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    Summary
    EudraCT Number:2015-003078-33
    Sponsor's Protocol Code Number:QRK306
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-09-28
    Trial 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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2015-003078-33
    A.3Full title of the trial
    A Phase 3, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of QPI-1002 for Prevention of Delayed Graft Function in Recipients of a Donation After Brain Death Older Donor Kidney Transplant
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3, Randomized, Double-blind, Placebo Controlled Study in order to assess the Efficacy and Safety of QPI-1002 for Prevention of Patients Undergoing Kidney Transplantation from deceased donors
    A.3.2Name or abbreviated title of the trial where available
    QPI-1002 Phase 3 DGF
    A.4.1Sponsor's protocol code numberQRK306
    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-mailjlynn@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 the prevention of Delayed Graft Function in patients receiving renal transplants. The patient population of the current study will include patients undergoing deceased donor renal transplantation who are at risk for DGF.
    E.1.1.1Medical condition in easily understood language
    Kidney recipients with high likelyhood to induce a problematic medical situation after transplantation (Delayed Graft Function). The investigational compound shall minimize the risk of such problems.
    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 19.0
    E.1.2Level PT
    E.1.2Classification code 10076664
    E.1.2Term Delayed graft function
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To determine the efficacy of QPI-1002 to reduce the incidence and severity of delayed graft function in comparison to placebo in recipients of a donation after brain death (DBD) older donor kidney.
    2. To assess the safety and tolerability of QPI-1002 in comparison to placebo when administered to recipients of a DBD donor kidney.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Has the ability to understand the requirements of the study, is able to provide written informed consent (including consent for the use and disclosure of research related health information) and is willing and able to comply with the requirements of the study protocol (including required study visits).
    2. Male or female at least 18 years of age.
    3. Has dialysis dependent renal failure initiated at least 2 months prior to transplantation.
    4. Is to be a recipient of a transplant from a deceased donor (brain death criteria) ≥ 45 years of age.
    5. Based on donor age, the following requirements for the risk of DGF (determined using the Irish DGF risk assessment nomogram) and cold ischemia time (CIT) must be met:
    a. Donor age 45 – 59 years: estimated DGF risk >= 20% and estimated CIT >= 10 hour
    b. Donor age >= 60 years: no minimum estimated DGF risk or minimum estimated CIT
    6. Is able to comply with the requirement of antibody induction therapy with rabbit polyclonal anti-thymocyte globulin or anti-CD25 (anti-IL2R) monoclonal antibodies per center standard of care.
    7. 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 serum or urine pregnancy test within 48 hours prior to transplant surgery and be using an effective means of contraception (per the site-specific guidelines or using 2 methods of birth control concurrently, whichever is more stringent) which will be continued until the Day 180 visit.
    8. 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 180 visit.
    9. Must be up-to-date on cancer screening according to site-specific guidelines and past medical history must be negative for biopsy-confirmed malignancy within 5 years of randomization, with the exception of adequately treated basal cell or squamous cell carcinoma in situ or carcinoma of the cervix in situ.
    E.4Principal exclusion criteria
    1. Recipient of a live donor kidney or a kidney from a donation after cardiac death (DCD) donor.
    2. Recipient of donor kidney preserved with normothermic machine perfusion.
    3. Scheduled to undergo multiorgan transplantation.
    4. Has a planned transplant of kidneys that are implanted en bloc (dual kidney transplant).
    5. Has planned transplant of dual kidneys (from the same donor) transplanted not en bloc.
    6. Has lost first kidney transplant due to graft thrombosis.
    7. Is scheduled for transplantation of a kidney from a donor who is known to have received an investigational therapy under another IND/CTA for ischemic/reperfusion injury immediately prior to organ recovery.
    1. Recipient of a live donor kidney or a kidney from a donation after cardiac death (DCD) donor.
    2. Recipient of donor kidney preserved with normothermic machine perfusion.
    3. Scheduled to undergo multiorgan transplantation.
    4. Has a planned transplant of kidneys that are implanted en bloc (dual kidney transplant).
    5. Has planned transplant of dual kidneys (from the same donor) transplanted not en bloc.
    6. Has lost first kidney transplant due to graft thrombosis.
    7. Is scheduled for transplantation of a kidney from a donor who is known to have received an investigational therapy under another IND/CTA for ischemic/reperfusion injury immediately prior to organ recovery.
    8. Is scheduled to receive an ABO-incompatible donor kidney.
    9. Has a positive T- or B-cell cross-match by NIH anti-globulin lymphocytotoxicity method or CDC cross-match method, if performed.
    10. Has a positive T- or B-cell flow cross-match AND donor specific anti-HLA antibody (DSA) detected by flow cytometry, Luminex® based antigen-specific anti-HLA antibody testing, or by similar methodology, if performed.
    11. Has undergone desensitization to remove donor specific anti-HLA antibodies prior to transplantation.
    12. Has participated in an investigational study within the last 30 days or received an investigational product within 5 half-lives of the study drug administration, whichever is longest.
    13. Has known allergy to or has participated in a prior study with siRNA.
    14. Has a history of HBV (Note: subjects with a serological profile suggestive of clearance, or prior antiviral treatment of a prior HBV infection, may be enrolled with the approval of the Medical Monitor).
    15. Has a history of HIV.
    16. Recipient of a known HIV positive donor kidney.
    17. Is HCV-positive (detectable HCV RNA) (Note: Subjects at least 24 weeks from completion of treatment with an approved antiviral regimen and who remain free of HCV as determined by HCV RNA testing may be enrolled. Subjects who have been cleared of HCV virus after treatment with an unapproved regimen should be approved by the Medical Monitor).
    18. Has history or presence of a medical condition or disease or psychiatric condition that in the investigator's assessment would place the patient at an unacceptable risk for study participation.
    E.5 End points
    E.5.1Primary end point(s)
    1. The primary endpoint for the study is delayed graft function (DGF) , defined as the as the number of dialysis sessions through Day 30 for subjects who started dialysis beginning in the first 7 days post-transplant.
    a. Dialysis sessions will be counted through Day 30 post-transplant, or until a 7 day dialysis free period occurs, whichever occurs first. Individual hemo- or peritoneal dialysis sessions will be counted individually. Subjects who receive continuous peritoneal filtration will count as 3 sessions/week. Continuous hemofiltration will also be counted as 3 sessions/week.
    b. A subject who does not have DGF (i.e., dialysis in the first 7 days post-transplant) will be classified as having 0 dialysis sessions.
    c. Subjects who drop out on or before Day 7, regardless of the reason for dropout (e.g., experience primary non-function (PNF), graft loss, death or lost-to-follow up), will be considered to have failed the primary endpoint and will be assigned the maximum number of dialysis sessions from the day of dropout. Dialysis session is defined in the protocol. The maximum number of dialysis sessions will be the observed number of dialysis sessions (to the point of drop out or loss) plus 3 dialysis sessions per week from that point to Day 30. This reflects the typical practice of administration of 3 dialysis sessions per week inclusive of the actual number of dialysis sessions observed. PNF is defined for efficacy analysis as continuous requirement for dialysis starting in the first 7 days after transplant and lasting for at least 60 days post-transplant.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 30 for subjects who started dialysis beginning in the first 7 days post-transplant
    E.5.2Secondary end point(s)
    1. The proportion of subjects requiring dialysis for any reason in the first 7 days post-transplant.
    2. The proportion of subjects with a fall in serum creatinine of ≥ 10% on three consecutive days in the first 7 days post-transplant.
    E.5.2.1Timepoint(s) of evaluation of this end point
    7 days post-transplant
    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) 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 EEA32
    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
    Argentina
    Australia
    Belgium
    Brazil
    Canada
    Czech Republic
    France
    Germany
    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 end of the trial will be declared after the last subject, last visit (LPLV), and data from that visit have been included into the database.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months1
    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: 507
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 127
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 210
    F.4.2.2In the whole clinical trial 634
    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 Decision2016-09-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-02
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-02-22
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