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    Summary
    EudraCT Number:2010-020989-20
    Sponsor's Protocol Code Number:QRK.006 Part B
    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:2010-11-23
    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 ConcernedGermany - BfArM
    A.2EudraCT number2010-020989-20
    A.3Full title of the trial
    Controlled, Randomized, Prospective, Double-Blind, Multicenter, Phase I/II, Dose-Escalation Study of the Safety, PK, and Clinical Activity of I5NP for Prophylaxis of Delayed Graft Function in Patients Undergoing Deceased Donor Kidney Transplantation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Controlled, Randomized, Prospective, Double-Blind, Multicenter, Phase I/II, Dose-Escalation Study in order to assess the Safety, the behaviour of the investigational product in the human body and the Clinical Activity of I5NP to prevent Delayed Graft Function in Patients Undergoing Kidney Transplantation from deceased donors
    A.3.2Name or abbreviated title of the trial where available
    I5NP Prophylaxis of Delayed Graft Function in Kidney Transplant
    A.4.1Sponsor's protocol code numberQRK.006 Part B
    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 supportCTI Clinical Trial and Consulting Services Europe GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCTI Clinical Trial and Consulting Services Europe GmbH
    B.5.2Functional name of contact pointHarald von Eick (Managing Director)
    B.5.3 Address:
    B.5.3.1Street AddressLise-Meitner-Strasse 9
    B.5.3.2Town/ cityUlm
    B.5.3.3Post code89081
    B.5.3.4CountryGermany
    B.5.4Telephone number004973140008411
    B.5.5Fax number004973140008429
    B.5.6E-mailhvoneick@ctifacts.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 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.3.9.1CAS 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 typenot less then
    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
    I5NP is being developed for the prophylaxis of delayed graft function (DGF) 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. 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 13.1
    E.1.2Level LLT
    E.1.2Classification code 10048747
    E.1.2Term Renal graft function delayed
    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
    Part B portion:
    To determine the safety of I5NP when administered as a single intravenous push (IVP) to patients undergoing deceased donor kidney transplant.
    To assess the efficacy of I5NP in the prevention of delayed graft function (DGF) in patients at increased risk of DGF following deceased donor renal transplantation
    E.2.2Secondary objectives of the trial
    To determine the dose(s) of I5NP to be studied in subsequent trials.
    To prospectively determine the feasibility and validity of additional efficacy endpoints in this study population.
    To inform the design of subsequent trials.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Part B (the subject trial portion):
    1. Patient is at least 18 years of age.
    2. Patient has given informed consent.
    3. Patient is willing to practice birth control. Female / Male
    4. Women of childbearing potential test negative for pregnancy (either urine or serum) within 48 hours prior to transplant.
    5. Patient is up-to-date on cancer screening according to site-specific guidelines and the past medical history is negative for biopsy-confirmed malignancy within 5 years of randomization, with the exception of adequately treated basal cell or squamous cell carcinoma in situ.
    6. Patient is scheduled to receive kidney transplant from a deceased donor meeting the following criteria
    Part B exclusive:
    • Receipt of an ECD kidney that has been preserved by cold storage (ECD/CS) for the entire period of cold ischemia time (CIT)*, regardless of duration
    • Receipt of an ECD kidney that has been preserved by machine perfusion (ECD/MP**) for any interval of time during the period of cold ischemia, where total CIT* has been at least 26 hours
    • Receipt of an SCD kidney that has been preserved by cold storage (SCD/CS) where total CIT* has been at least 26 hours
    • Receipt of an SCD kidney that has been preserved by machine perfusion (SCD/MP**) for any interval of time during the period of cold ischemia, where total CIT* has been at least 26 hours.
    ________________________
    * CIT will be estimated at screening based on the difference between the time of aortic cross-clamping in the donor and projected initiation of the arterial anastomotic procedure in the recipient)
    ** For purposes of this study, a “kidney that has been preserved by machine perfusion” means that the kidney has had any machine preservation (e.g. a kidney that was initially machine perfused but then removed from the pump and placed on cold storage, would be considered MP).

    7. Patient is dialysis dependent at the time of transplant as documented by at least one of the following:
    • the requirement for at least 2 dialysis sessions/week during the 56 days prior to transplant, or
    • the planned removal of any remaining native kidney at the time of transplant, or
    • the investigator has provided documentation to the Medical Monitor that the patient has no remaining native renal function (e.g., documentation that the patient is anuric, with urine output <50 mL/day)
    E.4Principal exclusion criteria
    1. Patient has participated in an investigational drug study in the last 30 days.
    2. Patient has known allergy or has participated in prior study with siRNA.
    3. Patient is HCV-positive
    4. Patient is HIV-positive
    5. Patient is scheduled to undergo multiorgan transplantation.
    6. Patient has a planned transplant of kidneys that are implanted en bloc (dual kidney transplant).
    7. Patient has planned transplant of kidneys from donors < 6 years of age.
    8. Patient has planned transplant of dual kidneys (from the same donor) transplanted not en bloc (as in the case of dual ECD donor kidneys).
    9. Patient is scheduled for transplantation of a kidney from a donor who is known to have received an investigational therapy (under another IND) for ischemic/reperfusion injury immediately prior to organ recovery.
    10. Patient is scheduled to receive a living donor kidney.
    11. Patient is scheduled to receive an ABO-incompatible donor kidney.
    12. Patient is scheduled to receive an organ from a donor that meets both DCD and ECD criteria[1].
    13. Patient is scheduled to receive an organ from a donor that meets DCD criteria (exclusion applicable to Part B only)
    14. Patient has history or presence of a medical condition or disease that in the investigator’s assessment would place the patient at an unacceptable risk for study participation.

    ___________________________________
    [1] ECD is defined as deceased donors 60 years of age or donors 50-59 years of age with at least two of the following: history of hypertension (HTN), death due to cerebrovascular accident (CVA) or terminal serum creatinine (SCr) >1.5 mg/dL.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for Part B will be the incidence of DGF in the Intention-to-Treat (ITT) population of all randomized and transplanted patients, where DGF is defined as the need for acute dialysis within the first 7 days post-transplant excluding the following:
    • Dialysis performed during the first 24 hours for one or more of the following reasons:
    - Treatment of hyperkalemia or hypervolemia
    - Hyperacute rejection or other antibody-mediated acute rejection[1]
    - Technical vascular complications involving the allograft: renal arterial and/or venous thrombosis due to vascular injury or technical surgical complications.
    • Dialysis performed during the first 7 days post-transplant for one or more of the following reasons:
    - Obstructive uropathy[2]
    - Fulminant recurrence of primary disease (underlying etiology of ESRD)[1], including focal segmental glomerulosclerosis
    - A specific diagnosis of thrombotic microangiopathy (Thrombotic Thrombocytopenic Purpura or Hemolytic–Uremic Syndrome).[1]
    ___________________________________
    [1] Biopsy-confirmed
    [2] Radiographically-confirmed
    E.5.1.1Timepoint(s) of evaluation of this end point
    7 days post-transplant
    E.5.2Secondary end point(s)
    1. Need for dialysis for any reason within 7 days post-transplant
    2. Treatment difference in the need for dialysis within 7 days post-transplant for:
    a. Donor kidneys preserved using machine perfusion at any time pre-transplant
    b. Donor kidneys not preserved using machine perfusion at any time pre-transplant
    3. Treatment difference in the absence of a decrease in the serum creatinine concentration of at least 10%/day for at least 3 consecutive days during the first week post-transplantation.
    4. Treatment differences in the mean change from the pre-dose, post-reperfusion baseline serum creatinine and serum creatinine concentration at 24, 48, and 72 hours.
    5. Treatment difference in the rate of change in renal function as determined from the slope of the plot of serum creatinine versus time at 6, 12, 24, 36, 48, 72, 96, and 120 hours post-transplant.
    6. Treatment difference in the rate of change in renal function as determined from the slope of the plot of estimated GFR [eGFR - mL/min/1.73 m2, as determined from the (a) 4-variable MDRD equation and (b) Cockcroft-Gault equation after adjustment per 1.73 m2 body surface area versus time at 6, 12, 24, 36, 48, 72, 96, and 120 hours post-transplant.
    7. Estimated GFR (standardized creatinine) as determined from the (a) 4-variable MDRD equation and (b) Cockcroft-Gault equation after adjustment per 1.73 m2 body surface area on days 1, 3, 7, 30, 90, and 180 post-transplant.
    E.5.2.1Timepoint(s) of evaluation of this end point
    days 1, 3, 7, 30, 90, and 180 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 Yes
    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 No
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Canada
    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 years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    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: 261
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 65
    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 state34
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 66
    F.4.2.2In the whole clinical trial 326
    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 Decision2011-02-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-01-26
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