QPI-1002 Phase 3 for Prevention of Major Adverse Kidney Events (MAKE) in Subjects at High Risk for AKI Following Cardiac Surgery
- Registration Number
- NCT03510897
- Lead Sponsor
- Quark Pharmaceuticals
- Brief Summary
This trial is designed to evaluate QPI-1002 versus placebo for the prevention of Major Adverse Kidney Events (MAKE) in subjects at high risk for acute kidney injury following cardiac surgery. Half of the participants will receive QPI-1002 while the other half will receive placebo.
- Detailed Description
This is a randomized, double-blind, placebo-controlled, Phase 3 trial to evaluate QPI-1002 versus placebo for the prevention of Major Adverse Kidney Events in subjects at high risk for acute kidney injury following cardiac surgery. Subjects will be dosed with active drug or placebo after the completion of cardiovascular surgery.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1043
-
Male or female, age ≥ 18 years old
-
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
Key
- Emergent surgeries, including aortic dissection, and major congenital heart defects
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo isotonic saline QPI-1002 teprasiran QPI-1002 Injection, Single dose
- Primary Outcome Measures
Name Time Method Proportion of subjects through day 90 who develop major adverse kidney events Baseline through day 90
- Secondary Outcome Measures
Name Time Method Proportion of subjects who die or initiate dialysis through day 90 Baseline through day 90 Proportion of subjects developing AKI overall by modified AKIN criteria within 5 days post-surgery Baseline through day 5 Renal function as estimated by glomerular filtration rate Baseline through Day 90
Trial Locations
- Locations (104)
University of Kentucky Healthcare
🇺🇸Lexington, Kentucky, United States
River City Clinical Research
🇺🇸Jacksonville, Florida, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
The Prince Charles Hospital
🇦🇺Chermside, Qeensland, Australia
Klinikum der Friedrich-Schiller-Universitat Jena
🇩🇪Jena, Deutschland, Germany
Hospital Universitario de la Princesa
🇪🇸Madrid, Spain
London Health Sciences Center, University Hospital
🇨🇦London, Ontario, Canada
Columbia University Medical Center
🇺🇸New York, New York, United States
Institut klinicke a experimenalni mediciny, Klinika kardiovaskularni chirurgie
🇨🇿Praha 4, Czechia
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
CHU Besancon-Service de Chirurgie Thoracique et Cardiovasculaire
🇫🇷Besançon, France
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
🇩🇪Mainz, Germany
Universitats-Herzzentrum Freiburg-Bad Krozingen
🇩🇪Bad Krozingen, Germany
Auckland City Hospital
🇳🇿Auckland, New Zealand
Hospital Universitario Reina Sofia
🇪🇸Córdoba, Cordoba, Spain
Hamilton General Hospital
🇨🇦Hamilton, Ontario, Canada
Guy's and St Thomas Hospital
🇬🇧London, United Kingdom
Hopitaux Universitaires de Strasbourg - Service de Chirurgie Cardiovasculaire
🇫🇷Strasbourg Cedex, France
Universitatklinicum Essen Westdeutsches Herzzentrum Essen
🇩🇪Essen, Germany
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Spain
The Townsville Hospital
🇦🇺Douglas, Queensland, Australia
RHON-KLINIKUM Campus Bad Neustadt
🇩🇪Bad Neustadt An Der Saale, Germany
University of Ottawa Heart Institute
🇨🇦Ottawa, Ontario, Canada
Fakultni nemocnice Motol a 2. LF UK, Klinika kariovaskularni chirurgie 2. LF. UK
🇨🇿Praha 5, Czechia
Fakulni nemocnice Hradec Kralove, Kardiochirurgicka klinika
🇨🇿Hradec Králové, Czechia
Universitatsklinikum Heidelberg und Medizinische Fakultat
🇩🇪Heidelberg, Germany
Universitasklinikum Giessen und Marburg GmbH
🇩🇪Geißen, Hesse, Germany
CHU Bordeaux
🇫🇷Pessac Cedex, France
Hospital Robert Debre
🇫🇷Reims, France
Hospital Clinic Universitario de Valencia
🇪🇸Valencia, Spain
Herzchirurgische Klinik und Poliklinik
🇩🇪München, Germany
Hospital Universitario de Cruces
🇪🇸Barakaldo, Spain
Deutsches Herzzentrum Munchen
🇩🇪München, Bavaria, Germany
Keck Hospital of USC
🇺🇸Los Angeles, California, United States
Cedar-Sinai Heart Institute
🇺🇸Los Angeles, California, United States
Mission Hospital, Inc.
🇺🇸Asheville, North Carolina, United States
Indiana/ Ohio Heart, a division of Luthern Medical Group, LLC
🇺🇸Fort Wayne, Indiana, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
St. Boniface Hospital
🇨🇦Winnipeg, Manitoba, Canada
Ronald Regan UCLA Medical Center
🇺🇸Los Angeles, California, United States
Northwestern University
🇺🇸Evanston, Illinois, United States
MidMichigan Medical Center Midland
🇺🇸Midland, Michigan, United States
Nebraska Heart Hospital
🇺🇸Lincoln, Nebraska, United States
Emory Saint Joseph's Hospital
🇺🇸Atlanta, Georgia, United States
Cardiac & Vascular Research Center of Northern Michigan
🇺🇸Petoskey, Michigan, United States
Bryan Heart
🇺🇸Lincoln, Nebraska, United States
East Carolina Heart Institute at East Carolina University
🇺🇸Greenville, North Carolina, United States
Baylor Jack and Jane Hamilton Heart and Vascular Hospital - Soltero Cardiovasular
🇺🇸Dallas, Texas, United States
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Princess Alexandra Hospital
🇦🇺Woolloongabba, Qeensland, Australia
Kepler Universitatsklinikum GmbH
🇦🇹Linz, Upper Austria, Austria
Monash Medical Centre
🇦🇺Clayton, Victoria, Australia
Royal Jubilee Hospital (Victoria Island Health Authority)
🇨🇦Victoria, British Columbia, Canada
CHU - Grenoble Alpes
🇫🇷Grenoble Cedex 9, France
Universitatsklinikum Schleswig-Holstein, Campus Lubeck
🇩🇪Lubeck, Germany
Wellington Regional Hospital
🇳🇿Wellington, New Zealand
Foothills Medical Centre, Libin Cardiovascular Institute of Alberta, University of Calgary
🇨🇦Calgary, Alberta, Canada
St. Vincent's Hospital Melbourne
🇦🇺Fitzroy, Victoria, Australia
Hospital Clinico Universitario de Santiago-CHUS
🇪🇸Santiago De Compostela, A Coruña, Spain
Hospital Universitari de Bellvitge
🇪🇸L'Hospitalet De Llobregat, Barcelona, Spain
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Medizinische Universitat Innsbruck
🇦🇹Innsbruck, Tyrol, Austria
Medizinische Universitat Wien
🇦🇹Wien, Austria
Saint Barnabas Medical Center
🇺🇸Livingston, New Jersey, United States
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
McGill University Health Center - Royal Victoria Hospital
🇨🇦Montréal, Quebec, Canada
Institut Universitaire de cardiologie et de pneomologie de Quebec, Universite Laval
🇨🇦Québec, Quebec, Canada
Austin Hospital
🇦🇺Heidelberg, Victoria, Australia
Horizon Health Network, Saint John Regional Hospital
🇨🇦Saint John, New Brunswick, Canada
University Hospital Leuven, Campus Gasthuisberg
🇧🇪Leuven, Belgium
Charite-Universitatsmedizin Berlin
🇩🇪Berlin, Brandenburg, Germany
University of Alberta Hospital / Mazankowski Alberta Heart Institute
🇨🇦Edmonton, Alberta, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
🇨🇦Montreal, Quebec, Canada
Krankenhaus der Barmherzigen Bruder Trier
🇩🇪Trier, Rhineland-Palatinate, Germany
Herzzentrum Leipzig
🇩🇪Leipzig, Saxony, Germany
Royal Papworth Hospital NHS Foundation Trust
🇬🇧Cambridge, Cambridgeshire, United Kingdom
Universitatsklinikum Frankfurt am Main
🇩🇪Frankfurt am main, Hesse, Germany
Herz-Und Gefasszentrum Bad Bevensen
🇩🇪Bad Bevensen, Lower Saxony, Germany
Chu Pontchaillou Rennes
🇫🇷Rennes, France
CHU Toulouse - Hospital Rangueil-Service de Chirurgie Cadriovasculaire
🇫🇷Toulouse, France
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Universitatsklinikum Bonn
🇩🇪Bonn, Germany
Universitatsklinikum "Carl Gustav Carus" der Technischen Universitat Dresden Klinik fur Herzchirurgle
🇩🇪Dresden, Germany
Flinders Medical Centre
🇦🇺Bedford Park, South Australia, Australia
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
University Hospital
🇺🇸Madison, Wisconsin, United States
Deutsches Herzzentrum Berlin
🇩🇪Berlin, Germany
Waikato Hospital
🇳🇿Hamilton, New Zealand
University of Alabama at Birmingham Hospital
🇺🇸Birmingham, Alabama, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Indiana University Health-Methodist Hospital
🇺🇸Indianapolis, Indiana, United States
University of Louisville Physicians (ULP)
🇺🇸Louisville, Kentucky, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
University of Utah Health
🇺🇸Salt Lake City, Utah, United States
Saint Luke's Hospital of Kansas City
🇺🇸Kansas City, Missouri, United States
Duke University Hospital Medical Center
🇺🇸Durham, North Carolina, United States
Wake Forest Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Aurora St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Virginia Commonwealth University Medical Center
🇺🇸Richmond, Virginia, United States
Complejo Hospitalario de Navarra
🇪🇸Pamplona, Navarra, Spain
Hospital Universitario Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain