Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2015-003113-15
    Sponsor's Protocol Code Number:QRK209
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-05-30
    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 ConcernedGermany - BfArM
    A.2EudraCT number2015-003113-15
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 2 Study to see if QPI-1002 is effective and safe of 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 2 AKI
    A.4.1Sponsor's protocol code numberQRK209
    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 Address6501 Dumbarton Circle
    B.5.3.2Town/ cityFremont
    B.5.3.3Post codeCA 94555
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/10/751
    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 19.1
    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 Yes
    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 acute kidney injury (AKI) in subjects at high risk for 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. Male or female, age ≥ 45 years old.
    3. Have stable renal function per Investigator assessment and no known increase in serum creatinine of ≥ 0.3 mg/dL (≥ 26.4 μmol/l) during preceding 4 weeks.
    4. Scheduled to undergo non-emergent open chest cavity cardiovascular surgeries, including use of coronary pulmonary bypass (CPB) and no CPB:
    a. 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;
    b. Surgery of more than one cardiac valve (valve surgery) and at least 1 AKI Risk Factor;
    c. Surgery of the aortic root or ascending part of the aorta, or aortic valve, including circulatory arrest and at least 1 AKI Risk Factor;
    d. Aortic root or ascending part of the aorta, combined with CABG and/or valve(s) surgery, including circulatory arrest and at least 1 AKI Risk Factor;
    e. If only CABG or single valve surgery, subjects are required to have at least 2 AKI Risk Factors:
    Note: TAVI/TAVR are allowed only if performed in combination with surgeries defined in Inclusion
    Criteria #4.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
    5. Are up-to-date on cancer screening according to site-specific pre-operative standard of care and 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 in situ or cervical carcinoma in situ.
    6. 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 l 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 serum pregnancy test within 48 hours prior to cardiac surgery and be using a highly effective means of contraception or using 2 methods of birth control concurrently, whichever is more stringent, which will be continued until the Day 90 visit.
    7. A male subjects with female partners of childbearing potential must agree to use an effective means of contraception (per the 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
    2. 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 (< 26.4 μmol/l) in at least 2 serum creatinine evaluations performed not less than 36 hours 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
    5. Scheduled to undergo transcatheter aortic valve implantation (TAVI) or transcatheter aortic valve
    replacement (TAVR) only* or single vessel, mid-CAB off-pump surgeries or left ventricular assist device
    (LVAD) implantation
    *Note: See Inclusion Criteria #4.
    6. Have participated in an investigational drug study in the last 30 days
    7. Have a known allergy to or had participated in a prior study with siRNA
    8. Have a history of human immunodeficiency virus (HIV) infection
    9. 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)
    10. 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.
    11. 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)
    12. 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).
    13. Are receiving ≥ 3 concurrent vasopressors to maintain hemodynamic stability (as defined in the protocol)
    14. Have required cardiopulmonary resuscitation within 14 days prior to cardiac surgery
    15. 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
    16. Have total bilirubin or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 times the upper limit of normal (ULN) at time of screening
    17. Have Child Pugh Class A liver disease with ALT/AST above the upper limit of normal or Class B or higher
    18. 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.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects developing AKI as defined by the AKIN criteria based on serum creatinine component only (Stage I, Stage II, or Stage III) through Day 5.
    E.5.1.1Timepoint(s) of evaluation of this end point
    through Day 5
    E.5.2Secondary end point(s)
    1. Proportion of subjects developing at least one 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
    2. Proportion of subjects developing at least one of the following events: death, needing RRT during the 90 day post-operative period, or having a ≥ 25% reduction in S-cystatin C based eGFR at the Day 90 visit
    3. Proportion of subjects developing at least one of the following events: AKI by the AKIN criteria of at least 3 days duration in which the initial serum creatinine increase occurs within 48 hours of the completion of the surgery or an increase in IL-18 level to ≥ 90 pg/ml from baseline within 5 days in which the initial IL- 18 increase occurs within 48 hours of the completion of the surgery
    4. Proportion of subjects developing AKI within 5 days post-surgery as defined by the AKIN (Acute Kidney Injury Network) scoring criteria a) overall (all stages combined), b) by stage
    5. Proportion of subjects developing AKI within 5 days post-surgery as defined by the AKIN (Acute Kidney Injury Network scoring criteria by duration categories
    6. Proportion of subjects developing AKI within 5 days post-surgery as defined by the RIFLE (Risk, Injury, Failure, Loss or ESRD) scoring criteria: a) overall (all stages combined), b) by stage
    7. Proportion of subjects developing AKI within 5 days post-surgery as defined by the RIFLE (Risk, Injury, Failure, Loss or ESRD) scoring criteria by duration categories
    8. Proportion of subjects developing AKI within 5 days post-surgery as defined by the KDIGO (Kidney Disease Improving Global Outcomes) scoring criteria: a) overall (all stages combined), b) by stage
    9. Proportion of subjects developing AKI within 5 days post-surgery as defined by the KDIGO (Kidney Disease Improving Global Outcomes) scoring criteria by duration categories
    10. Proportion of subjects developing AKI as defined by AKIN criteria based on urine output (UO) only
    11. Number and duration of dialysis (days) within 30 and 90 days
    12. Changes from baseline in SCr and S-cystatin C at all study visits from Day 0 to Day 90
    13. Maximal change from baseline in SCr and S-cystatin C until Day 7 or until hospital discharge, whichever is first
    14. Changes from baseline in SCr-based eGFR and S-cystatin C-based eGFR at all study visits from Day 0 to Day 90
    15. Maximal change from baseline in AKI biomarkers (urine: NGAL, KIM 1, IL-18, and TIMP-2*IGFBP7; and serum: NGAL and others) through 72 hours, Day 5 and Day 7
    16. Changes from baseline in AKI biomarkers (urine: NGAL, KIM 1, IL-18, and TIMP-2*IGFBP7; and serum: NGAL and others) at all study visits from Day 0 to Day 90
    17. Proportion of subjects reaching > 0.3 ng/mL2/1,000 level of the multiplication product of urine TIMP-2 and urine IGFBP7 biomarkers (TIMP-2 * IGFBP7) at any time through Day 5 and Day 7
    18. Duration of biomarker level increase from baseline (urine: NGAL, KIM 1, IL-18, and TIMP-2*IGFBP7; and serum: NGAL and others) through Day 5; Day 7. Note: The biological significant increase threshold for each biomarker will be prospectively defined in the Statistical Analysis Plan.
    19. The proportion of subjects in each treatment group who have maximal change from baseline biomarker values falling within the upper tertile of the overall study population (urine: NGAL, KIM 1, IL-18, and TIMP-2*IGFBP7; and serum: NGAL and others)
    20. Number of hospitalizations and number of days hospitalized through Day 30 and 90
    21. Number of ICU days during initial hospitalization
    22. Number of hospital days during the initial hospitalization
    E.5.2.1Timepoint(s) of evaluation of this end point
    from Day 0 to 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
    Optional Assessment of Biomarkers
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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
    Germany
    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 subject survival and malignancy status.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 years1
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state75
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 340
    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 Decision2016-07-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-03-05
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Mon Apr 29 07:50:35 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA