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Acute Kidney InjuryPhase 2NCT02610283

A Study to Evaluate Efficacy and Safety of QPI-1002 for Prevention of Acute Kidney Injury Following Cardiac Surgery

A Phase 2 study testing QPI-1002 in people with Acute Kidney Injury, run by Quark Pharmaceuticals at 36 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This trial is designed to evaluate QPI-1002 versus placebo for the prevention of AKI in subjects who are at high risk for AKI 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 45 years and older
Conditions the study is for
Acute Kidney Injury
What is being tested?
QPI-1002
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
341 participants
Where
36 sitesin 3 countries
Study dates
Dec 2015to Apr 2018
Phase
Phase 2
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 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have the ability to understand the requirements of the study, are able to provide written informed consent and are willing and able to comply with the requirements of the study
  • Male or female, age ≥ 45 years old.
  • Have stable renal function per Investigator assessment and no known increase in serum creatinine of ≥ 0.3 mg/dL during preceding 4 weeks.
  • Scheduled to undergo non-emergent open chest cavity cardiovascular surgeries, including use of coronary pulmonary bypass (CPB) and no CPB:
  • Combined coronary artery bypass grafting (CABG) surgery and surgery of one or more cardiac valve (valve(s) surgery) and at least 1 AKI Risk Factor;
  • Surgery of more than one cardiac valve (valve surgery) and at least 1 AKI Risk Factor;
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  • Surgery of the aortic root or ascending part of the aorta, or in combination with the aortic valve, and at least 1 AKI Risk Factor; circulatory arrest is not excluded;
  • Aortic root or ascending part of the aorta, combined with CABG and/or valve(s) surgery and at least 1 AKI Risk Factor; circulatory arrest is not excluded;
  • If only CABG or single valve surgery, subjects are required to have at least 2 AKI Risk Factors:
  • AKI Risk Factors:
  • Age ≥ 70 years
  • eGFR ≤ 60 ml/min/1.73m2 by CKD-EPI formula at Screening.
  • Diabetes (Type 1 or 2), requiring at least 1 oral hypoglycemic agent or insulin
  • Proteinuria ≥ 0.3g/d, spot UPCR ≥ 0.3g/gm or urine dip stick ≥ +2
  • History of congestive heart failure requiring hospitalization

Who cannot join

  • Have an eGFR ≤ 20 mL/min/1.73 m2
  • Subjects with an eGFR ≤ 60 mL/min/1.73 m2 requiring intravascular iodinated contrast within 48 hours of the day of surgery. However, subjects may be included if the post contrast increase in serum creatinine is < 0.3 mg/dl in at least 2 serum creatinine evaluations performed not less than 36 hours apart.
  • Have a history of any organ or cellular transplant which requires active immunosuppressive treatment which can interfere with kidney function
  • Emergent surgeries, including aortic dissection, and major congenital heart defects
  • Scheduled to undergo transcatheter aortic valve implantation (TAVI) or transcatheter aortic valve replacement (TAVR) or single vessel, mid-CAB off-pump surgeries or left ventricular assist device (LVAD) implantation
  • Have participated in an investigational drug study in the last 30 days
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  • Have a known allergy to or had participated in a prior study with siRNA
  • Have a history of human immunodeficiency virus (HIV) infection
  • Have known active Hepatitis B (HBV) (Note: Subjects with a serological profile suggestive of clearance, or prior antiviral treatment of HBV infection may be enrolled)
  • Are HCV-positive (detectable HCV RNA) (Note: Subjects at least 24 weeks from completion of treatment with an antiviral regimen and who remain free of HCV as determined by HCV RNA testing may be enrolled.)
  • Have had cardiogenic shock or hemodynamic instability within the 24 hours prior to surgery, requiring inotropes or vasopressors or other mechanical devices such as intra-aortic balloon counter-pulsation (IABP)
  • Have required any of the following within a week prior to cardiac surgery: defibrillator or permanent pacemaker, mechanical ventilation, IABP, left ventricular assist device (LVAD), other forms of mechanical circulatory support (MCS) (Note: The prophylactic insertion of an IABP preoperatively for reasons not related to existing LV pump function is not exclusionary).
  • Have required cardiopulmonary resuscitation within 14 days prior to cardiac surgery
  • Have ongoing sepsis or history of sepsis within the past 2 weeks or untreated diagnosed infection prior to Screening visit. Sepsis is defined as presence of a confirmed pathogen, along with fever or hypothermia, and hypoperfusion or hypotension
  • Have total bilirubin or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 times the upper limit of normal (ULN) at time of screening
  • Have Child Pugh Class A liver disease with ALT/AST above the upper limit of normal or Class B or higher. (This criterion is only applicable in a patient population with underlying chronic liver disease, i.e., cirrhosis.)

Trial locations and contacts

36 sites in 3 countries.

36 sites in 3 countries

United States20 sites

  • Johns Hopkins University

    Baltimore, Maryland, 21287

  • Suburban Hospital

    Bethesda, Maryland, 20814

  • Lindner Research Center, The Christ Hospital

    Cincinnati, Ohio, 45219

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44111

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

  • Baylor University

    Dallas, Texas, 75246

  • Duke University

    Durham, North Carolina, 27710

  • Indiana Ohio Heart

    Fort Wayne, Indiana, 46804

  • University of Florida

    Gainesville, Florida, 32610

  • St. Vincent Medical Group

    Indianapolis, Indiana, 46290

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • River City Clinical Research

    Jacksonville, Florida, 32216

  • Bryan Heart

    Lincoln, Nebraska, 68506

  • Mid Michigan Cardiovascular Research

    Midland, Michigan, 48670

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Columbia University

    New York, New York, 10032

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453

  • Cardiac & Vascular Research Center of Northern Michigan

    Petoskey, Michigan, 49770

  • Washington University

    St Louis, Missouri, 63110

  • University of Arizona Sarver Heart Center

    Tucson, Arizona, 85724

Other trials in United States

Canada8 sites

  • Hamilton Health Sciences

    Hamilton, Ontario, L8L 2X2

  • Centre hospitalier de l'universite de Montreal

    Montreal, Quebec, H2W 1T8

  • Mcgill University Health Center - Royal Victoria Hospital

    Montreal, Quebec, H4A 3J1

  • Montreal Heart Institute

    Montreal, Quebec, J0N 1P0

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Z4W7

  • Instiut Universitaire de Cardiologie et Pneumologie de Quebec

    Québec, Quebec, G1V4G5

  • St. John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

Other trials in Canada

Germany8 sites

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117

  • Klinikum der Universität zu Köln

    Cologne, 50937

  • Herzzentrum Dresden GmbH

    Dresden, 01307

  • Westdeutsches Herzzentrum Essen / Universitätsklinikum Essen

    Essen, 45122

  • Universitätsklinikum Giessen und Marburg / Standort Giessen / Zentrum für Chirurgie

    Giessen, 35385

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • Herzzentrum Leipzig GmbH

    Leipzig, 04289

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55131

Other trials in Germany

About this study

Official title: A Randomized, Double-Blind, Placebo Controlled , Phase 2 Study to Evaluate the Efficacy and Safety of QPI-1002 for the Prevention of Acute Kidney Injury in Subjects at High Risk for AKI Following Cardiac Surgery

This trial is designed to evaluate QPI-1002 versus placebo for the prevention of AKI in subjects who are at high risk for AKI 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 2 trial to evaluate QPI-1002 versus placebo for the prevention of AKI in subjects who are at high risk for AKI following cardiac surgery.

Being tested
QPI-1002, Placebo
Keywords
AKI
Medical subject headings
Acute Kidney Injury

What participants receive

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

  • QPI-1002Drug

    IV injection

  • PlaceboDrug

    isotonic saline

Study groups in NCT02610283
Study groupRoleWhat they receive
QPI-1002Active comparatorQPI-1002 Injection, single dose
Receives: Drug: QPI-1002
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 developing AKI as defined by the AKIN criteria

    Measured: Baseline through Day 5

Secondary outcomes (1)

  1. Proportion of subjects developing at least on of the following events: death, needing renal replacement therapy (RRT) during the 90-day post-operative period, or having a ≥ 25% reduction in SCr based eGFR at the Day 90 visit

    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 posted20 Nov 2015 (estimated)
  2. Study startDec 2015
  3. Primary completionFeb 2018
  4. Study completionApr 2018

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
341 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02610283
Sponsor's protocol ID
QRK209
Status last verified
Apr 2018
First submitted
18 Nov 2015
Last updated
10 Jan 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing QPI-1002 in people with Acute Kidney Injury, run by Quark Pharmaceuticals at 36 sites in 3 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 15 inclusion and 16 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: finished, as of the sponsor's last update on 10 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States, Canada, Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 developing AKI as defined by the AKIN criteria (time frame: Baseline through Day 5). 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 NCT02610283, which also lists 1 linked publication.

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 10 Jan 2019.

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