QPI-1002 Phase 3 for Prevention of Major Adverse Kidney Events (MAKE) in Subjects at High Risk for AKI Following Cardiac Surgery

July 12, 2021 updated by: Quark Pharmaceuticals

A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of QPI-1002 for the Prevention of Major Adverse Kidney Events (MAKE) in Subjects at High Risk for Acute Kidney Injury (AKI) Following Cardiac Surgery

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1043

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
    • Qeensland
      • Chermside, Qeensland, Australia, 4032
        • The Prince Charles Hospital
      • Woolloongabba, Qeensland, Australia, 4102
        • Princess Alexandra Hospital
    • Queensland
      • Douglas, Queensland, Australia, 4814
        • The Townsville Hospital
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Flinders Medical Centre
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Centre
      • Fitzroy, Victoria, Australia, 3065
        • St. Vincent's Hospital Melbourne
      • Heidelberg, Victoria, Australia, 3084
        • Austin Hospital
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
  • Austria
      • Wien, Austria, 1090
        • Medizinische Universität Wien
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Medizinische Universität Innsbruck
    • Upper Austria
      • Linz, Upper Austria, Austria, 4021
        • Kepler Universitätsklinikum GmbH
  • Belgium
      • Leuven, Belgium, 3000
        • University Hospital Leuven, Campus Gasthuisberg
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Foothills Medical Centre, Libin Cardiovascular Institute of Alberta, University of Calgary
      • Edmonton, Alberta, Canada, TG6 2B7
        • University of Alberta Hospital / Mazankowski Alberta Heart Institute
    • British Columbia
      • Victoria, British Columbia, Canada, V8R 1J8
        • Royal Jubilee Hospital (Victoria Island Health Authority)
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H2A6
        • St. Boniface Hospital
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L4L2
        • Horizon Health Network, Saint John Regional Hospital
    • Ontario
      • Hamilton, Ontario, Canada, L8L2X2
        • Hamilton General Hospital
      • London, Ontario, Canada, N6A5A5
        • London Health Sciences Center, University Hospital
      • Ottawa, Ontario, Canada, K1Y4W7
        • University of Ottawa Heart Institute
      • Toronto, Ontario, Canada, M5B1W8
        • St. Michael's Hospital
    • Quebec
      • Montreal, Quebec, Canada, H2X0C1
        • Centre hospitalier de l'Université de Montréal (CHUM)
      • Montréal, Quebec, Canada, H4A3J1
        • McGill University Health Center - Royal Victoria Hospital
      • Québec, Quebec, Canada, G1V4G5
        • Institut Universitaire de cardiologie et de pneomologie de Quebec, Universite Laval
  • Czechia
      • Hradec Králové, Czechia, 500 05
        • Fakulni nemocnice Hradec Kralove, Kardiochirurgicka klinika
      • Praha 4, Czechia, 140 21
        • Institut klinicke a experimenalni mediciny, Klinika kardiovaskularni chirurgie
      • Praha 5, Czechia, 15006
        • Fakultni nemocnice Motol a 2. LF UK, Klinika kariovaskularni chirurgie 2. LF. UK
  • France
      • Besançon, France, 25000
        • CHU Besancon-Service de Chirurgie Thoracique et Cardiovasculaire
      • Grenoble Cedex 9, France, 38043
        • CHU - Grenoble Alpes
      • Pessac Cedex, France, 33604
        • CHU Bordeaux
      • Reims, France, 51092
        • Hospital Robert Debre
      • Rennes, France, 35000
        • CHU Pontchaillou Rennes
      • Strasbourg Cedex, France, 67091
        • Hopitaux Universitaires de Strasbourg - Service de Chirurgie Cardiovasculaire
      • Toulouse, France, 31059
        • CHU Toulouse - Hospital Rangueil-Service de Chirurgie Cadriovasculaire
  • Germany
      • Bad Krozingen, Germany, 79189
        • Universitäts-Herzzentrum Freiburg-Bad Krozingen
      • Bad Neustadt An Der Saale, Germany, 97616
        • Rhön-Klinikum Campus Bad Neustadt
      • Berlin, Germany, 13353
        • Deutsches Herzzentrum Berlin
      • Bonn, Germany, 53127
        • Universitätsklinikum Bonn
      • Dresden, Germany, 01307
        • Universitatsklinikum "Carl Gustav Carus" der Technischen Universitat Dresden Klinik fur Herzchirurgle
      • Essen, Germany, 45122
        • Universitatklinicum Essen Westdeutsches Herzzentrum Essen
      • Heidelberg, Germany, 69120
        • Universitatsklinikum Heidelberg und Medizinische Fakultat
      • Lubeck, Germany, 23538
        • Universitätsklinikum Schleswig-Holstein, Campus Lübeck
      • Mainz, Germany, 55131
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
      • München, Germany, 81377
        • Herzchirurgische Klinik und Poliklinik
    • Bavaria
      • München, Bavaria, Germany, 80636
        • Deutsches Herzzentrum München
    • Brandenburg
      • Berlin, Brandenburg, Germany, 13353
        • Charite-Universitatsmedizin Berlin
    • Deutschland
      • Jena, Deutschland, Germany, 07747
        • Klinikum der Friedrich-Schiller-Universität Jena
    • Hesse
      • Frankfurt am main, Hesse, Germany, 60590
        • Universitätsklinikum Frankfurt am Main
      • Geißen, Hesse, Germany, 35392
        • Universitasklinikum Giessen und Marburg GmbH
    • Lower Saxony
      • Bad Bevensen, Lower Saxony, Germany, 29549
        • Herz-Und Gefasszentrum Bad Bevensen
    • Rhineland-Palatinate
      • Trier, Rhineland-Palatinate, Germany, 54292
        • Krankenhaus der Barmherzigen Brüder Trier
    • Saxony
      • Leipzig, Saxony, Germany, 04289
        • Herzzentrum Leipzig
  • New Zealand
      • Auckland, New Zealand, 1023
        • Auckland City Hospital
      • Hamilton, New Zealand, 3204
        • Waikato Hospital
      • Wellington, New Zealand, 6021
        • Wellington Regional Hospital
  • Spain
      • Barakaldo, Spain, 48903
        • Hospital Universitario de Cruces
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28006
        • Hospital Universitario de La Princesa
      • Oviedo, Spain, 33011
        • Hospital Universitario Central de Asturias
      • Valencia, Spain, 46010
        • Hospital Clinic Universitario de Valencia
    • A Coruña
      • Santiago De Compostela, A Coruña, Spain, 15706
        • Hospital Clínico Universitario de Santiago-CHUS
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitario Germans Trias i Pujol
      • L'Hospitalet De Llobregat, Barcelona, Spain, 08907
        • Hospital Universitari de Bellvitge
    • Cordoba
      • Córdoba, Cordoba, Spain, 14004
        • Hospital Universitario Reina Sofia
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Complejo Hospitalario de Navarra
  • United Kingdom
      • London, United Kingdom, SE1 7EH
        • Guy's and St Thomas Hospital
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 0AY
        • Royal Papworth Hospital NHS Foundation Trust
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham Hospital
    • California
      • Los Angeles, California, United States, 90033
        • Keck Hospital of USC
      • Los Angeles, California, United States, 90095
        • Ronald Regan UCLA Medical Center
      • Los Angeles, California, United States, 90048
        • Cedar-Sinai Heart Institute
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University School Of Medicine
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clinical Research
      • Jacksonville, Florida, United States, 32207
        • River City Clinical Research
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Emory Saint Joseph's Hospital
    • Illinois
      • Evanston, Illinois, United States, 60208
        • Northwestern University
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Indiana/ Ohio Heart, a division of Luthern Medical Group, LLC
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health-Methodist Hospital
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky HealthCare
      • Louisville, Kentucky, United States, 40202
        • University of Louisville Physicians (ULP)
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Midland, Michigan, United States, 48670
        • MidMichigan Medical Center Midland
      • Petoskey, Michigan, United States, 49770
        • Cardiac & Vascular Research Center of Northern Michigan
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint Luke'S Hospital of Kansas City
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Nebraska Heart Hospital
      • Lincoln, Nebraska, United States, 68506
        • Bryan Heart
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Livingston, New Jersey, United States, 07039
        • Saint Barnabas Medical Center
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Mission Hospital, Inc.
      • Durham, North Carolina, United States, 27710
        • Duke University Hospital Medical Center
      • Greenville, North Carolina, United States, 27834
        • East Carolina Heart Institute at East Carolina University
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
      • Dallas, Texas, United States, 75246
        • Baylor Jack and Jane Hamilton Heart and Vascular Hospital - Soltero Cardiovasular
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Health
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University Medical Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University Hospital
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora St. Luke's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • 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 Exclusion Criteria:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: QPI-1002
QPI-1002 Injection, Single dose
Drug: teprasiran
IV injection
Other Names:
  • QPI-1002
Placebo Comparator: Placebo
isotonic saline
Drug: Placebo
isotonic saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects through day 90 who develop major adverse kidney events
Time Frame: Baseline through day 90
Baseline through day 90

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects developing AKI overall by modified AKIN criteria within 5 days post-surgery
Time Frame: Baseline through day 5
Baseline through day 5
Renal function as estimated by glomerular filtration rate
Time Frame: Baseline through Day 90
Baseline through Day 90
Proportion of subjects who die or initiate dialysis through day 90
Time Frame: Baseline through day 90
Baseline through day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Quark Pharmaceuticals

Investigators

  • Study Director: Nitsan Halevy, MD, Quark Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 29, 2018

Primary Completion (Actual)

October 14, 2020

Study Completion (Actual)

April 12, 2021

Study Registration Dates

First Submitted

April 18, 2018

First Submitted That Met QC Criteria

April 26, 2018

First Posted (Actual)

April 27, 2018

Study Record Updates

Last Update Posted (Actual)

July 16, 2021

Last Update Submitted That Met QC Criteria

July 12, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • QRK309

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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