6 8HD
Northern General Hospital Recruiting
Sheffield, United Kingdom, S5 7AU
University Hospitals of North Midlands Recruiting
Stoke-on-Trent, United Kingdom, ST4 6QG
Princess Royal Hospital Recruiting
Telford, United Kingdom, TF1 6TF
Royal Cornwall Hospital Recruiting
Truro, United Kingdom, TR1 3LQ
Sponsors and Collaborators
Boehringer Ingelheim
Medical Research Council Population Health Research Unit, CTSU, University of Oxford (academic lead)
Eli Lilly and Company

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03594110     History of Changes
Other Study ID Numbers: 1245-0137
2017-002971-24 ( EudraCT Number )
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https:// trials.boehringer‐ingelheim.com/trial_results/ clinical_submission_documents.html 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 http://trials.boehringeringelheim. com/ 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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.
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'.
URL: https://trials.boehringer‐ingelheim.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Empagliflozin
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs