QPI-1002 Phase 3 for Prevention of Major Adverse Kidney Events (MAKE) in Subjects at High Risk for AKI Following Cardiac Surgery
NCT ID: NCT03510897
Last Updated: 2021-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
1043 participants
INTERVENTIONAL
2018-06-29
2021-04-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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QPI-1002
QPI-1002 Injection, Single dose
teprasiran
IV injection
Placebo
isotonic saline
Placebo
isotonic saline
Interventions
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teprasiran
IV injection
Placebo
isotonic saline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At risk for AKI following cardiac surgery on the basis of at least one of the following pre-operatively assessed risk factors:
* Reduced renal function
* Diabetes with ongoing insulin treatment
* Albuminuria
* Undergoes non-emergent open chest cavity cardiovascular surgeries, with use of cardiopulmonary bypass (CPB), with or without hypothermic circulatory arrest
Exclusion Criteria
* Undergoes cardiac surgery off CPB for subjects ≥45 years old. (Cardiac surgery off CPB for subjects \<45 years old is allowed.)
* Perioperative or post cardiac surgery, an left ventricular assist device (LVAD) is inserted or anticipated
18 Years
ALL
No
Sponsors
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Quark Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Nitsan Halevy, MD
Role: STUDY_DIRECTOR
Quark Pharmaceuticals
Locations
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University of Alabama at Birmingham Hospital
Birmingham, Alabama, United States
Keck Hospital of USC
Los Angeles, California, United States
Cedar-Sinai Heart Institute
Los Angeles, California, United States
Ronald Regan UCLA Medical Center
Los Angeles, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
River City Clinical Research
Jacksonville, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States
Northwestern University
Evanston, Illinois, United States
Indiana/ Ohio Heart, a division of Luthern Medical Group, LLC
Fort Wayne, Indiana, United States
Indiana University Health-Methodist Hospital
Indianapolis, Indiana, United States
University of Kentucky Healthcare
Lexington, Kentucky, United States
University of Louisville Physicians (ULP)
Louisville, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
MidMichigan Medical Center Midland
Midland, Michigan, United States
Cardiac & Vascular Research Center of Northern Michigan
Petoskey, Michigan, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Bryan Heart
Lincoln, Nebraska, United States
Nebraska Heart Hospital
Lincoln, Nebraska, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Saint Barnabas Medical Center
Livingston, New Jersey, United States
Columbia University Medical Center
New York, New York, United States
Mission Hospital, Inc.
Asheville, North Carolina, United States
Duke University Hospital Medical Center
Durham, North Carolina, United States
East Carolina Heart Institute at East Carolina University
Greenville, North Carolina, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Baylor Jack and Jane Hamilton Heart and Vascular Hospital - Soltero Cardiovasular
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
University of Utah Health
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States
University Hospital
Madison, Wisconsin, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Westmead Hospital
Westmead, New South Wales, Australia
The Prince Charles Hospital
Chermside, Qeensland, Australia
Princess Alexandra Hospital
Woolloongabba, Qeensland, Australia
The Townsville Hospital
Douglas, Queensland, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Monash Medical Centre
Clayton, Victoria, Australia
St. Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia
Austin Hospital
Heidelberg, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Medizinische Universitat Innsbruck
Innsbruck, Tyrol, Austria
Kepler Universitatsklinikum GmbH
Linz, Upper Austria, Austria
Medizinische Universitat Wien
Vienna, , Austria
University Hospital Leuven, Campus Gasthuisberg
Leuven, , Belgium
Foothills Medical Centre, Libin Cardiovascular Institute of Alberta, University of Calgary
Calgary, Alberta, Canada
University of Alberta Hospital / Mazankowski Alberta Heart Institute
Edmonton, Alberta, Canada
Royal Jubilee Hospital (Victoria Island Health Authority)
Victoria, British Columbia, Canada
St. Boniface Hospital
Winnipeg, Manitoba, Canada
Horizon Health Network, Saint John Regional Hospital
Saint John, New Brunswick, Canada
Hamilton General Hospital
Hamilton, Ontario, Canada
London Health Sciences Center, University Hospital
London, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, Canada
McGill University Health Center - Royal Victoria Hospital
Montreal, Quebec, Canada
Institut Universitaire de cardiologie et de pneomologie de Quebec, Universite Laval
Québec, Quebec, Canada
Fakulni nemocnice Hradec Kralove, Kardiochirurgicka klinika
Hradec Králové, , Czechia
Institut klinicke a experimenalni mediciny, Klinika kardiovaskularni chirurgie
Prague, , Czechia
Fakultni nemocnice Motol a 2. LF UK, Klinika kariovaskularni chirurgie 2. LF. UK
Prague, , Czechia
CHU Besancon-Service de Chirurgie Thoracique et Cardiovasculaire
Besançon, , France
CHU - Grenoble Alpes
Grenoble, , France
CHU Bordeaux
Pessac, , France
Hospital Robert Debre
Reims, , France
Chu Pontchaillou Rennes
Rennes, , France
Hopitaux Universitaires de Strasbourg - Service de Chirurgie Cardiovasculaire
Strasbourg, , France
CHU Toulouse - Hospital Rangueil-Service de Chirurgie Cadriovasculaire
Toulouse, , France
Deutsches Herzzentrum Munchen
München, Bavaria, Germany
Charite-Universitatsmedizin Berlin
Berlin, Brandenburg, Germany
Klinikum der Friedrich-Schiller-Universitat Jena
Jena, Deutschland, Germany
Universitatsklinikum Frankfurt am Main
Frankfurt am Main, Hesse, Germany
Universitasklinikum Giessen und Marburg GmbH
Geißen, Hesse, Germany
Herz-Und Gefasszentrum Bad Bevensen
Bad Bevensen, Lower Saxony, Germany
Krankenhaus der Barmherzigen Bruder Trier
Trier, Rhineland-Palatinate, Germany
Herzzentrum Leipzig
Leipzig, Saxony, Germany
Universitats-Herzzentrum Freiburg-Bad Krozingen
Bad Krozingen, , Germany
RHON-KLINIKUM Campus Bad Neustadt
Bad Neustadt an der Saale, , Germany
Deutsches Herzzentrum Berlin
Berlin, , Germany
Universitatsklinikum Bonn
Bonn, , Germany
Universitatsklinikum "Carl Gustav Carus" der Technischen Universitat Dresden Klinik fur Herzchirurgle
Dresden, , Germany
Universitatklinicum Essen Westdeutsches Herzzentrum Essen
Essen, , Germany
Universitatsklinikum Heidelberg und Medizinische Fakultat
Heidelberg, , Germany
Universitatsklinikum Schleswig-Holstein, Campus Lubeck
Lübeck, , Germany
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
Mainz, , Germany
Herzchirurgische Klinik und Poliklinik
München, , Germany
Auckland City Hospital
Auckland, , New Zealand
Waikato Hospital
Hamilton, , New Zealand
Wellington Regional Hospital
Wellington, , New Zealand
Hospital Clinico Universitario de Santiago-CHUS
Santiago de Compostela, A Coruña, Spain
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Reina Sofia
Córdoba, Cordoba, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, Spain
Hospital Universitario de Cruces
Barakaldo, , Spain
Hospital Universitario de la Princesa
Madrid, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Universitario Central de Asturias
Oviedo, , Spain
Hospital Clinic Universitario de Valencia
Valencia, , Spain
Royal Papworth Hospital NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom
Guy's and St Thomas Hospital
London, , United Kingdom
Countries
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References
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Scurt FG, Bose K, Mertens PR, Chatzikyrkou C, Herzog C. Cardiac Surgery-Associated Acute Kidney Injury. Kidney360. 2024 Jun 1;5(6):909-926. doi: 10.34067/KID.0000000000000466. Epub 2024 May 1.
Thielmann M, Corteville D, Szabo G, Swaminathan M, Lamy A, Lehner LJ, Brown CD, Noiseux N, Atta MG, Squiers EC, Erlich S, Rothenstein D, Molitoris B, Mazer CD. Teprasiran, a Small Interfering RNA, for the Prevention of Acute Kidney Injury in High-Risk Patients Undergoing Cardiac Surgery: A Randomized Clinical Study. Circulation. 2021 Oct 5;144(14):1133-1144. doi: 10.1161/CIRCULATIONAHA.120.053029. Epub 2021 Sep 3.
Hinze C, Karaiskos N, Boltengagen A, Walentin K, Redo K, Himmerkus N, Bleich M, Potter SS, Potter AS, Eckardt KU, Kocks C, Rajewsky N, Schmidt-Ott KM. Kidney Single-cell Transcriptomes Predict Spatial Corticomedullary Gene Expression and Tissue Osmolality Gradients. J Am Soc Nephrol. 2021 Feb;32(2):291-306. doi: 10.1681/ASN.2020070930. Epub 2020 Nov 25.
Other Identifiers
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QRK309
Identifier Type: -
Identifier Source: org_study_id
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