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Cardiac SurgeryPhase 3NCT03510897

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

A Phase 3 study testing teprasiran in people with Cardiac Surgery, run by Quark Pharmaceuticals at 104 sites in 11 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiac Surgery
What is being tested?
teprasiran
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,043 participants
Where
104 sitesin 11 countries
Study dates
29 Jun 2018to 12 Apr 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

104 sites in 11 countries.

104 sites in 11 countries

United States36 sites

  • Mission Hospital, Inc.

    Asheville, North Carolina, 28801

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

  • University of Alabama at Birmingham Hospital

    Birmingham, Alabama, 35294

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • University of Virginia

    Charlottesville, Virginia, 22908

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Baylor Jack and Jane Hamilton Heart and Vascular Hospital - Soltero Cardiovasular

    Dallas, Texas, 75246

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Duke University Hospital Medical Center

    Durham, North Carolina, 27710

  • Northwestern University

    Evanston, Illinois, 60208

  • Indiana/ Ohio Heart, a division of Luthern Medical Group, LLC

    Fort Wayne, Indiana, 46804

  • East Carolina Heart Institute at East Carolina University

    Greenville, North Carolina, 27834

  • Indiana University Health-Methodist Hospital

    Indianapolis, Indiana, 46202

  • River City Clinical Research

    Jacksonville, Florida, 32207

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • University of Kentucky Healthcare

    Lexington, Kentucky, 40536

  • Bryan Heart

    Lincoln, Nebraska, 68506

  • Nebraska Heart Hospital

    Lincoln, Nebraska, 68526

  • Saint Barnabas Medical Center

    Livingston, New Jersey, 07039

  • Keck Hospital of USC

    Los Angeles, California, 90033

  • Cedar-Sinai Heart Institute

    Los Angeles, California, 90048

  • Ronald Regan UCLA Medical Center

    Los Angeles, California, 90095

  • University of Louisville Physicians (ULP)

    Louisville, Kentucky, 40202

  • University Hospital

    Madison, Wisconsin, 53792

  • MidMichigan Medical Center Midland

    Midland, Michigan, 48670

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Yale University School of Medicine

    New Haven, Connecticut, 06510

  • Columbia University Medical Center

    New York, New York, 10032

  • Cardiac & Vascular Research Center of Northern Michigan

    Petoskey, Michigan, 49770

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Virginia Commonwealth University Medical Center

    Richmond, Virginia, 23298

  • University of Utah Health

    Salt Lake City, Utah, 84132

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157

Other trials in United States

Germany18 sites

  • Herz-Und Gefasszentrum Bad Bevensen

    Bad Bevensen, Lower Saxony, 29549

  • Universitats-Herzzentrum Freiburg-Bad Krozingen

    Bad Krozingen, 79189

  • RHON-KLINIKUM Campus Bad Neustadt

    Bad Neustadt an der Saale, 97616

  • Charite-Universitatsmedizin Berlin

    Berlin, Brandenburg, 13353

  • Deutsches Herzzentrum Berlin

    Berlin, 13353

  • Universitatsklinikum Bonn

    Bonn, 53127

  • Universitatsklinikum "Carl Gustav Carus" der Technischen Universitat Dresden Klinik fur Herzchirurgle

    Dresden, 01307

  • Universitatklinicum Essen Westdeutsches Herzzentrum Essen

    Essen, 45122

  • Universitatsklinikum Frankfurt am Main

    Frankfurt am Main, Hesse, 60590

  • Universitasklinikum Giessen und Marburg GmbH

    Geißen, Hesse, 35392

  • Universitatsklinikum Heidelberg und Medizinische Fakultat

    Heidelberg, 69120

  • Klinikum der Friedrich-Schiller-Universitat Jena

    Jena, Deutschland, 07747

  • Herzzentrum Leipzig

    Leipzig, Saxony, 04289

  • Universitatsklinikum Schleswig-Holstein, Campus Lubeck

    Lübeck, 23538

  • Universitatsmedizin der Johannes Gutenberg-Universitat Mainz

    Mainz, 55131

  • Deutsches Herzzentrum Munchen

    München, Bavaria, 80636

  • Herzchirurgische Klinik und Poliklinik

    München, 81377

  • Krankenhaus der Barmherzigen Bruder Trier

    Trier, Rhineland-Palatinate, 54292

Other trials in Germany

Canada12 sites

  • Foothills Medical Centre, Libin Cardiovascular Institute of Alberta, University of Calgary

    Calgary, Alberta, T2N 2T9

  • University of Alberta Hospital / Mazankowski Alberta Heart Institute

    Edmonton, Alberta, TG6 2B7

  • Hamilton General Hospital

    Hamilton, Ontario, L8L2X2

  • London Health Sciences Center, University Hospital

    London, Ontario, N6A5A5

  • Centre Hospitalier de l'Universite de Montreal (CHUM)

    Montreal, Quebec, H2X0C1

  • McGill University Health Center - Royal Victoria Hospital

    Montreal, Quebec, H4A3J1

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y4W7

  • Institut Universitaire de cardiologie et de pneomologie de Quebec, Universite Laval

    Québec, Quebec, G1V4G5

  • Horizon Health Network, Saint John Regional Hospital

    Saint John, New Brunswick, E2L4L2

  • St. Michael's Hospital

    Toronto, Ontario, M5B1W8

  • Royal Jubilee Hospital (Victoria Island Health Authority)

    Victoria, British Columbia, V8R 1J8

  • St. Boniface Hospital

    Winnipeg, Manitoba, R2H2A6

Other trials in Canada

Spain10 sites

  • Hospital Universitario Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital Universitario de Cruces

    Barakaldo, 48903

  • Hospital Universitario Reina Sofia

    Córdoba, Cordoba, 14004

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Universitario de la Princesa

    Madrid, 28006

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario Central de Asturias

    Oviedo, 33011

  • Complejo Hospitalario de Navarra

    Pamplona, Navarre, 31008

  • Hospital Clinico Universitario de Santiago-CHUS

    Santiago de Compostela, A Coruña, 15706

  • Hospital Clinic Universitario de Valencia

    Valencia, 46010

Other trials in Spain

Australia9 sites

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • The Prince Charles Hospital

    Chermside, Qeensland, 4032

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • The Townsville Hospital

    Douglas, Queensland, 4814

  • St. Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

  • Austin Hospital

    Heidelberg, Victoria, 3084

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Westmead Hospital

    Westmead, New South Wales, 2145

  • Princess Alexandra Hospital

    Woolloongabba, Qeensland, 4102

Other trials in Australia

France7 sites

  • CHU Besancon-Service de Chirurgie Thoracique et Cardiovasculaire

    Besançon, 25000

  • CHU - Grenoble Alpes

    Grenoble, 38043

  • CHU Bordeaux

    Pessac, 33604

  • Hospital Robert Debre

    Reims, 51092

  • Chu Pontchaillou Rennes

    Rennes, 35000

  • Hopitaux Universitaires de Strasbourg - Service de Chirurgie Cardiovasculaire

    Strasbourg, 67091

  • CHU Toulouse - Hospital Rangueil-Service de Chirurgie Cadriovasculaire

    Toulouse, 31059

Other trials in France

Austria3 sites

  • Medizinische Universitat Innsbruck

    Innsbruck, Tyrol, 6020

  • Kepler Universitatsklinikum GmbH

    Linz, Upper Austria, 4021

  • Medizinische Universitat Wien

    Vienna, 1090

Other trials in Austria

Czechia3 sites

  • Fakulni nemocnice Hradec Kralove, Kardiochirurgicka klinika

    Hradec Králové, 500 05

  • Institut klinicke a experimenalni mediciny, Klinika kardiovaskularni chirurgie

    Prague, 140 21

  • Fakultni nemocnice Motol a 2. LF UK, Klinika kariovaskularni chirurgie 2. LF. UK

    Prague, 15006

Other trials in Czechia

New Zealand3 sites

  • Auckland City Hospital

    Auckland, 1023

  • Waikato Hospital

    Hamilton, 3204

  • Wellington Regional Hospital

    Wellington, 6021

Other trials in New Zealand

United Kingdom2 sites

  • Royal Papworth Hospital NHS Foundation Trust

    Cambridge, Cambridgeshire, CB2 0AY

  • Guy's and St Thomas Hospital

    London, SE1 7EH

Other trials in United Kingdom

Belgium1 site

  • University Hospital Leuven, Campus Gasthuisberg

    Leuven, 3000

Other trials in Belgium

About this study

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

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.

Read the 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.

Conditions
Cardiac Surgery
Being tested
teprasiran, Placebo
Keywords
MAKE, AKI

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • teprasiranDrug

    Also called QPI-1002

    IV injection

  • PlaceboDrug

    isotonic saline

Study groups in NCT03510897
Study groupRoleWhat they receive
QPI-1002Active comparatorQPI-1002 Injection, Single dose
Receives: Drug: teprasiran
PlaceboPlacebo comparatorisotonic saline
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of subjects through day 90 who develop major adverse kidney events

    Measured: Baseline through day 90

Secondary outcomes (3)

  1. Proportion of subjects developing AKI overall by modified AKIN criteria within 5 days post-surgery

    Measured: Baseline through day 5

  2. Renal function as estimated by glomerular filtration rate

    Measured: Baseline through Day 90

  3. Proportion of subjects who die or initiate dialysis through day 90

    Measured: Baseline through day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2018
  2. Study start29 Jun 2018
  3. Primary completion14 Oct 2020
  4. Study completion12 Apr 2021

Why it stopped: Study completed day 90 for primary endpoint but was terminated early for one year follow up due to results not meeting efficacy outcome at Day 90.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,043 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03510897
Sponsor's protocol ID
QRK309
Status last verified
Jul 2021
First submitted
18 Apr 2018
Last updated
16 Jul 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 38689404

  • 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.

    PubMed 34474590

  • 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.

    PubMed 33239393

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing teprasiran in people with Cardiac Surgery, run by Quark Pharmaceuticals at 104 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 104 sites in United States, Germany, Canada, Spain, Australia and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study completed day 90 for primary endpoint but was terminated early for one year follow up due to results not meeting efficacy outcome at Day 90.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects through day 90 who develop major adverse kidney events (time frame: Baseline through day 90). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03510897, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2021.

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