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    Summary
    EudraCT Number:2012-005710-19
    Sponsor's Protocol Code Number:M13-958
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-10-28
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2012-005710-19
    A.3Full title of the trial
    A Phase 2b, Randomized, Double-Blind,
    Placebo-Controlled, Safety and Efficacy Trial of
    Multiple Dosing Regimens of ABT-719 for the
    Prevention of Acute Kidney Injury in Subjects
    Undergoing High Risk Major Surgery
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2b, Randomized, Double-Blind,
    Placebo-Controlled, Safety and Efficacy Trial of
    Multiple Dosing Regimens of ABT-719 for the
    Prevention of Acute Kidney Injury in Subjects
    Undergoing High Risk Major Surgery
    A.4.1Sponsor's protocol code numberM13-958
    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 SponsorAbbVie Deutschland GmbH & Co. KG
    B.1.3.4CountryGermany
    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 supportAbbVie Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbVie Ltd.
    B.5.2Functional name of contact pointEU Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbott House, Vanwall Business Park,
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4XE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441628644475
    B.5.5Fax number+441628644330
    B.5.6E-maileu-clinical-trials@abbvie.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 nameABT-719
    D.3.2Product code ABT-719
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNABT-719
    D.3.9.2Current sponsor codeABT-719
    D.3.9.3Other descriptive nameABT-719
    D.3.9.4EV Substance CodeSUB116484
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 No
    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 infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute Kidney Injury
    E.1.1.1Medical condition in easily understood language
    Acute Kidney Injury
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10069339
    E.1.2Term Acute kidney injury
    E.1.2System Organ Class 100000004857
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To determine the safety and pharmacokinetics of 800 mcg/kg intravenous (IV) infusions of
    ABT-719 in the first 6 subjects enrolled who are at risk of acute kidney injury (AKI) and undergoing
    high risk major surgery.
    -To compare the safety and efficacy of doses of 800 mcg/kg, 1600 mcg/kg and 2100 mcg/kg
    IV infusions of ABT-719 to placebo in subjects who are at risk of AKI and undergoing high risk major
    surgery.
    E.2.2Secondary objectives of the trial
    not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject must be male or female, age >= 18 years old
    2. Subject undergoing open aortic surgery or open surgery of the renal artery
    or
    Subject undergoing surgery (vascular surgery, endovascular surgery, non-CPB cardiac surgery or transcatheter aortic valve replacement (TAVR)) of anticipated duration of > =2 hours with a least one of the follwing:
    a. eGFR > 15 mL/min/1.73 m2 to < 60 mL/min/1.73 m2 as determined by CKD EPI formula at Screening, OR
    b. Subject is Type 1 or 2 diabetic requiring anti-diabetic medication (oral or insulin), OR
    c. Subject has documented history of proteinuria > 0.3 g/day (spot urine protein/creatinine ratio [UPCR] >= 0.3 g/g or urine dip stick 2+ or more evaluated at screening
    E.4Principal exclusion criteria
    1. Active peptic ulcer disease with history of upper GI bleed.
    2. Has ongoing sepsis or history of sepsis within the last 2 weeks or
    untreated diagnosed infection prior to Screening visit
    3. Has known/documented history of RIFLE or AKIN within the previous 4 weeks
    4. Subject with cancer and on active nephrotoxic chemotherapy (treatment), or have received (nephrotoxic chemotherapy in the previous 10 weeks), or are expecting to receive nephrotoxic chemotherapy in the next 3 months and/or life expectancy of 1 year or less
    E.5 End points
    E.5.1Primary end point(s)
    The maximal change from baseline in urine NGAL until Day 7 or discharge.
    E.5.1.1Timepoint(s) of evaluation of this end point
    90 days
    E.5.2Secondary end point(s)
    • Maximal change from baseline in urine and plasma AKI biomarkers (excluding urine NGAL) through Day 7 or discharge.
    • Proportion of subjects developing AKI as defined by the AKIN scoring criteria (Stage 1, Stage 2, or Stage 3).
    • Proportion of subjects developing at least one of the composite events: death, needing RRT during the 90-day post-operative period, or having a ≥ 25% reduction in SCr based eGFR or measured GFR at Day 90 post-surgery visit
    • Proportion of subjects developing at least one of the composite events: death, needing RRT during the 60-day post-operative period, or having a ≥ 25% reduction in SCr based eGFR or measured GFR at Day 60 post-surgery visit
    • Proportion of subjects developing at least one of the composite events: death, needing RRT during the 90-day post-operative period, or having a ≥ 25% reduction in S-Cystatin C based eGFR or measured GFR at Day 90 post-surgery visit
    • Proportion of subjects developing at least one of the composite events: death, needing RRT during the 60-day post-operative period, or having a ≥ 25% reduction in S-Cystatin C based eGFR or measured GFR at Day 60 post-surgery visit
    • Proportion of subjects developing AKI as defined by the RIFLE scoring criteria (Risk, Injury, Failure, Loss or ESRD)
    • Proportion of subjects developing AKI as defined by the KDIGO scoring criteria (Stage 1, Stage 2 or Stage 3)
    • Changes from baseline in serum creatinine (SCr) and S-Cystatin C at all study visits from Day 0 to Day 90
    • Maximal change from baseline in SCr and S-Cystatin C until Day 7 or until discharge from the hospital
    • Changes from baseline in SCr based eGFR, S-Cystatin C based eGFR and measured GFR at all study visits from Day 0 to Day 90
    • Changes from baseline in AKI Biomarkers (urine and serum) at all study visits from Day 0 to Day 90
    • Number of hospitalizations and days hospitalized during the 90-day post-operative period
    • EQ-5D endpoints:
    o The treatment group differences in change from baseline to each post baseline measure for EQ 5D index and VAS scores
    o The differences in change from baseline to each post-baseline measure for EQ-5D index and VAS scores in subjects with postoperative AKI compared to those without AKI
    o Proportion of subjects in each treatment group and disease state groups who experience 'no problem' (level 1) and 'problems' (level 2 and 3) in 5 dimensions of EQ-5D
    E.5.2.1Timepoint(s) of evaluation of this end point
    90 days
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 trial4
    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 concerned5
    E.8.5The trial involves multiple Member States No
    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
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months11
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 340
    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 75
    F.4.2.2In the whole clinical trial 240
    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)
    standard of care
    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 Decision2013-10-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2014-04-08
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