QPI-1002 Phase 3 for Prevention of Major Adverse Kidney Events (MAKE) in Subjects at High Risk for AKI Following Cardiac Surgery
Launched by QUARK PHARMACEUTICALS · Apr 26, 2018
Trial Information
Current as of May 22, 2025
Terminated
Keywords
ClinConnect Summary
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.
Gender
ALL
Eligibility criteria
- 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
About Quark Pharmaceuticals
Quark Pharmaceuticals is a pioneering biotechnology company focused on the discovery and development of innovative RNA-based therapeutics for a range of diseases, including neurodegenerative disorders, cancer, and ocular diseases. With a commitment to advancing precision medicine, Quark leverages its proprietary technologies to design and optimize RNA interference (RNAi) therapies that target specific molecular pathways. The company is dedicated to conducting rigorous clinical trials to evaluate the safety and efficacy of its drug candidates, aiming to transform patient care through groundbreaking therapeutic solutions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Boston, Massachusetts, United States
New York, New York, United States
Charleston, South Carolina, United States
Charlottesville, Virginia, United States
Westmead, New South Wales, Australia
Heidelberg, Victoria, Australia
Lebanon, New Hampshire, United States
Livingston, New Jersey, United States
Portland, Oregon, United States
Dallas, Texas, United States
New Haven, Connecticut, United States
Jacksonville, Florida, United States
Ottawa, Ontario, Canada
Winston Salem, North Carolina, United States
Madrid, , Spain
New Haven, Connecticut, United States
Melbourne, Victoria, Australia
Bedford Park, South Australia, Australia
Atlanta, Georgia, United States
Kansas City, Missouri, United States
Madrid, , Spain
Toronto, Ontario, Canada
Richmond, Virginia, United States
Clayton, Victoria, Australia
Petoskey, Michigan, United States
Badalona, Barcelona, Spain
Pamplona, Navarra, Spain
Lincoln, Nebraska, United States
Hamilton, , New Zealand
Milwaukee, Wisconsin, United States
Hamilton, Ontario, Canada
Auckland, , New Zealand
Madrid, , Spain
Fitzroy, Victoria, Australia
Birmingham, Alabama, United States
Berlin, , Germany
Evanston, Illinois, United States
Madison, Wisconsin, United States
Jacksonville, Florida, United States
Douglas, Queensland, Australia
Cleveland, Ohio, United States
Los Angeles, California, United States
L'hospitalet De Llobregat, Barcelona, Spain
Greenville, North Carolina, United States
Oviedo, , Spain
Asheville, North Carolina, United States
Charlottesville, Virginia, United States
Los Angeles, California, United States
Winnipeg, Manitoba, Canada
Wien, , Austria
Indianapolis, Indiana, United States
Leuven, , Belgium
Durham, North Carolina, United States
Lincoln, Nebraska, United States
Barakaldo, , Spain
Midland, Michigan, United States
Bonn, , Germany
Wellington, , New Zealand
Los Angeles, California, United States
Salt Lake City, Utah, United States
Lexington, Kentucky, United States
London, , United Kingdom
Innsbruck, Tyrol, Austria
Charleston, South Carolina, United States
Fort Wayne, Indiana, United States
Louisville, Kentucky, United States
Dallas, Texas, United States
Chermside, Qeensland, Australia
Woolloongabba, Qeensland, Australia
Linz, Upper Austria, Austria
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Victoria, British Columbia, Canada
Saint John, New Brunswick, Canada
London, Ontario, Canada
Montreal, Quebec, Canada
Montréal, Quebec, Canada
Québec, Quebec, Canada
Hradec Králové, , Czechia
Praha 4, , Czechia
Praha 5, , Czechia
Besançon, , France
Grenoble Cedex 9, , France
Pessac Cedex, , France
Reims, , France
Rennes, , France
Strasbourg Cedex, , France
Toulouse, , France
München, Bavaria, Germany
Berlin, Brandenburg, Germany
Jena, Deutschland, Germany
Frankfurt Am Main, Hesse, Germany
Geißen, Hesse, Germany
Bad Bevensen, Lower Saxony, Germany
Trier, Rhineland Palatinate, Germany
Leipzig, Saxony, Germany
Bad Krozingen, , Germany
Bad Neustadt An Der Saale, , Germany
Dresden, , Germany
Essen, , Germany
Heidelberg, , Germany
Lubeck, , Germany
Mainz, , Germany
München, , Germany
Santiago De Compostela, A Coruña, Spain
Córdoba, Cordoba, Spain
Valencia, , Spain
Cambridge, Cambridgeshire, United Kingdom
Patients applied
Trial Officials
Nitsan Halevy, MD
Study Director
Quark Pharmaceuticals
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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