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

Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03510897
• Other study ID #: QRK309
• Status: Terminated
• Phase: Phase 3
• Start date: June 29, 2018
• Est. completion date: April 12, 2021

Study information

• Verified date: July 2021
• Source: Quark Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 1043
• Est. completion date: April 12, 2021
• Est. primary completion date: October 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

Drug:
• teprasiran
IV injection
• Placebo
isotonic saline

Locations

Country	Name	City	State
Australia	Flinders Medical Centre	Bedford Park	South Australia
Australia	The Prince Charles Hospital	Chermside	Qeensland
Australia	Monash Medical Centre	Clayton	Victoria
Australia	The Townsville Hospital	Douglas	Queensland
Australia	St. Vincent's Hospital Melbourne	Fitzroy	Victoria
Australia	Austin Hospital	Heidelberg	Victoria
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	Westmead Hospital	Westmead	New South Wales
Australia	Princess Alexandra Hospital	Woolloongabba	Qeensland
Austria	Medizinische Universitat Innsbruck	Innsbruck	Tyrol
Austria	Kepler Universitatsklinikum GmbH	Linz	Upper Austria
Austria	Medizinische Universitat Wien	Wien
Belgium	University Hospital Leuven, Campus Gasthuisberg	Leuven
Canada	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	Hamilton General Hospital	Hamilton	Ontario
Canada	London Health Sciences Center, University Hospital	London	Ontario
Canada	Centre Hospitalier de l'Universite de Montreal (CHUM)	Montreal	Quebec
Canada	McGill University Health Center - Royal Victoria Hospital	Montréal	Quebec
Canada	University of Ottawa Heart Institute	Ottawa	Ontario
Canada	Institut Universitaire de cardiologie et de pneomologie de Quebec, Universite Laval	Québec	Quebec
Canada	Horizon Health Network, Saint John Regional Hospital	Saint John	New Brunswick
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Royal Jubilee Hospital (Victoria Island Health Authority)	Victoria	British Columbia
Canada	St. Boniface Hospital	Winnipeg	Manitoba
Czechia	Fakulni nemocnice Hradec Kralove, Kardiochirurgicka klinika	Hradec Králové
Czechia	Institut klinicke a experimenalni mediciny, Klinika kardiovaskularni chirurgie	Praha 4
Czechia	Fakultni nemocnice Motol a 2. LF UK, Klinika kariovaskularni chirurgie 2. LF. UK	Praha 5
France	CHU Besancon-Service de Chirurgie Thoracique et Cardiovasculaire	Besançon
France	CHU - Grenoble Alpes	Grenoble Cedex 9
France	CHU Bordeaux	Pessac Cedex
France	Hospital Robert Debre	Reims
France	Chu Pontchaillou Rennes	Rennes
France	Hopitaux Universitaires de Strasbourg - Service de Chirurgie Cardiovasculaire	Strasbourg Cedex
France	CHU Toulouse - Hospital Rangueil-Service de Chirurgie Cadriovasculaire	Toulouse
Germany	Herz-Und Gefasszentrum Bad Bevensen	Bad Bevensen	Lower Saxony
Germany	Universitats-Herzzentrum Freiburg-Bad Krozingen	Bad Krozingen
Germany	RHON-KLINIKUM Campus Bad Neustadt	Bad Neustadt An Der Saale
Germany	Charite-Universitatsmedizin Berlin	Berlin	Brandenburg
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 Frankfurt am Main	Frankfurt am main	Hesse
Germany	Universitasklinikum Giessen und Marburg GmbH	Geißen	Hesse
Germany	Universitatsklinikum Heidelberg und Medizinische Fakultat	Heidelberg
Germany	Klinikum der Friedrich-Schiller-Universitat Jena	Jena	Deutschland
Germany	Herzzentrum Leipzig	Leipzig	Saxony
Germany	Universitatsklinikum Schleswig-Holstein, Campus Lubeck	Lubeck
Germany	Universitatsmedizin der Johannes Gutenberg-Universitat Mainz	Mainz
Germany	Deutsches Herzzentrum Munchen	München	Bavaria
Germany	Herzchirurgische Klinik und Poliklinik	München
Germany	Krankenhaus der Barmherzigen Bruder Trier	Trier	Rhineland-Palatinate
New Zealand	Auckland City Hospital	Auckland
New Zealand	Waikato Hospital	Hamilton
New Zealand	Wellington Regional Hospital	Wellington
Spain	Hospital Universitario Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Universitario de Cruces	Barakaldo
Spain	Hospital Universitario Reina Sofia	Córdoba	Cordoba
Spain	Hospital Universitari de Bellvitge	L'Hospitalet De Llobregat	Barcelona
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Universitario de la Princesa	Madrid
Spain	Hospital Universitario Central de Asturias	Oviedo
Spain	Complejo Hospitalario de Navarra	Pamplona	Navarra
Spain	Hospital Clinico Universitario de Santiago-CHUS	Santiago De Compostela	A Coruña
Spain	Hospital Clinic Universitario de Valencia	Valencia
United Kingdom	Royal Papworth Hospital NHS Foundation Trust	Cambridge	Cambridgeshire
United Kingdom	Guy's and St Thomas Hospital	London
United States	Mission Hospital, Inc.	Asheville	North Carolina
United States	Emory Saint Joseph's Hospital	Atlanta	Georgia
United States	University of Alabama at Birmingham Hospital	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
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	Duke University Hospital Medical Center	Durham	North Carolina
United States	Northwestern University	Evanston	Illinois
United States	Indiana/ Ohio Heart, a division of Luthern Medical Group, LLC	Fort Wayne	Indiana
United States	East Carolina Heart Institute at East Carolina University	Greenville	North Carolina
United States	Indiana University Health-Methodist Hospital	Indianapolis	Indiana
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	River City Clinical Research	Jacksonville	Florida
United States	Saint Luke's Hospital of Kansas City	Kansas City	Missouri
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	University of Kentucky Healthcare	Lexington	Kentucky
United States	Bryan Heart	Lincoln	Nebraska
United States	Nebraska Heart Hospital	Lincoln	Nebraska
United States	Saint Barnabas Medical Center	Livingston	New Jersey
United States	Cedar-Sinai Heart Institute	Los Angeles	California
United States	Keck Hospital of USC	Los Angeles	California
United States	Ronald Regan UCLA Medical Center	Los Angeles	California
United States	University of Louisville Physicians (ULP)	Louisville	Kentucky
United States	University Hospital	Madison	Wisconsin
United States	MidMichigan Medical Center Midland	Midland	Michigan
United States	Aurora St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Columbia University Medical Center	New York	New York
United States	Cardiac & Vascular Research Center of Northern Michigan	Petoskey	Michigan
United States	Oregon Health and Science University	Portland	Oregon
United States	Virginia Commonwealth University Medical Center	Richmond	Virginia
United States	University of Utah Health	Salt Lake City	Utah
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Quark Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Czechia,  France,  Germany,  New Zealand,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects through day 90 who develop major adverse kidney events		Baseline through day 90
Secondary	Proportion of subjects developing AKI overall by modified AKIN criteria within 5 days post-surgery		Baseline through day 5
Secondary	Renal function as estimated by glomerular filtration rate		Baseline through Day 90
Secondary	Proportion of subjects who die or initiate dialysis through day 90		Baseline through day 90