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    Summary
    EudraCT Number:2018-000757-49
    Sponsor's Protocol Code Number:QRK309
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-07-04
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedAustria - BASG
    A.2EudraCT number2018-000757-49
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 3 Study to see if QPI-1002 is effective and safe for the Prevention of Acute Kidney Injury in Subjects at High Risk for AKI following Cardiac Surgery
    A.3.2Name or abbreviated title of the trial where available
    QPI-1002 Phase 3 AKI
    A.4.1Sponsor's protocol code numberQRK309
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03510897
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorQuark Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportQuark Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationQuark Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street Address7999 Gateway Blvd., Suite 310
    B.5.3.2Town/ cityNewark
    B.5.3.3Post codeCA 94560
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 510 402 4020
    B.5.5Fax number+1 510 402 4021
    B.5.6E-maildcafaro@quarkpharma.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameI5NP
    D.3.2Product code QPI-1002
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot applied
    D.3.9.1CAS number 1231737-88-4
    D.3.9.2Current sponsor codeQPI-1002
    D.3.9.3Other descriptive nameI5NP
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typesynthetic short interference (si) ribonucleic acid (RNA)
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous bolus use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    QPI-1002 is being developed for prevention of acute kidney injury (AKI) in patients at risk for AKI following cardiac surgery and for reduction in the incidence and severity of delayed graft function after kidney transplantation.
    E.1.1.1Medical condition in easily understood language
    The investigational compound shall minimize the risk of patients after cardiac surgery with high likelyhood to induce a problematic medical situation with the kidneys
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10069339
    E.1.2Term Acute kidney injury
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To assess the efficacy of a single intravenous (IV) infusion of QPI-1002 in preventing Major Adverse Kidney
    Events (MAKE) in subjects at high risk for acute kidney injury (AKI) following cardiac surgery.
    • To assess the safety and tolerability of an IV infusion of QPI-1002 in comparison to placebo when
    administered to subjects at high risk for AKI following cardiac surgery.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Have the ability to understand the requirements of the study, are able
    to provide written informed consent (including consent for the use and
    disclosure of research related health information) and are willing and
    able to comply with the requirements of the study (including required
    study visits)
    2. Adult male or female, age ≥ 18 years old
    3. Have stable pre-operative renal function per Investigator assessment
    and no known increase in Serum creatinine (SCr) of ≥ 0.3 mg/dL (≥ 26.4
    μmol/L) during preceding 28 days as assessed by the site's local
    laboratory using standard assay methodology.
    4. At risk for AKI following cardiac surgery on the basis of at least one of
    the following pre-operatively
    assessed risk factors:
    a) eGFR (defined using Chronic Kidney Disease Epidemiology
    Collaboration (CKD-EPI) SCr formula) of
    < 60 mL/min/1.73 m2
    b) Diabetes with ongoing insulin treatment (defined as known type 2 or
    type 1 diabetes requiring prescribed insulin usage prior to
    hospitalization for cardiac surgery)
    c) Albuminuria defined as Urine Albumin/Creatinine ratio > 30 mcg/mg
    or screening urine dipstick of 1+
    Note: If albuminuria is the only possible risk factor (i.e. eGFR is ≥ 60
    mL/min/1.73 m2 and subject does not have a history of diabetes
    requiring prescribed insulin usage), a dipstick must be confirmed by
    urinalysis as > 30 mcg albumin/mg creatinine. If the urine albumin
    creatinine ratio is not available, and albuminuria is the only possible risk
    factor, a dipstick value of ≥ 2+ for protein or equivalent may be
    considered as meeting the albuminuria definition (> 30 mcg albumin/mg
    creatinine).
    5. Undergoes non-emergent open chest cavity cardiovascular surgeries,
    with use of cardiopulmonary bypass (CPB) pump, with or without
    hypothermic circulatory arrest:
    a) Combined coronary artery bypass grafting (CABG) surgery and
    surgery of one or more cardiac valve
    (valve(s) surgery)
    b) Only CABG or single valve surgery that is a "redo" surgery (i.e.
    subject had any previous open chest
    cavity cardiovascular surgery)
    c) Surgery of more than one cardiac valve (valve surgery)
    d) Surgery of the aortic root or ascending part of the aorta in
    combination with CABG and/or valve(s)
    surgery
    e) If only CABG or single valve surgery and that surgery is not a "redo"
    surgery (i.e. not the surgery
    described in Inclusion Criteria #5b), subjects are required to have at
    least one additional risk factor for
    AKI: either one additional risk factor from Inclusion Criterion #4 above
    (for a total of two risk factors
    from Inclusion Criterion #4 above), OR age ≥ 65 years old, OR history of
    congestive heart failure
    requiring hospitalization, OR type 2 diabetes requiring at least 1 oral
    hypoglycemic agent but not
    requiring insulin
    Note: Transcatheter aortic valve implantation (TAVI) or transcatheter
    aortic valve replacement (TAVR)
    are allowed only if performed in combination with surgeries defined in
    Inclusion Criterion #5.
    *Note: "Non-emergent surgery" would denote an operation that does
    not require prompt and immediate surgery (within a few hours or the
    same day) and is scheduled in advance.
    6. No known cancer as identified by cancer screening according to sitespecific
    pre-operative standard of care
    7. Past medical history must be negative for malignancy within 5 years
    of randomization, with the exception of adequately treated basal cell or
    squamous cell carcinoma, or cervical carcinoma in situ
    8. A female subject is eligible to enter the study if she is:
    a) Not pregnant or nursing
    b) Of non-childbearing potential (i.e., post-menopausal defined as
    having been amenorrheic for at least 1 year prior to screening, or has had
    a bilateral tubal ligation at least 6 months prior to administration of
    study drug or bilateral oophorectomy or complete hysterectomy)
    c) If of childbearing potential, must have a negative urine or serum
    pregnancy test within 48 hours prior to cardiac surgery and be using a
    highly effective means of contraception (per site-specific guidelines or
    use 2 methods of birth control concurrently, whichever is more
    stringent), which will be continued until the Day 90 visit
    9. Male subjects with female partners of childbearing potential must
    agree to use an effective means of contraception (per site-specific
    guidelines or use 2 methods of birth control concurrently, whichever is
    more stringent), which will be continued until the Day 90 visit
    E.4Principal exclusion criteria
    1. Have an eGFR ≤ 20 mL/min/1.73 m2 (defined using CKD-EPI SCr
    formula)
    2. Subjects with an eGFR < 60 mL/min/1.73 m2 (defined using CKD-EPI
    SCr formula) requiring intravascular iodinated contrast within 48 hours
    of surgery initiation as defined by the planned skin incision. However,
    subjects may be included if the post contrast increase in SCr is < 0.3
    mg/dL (< 26.4 μmol/L) in at least 2 SCr evaluations performed not less
    than 36 hours (post final dose of contrast) apart
    3. Have a history of any organ or cellular transplant which requires
    active immunosuppressive treatment which can interfere with kidney
    function
    4. Emergent surgeries, including aortic dissection, and major congenital
    heart defects
    *Note: See Inclusion #5. Also, "emergent surgeries" are defined as
    cardiac operations that are not elective and must be done promptly to
    address an immediately life-threatening condition.
    5. Undergoes cardiac surgery off CPB for subjects ≥ 45 years
    old.(Cardiac Surgery off CPB for subjects < 45 years old is allowed.)
    6. Undergoes TAVI or TAVR only* or single vessel, minimally invasive
    direct coronary artery bypass (MIDCAB) off-pump surgeries or left ventricular assist device (LVAD)
    implantation
    *Note: See Inclusion Criterion #5
    7. Have participated in an investigational drug study in the last 30 days
    8. Have a known allergy to or had participated in a prior study with small
    interfering ribonucleic acid (siRNA) or prior treatment with QPI-1002
    9. Have a known history of human immunodeficiency virus (HIV)
    infection
    10. 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)
    11. Have known active Hepatitis C (HCV) (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.)
    12. 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)
    13. Post cardiac surgery, have hemodynamic instability despite
    increasing doses of three types of vasopressors and/or inotropes (see
    Appendix 1)
    14. Perioperative or post cardiac surgery, an LVAD is inserted or
    anticipated (Note: Unplanned intraoperative LVAD that is removed
    before the end of surgery (i.e. skin closure) is allowed.)
    15. Post cardiac surgery, have bleeding > 300 mL/hr requiring return to
    surgery or ≥ 3 units of packed Red Blood Cells (RBC) in the first 2 hours
    post-surgery
    16. Have required any of the following within 7 days prior to cardiac
    surgery: defibrillator, mechanical
    ventilation, IABP, 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.)
    17. Have required cardiopulmonary resuscitation (CPR) within 14 days
    prior to cardiac surgery
    18. 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
    19. Have total bilirubin or alanine aminotransferase (ALT) or aspartate
    aminotransferase (AST) > 2 times the upper limit of normal (ULN) at
    time of screening
    20. Have a history of chronic liver disease (i.e. cirrhosis) and Child Pugh
    Class A liver disease with ALT/AST above the upper limit of normal, or
    Class B or higher
    21. Have a history or presence of a medical condition or disease or
    psychiatric condition that in the Investigator's assessment would render
    the subject ineligible for study participation
    22. Have planned or actual administration of methylene blue from 24
    hours prior to surgery through the time of planned randomization
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint
    1. Proportion of subjects who develop any of the components of MAKE90, defined as either:
    • Death through day 90
    • Initiation of Renal Replacement Therapy (RRT) through day 90, or
    • A ≥ 25% reduction in eGFR at the Day 90 visit
    Note: For the primary analysis, eGFR will be based on serum cystatin C (eGFRcys). Estimated GFR based on serum creatinine (eGFRcreat) will be used in a sensitivity analysis
    E.5.1.1Timepoint(s) of evaluation of this end point
    Through Day 90
    E.5.2Secondary end point(s)
    Key Secondary Efficacy Endpoints
    1. Proportion of subjects developing AKI overall by modified Acute Kidney Injury Network (AKIN) criteria within 5 days post-surgery by SCr
    2. Proportion of subjects who develop any of the components of MAKE90, defined as either:
    • Death through day 90
    • Initiation of RRT through day 90, or
    • A ≥ 25% reduction in eGFR at the Day 90 visit
    Note: This secondary analysis is identical to the primary efficacy analysis except that it will include all
    subjects regardless of age. Thus, eGFRcys will be used for this analysis. eGFRcreat will be used in a
    sensitivity analysis.
    3. Proportion of subjects developing AKI within 5 days post-surgery as defined by modified AKIN criteria stage 2 and stage 3 combined by SCr
    4. Proportion of subjects who develop either or both of the following:
    • Death through day 90
    • Initiation of RRT through day 90
    E.5.2.1Timepoint(s) of evaluation of this end point
    Through Day 90
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    NGAL-Biomarker-Assessment and Optional Assessment of mGFR
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA47
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Austria
    Belgium
    Canada
    Czech Republic
    France
    Germany
    New Zealand
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The study ends when the last data element is available from the last subject to complete the Day 90 visit. However, there will be a Day 365 interaction to determine renal function, subject survival and malignancy status.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 168
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 920
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state21
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 1088
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Once a subject completes the participation in the trial the subject will be treated according to standard clinical practice at participating institutions.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-08-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-03-30
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