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    Summary
    EudraCT Number:2015-003995-65
    Sponsor's Protocol Code Number:TAKICARD-1
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-09-24
    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 ConcernedSweden - MPA
    A.2EudraCT number2015-003995-65
    A.3Full title of the trial
    Pharmacokinetics of ANP, a diuretic hormone, in neonates undergoing surgery for congenital heart defects. A pilot study.
    Hur omsätts det urindrivande medlet ANP i kroppen hos nyfödda som opereras för medfödda hjärtfel? En pilotstudie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pharmacokinetics of ANP, a diuretic hormone, in newborns undergoing surgery for congenital heart defects? A pilot study.
    Hur omsätts det urindrivande medlet ANP i kroppen hos nyfödda som opereras för medfödda hjärtfel? En pilotstudie.
    A.3.2Name or abbreviated title of the trial where available
    Pharmacokinetics of ANP in newborns
    Omsättning av ANP i blod hos nyfödda
    A.4.1Sponsor's protocol code numberTAKICARD-1
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorVästra Götalandsregionen, Sahlgrenska University Hospital /Queen Silvia children's hospital
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportVästra Götalandsregionen, Sahlgrenska University Hospital /Queen Silvia children's hospital
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSahlgrenska University Hospital /Queen Silvia children's hospital
    B.5.2Functional name of contact pointAnOpIVA
    B.5.3 Address:
    B.5.3.1Street AddressRondvägen 10, AnOpIVA, Plan 7
    B.5.3.2Town/ cityGöteborg
    B.5.3.3Post code416 85
    B.5.3.4CountrySweden
    B.5.4Telephone number+46(0)31343 45 28
    B.5.6E-mailalbert.castellheim@gu.se
    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.2.1.1.1Trade name HANP® Injection 1000
    D.2.1.2Country which granted the Marketing AuthorisationJapan
    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 nameHANP i.v. infusion
    D.3.4Pharmaceutical form Powder for solution for injection/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 INNCARPERITIDE
    D.3.9.1CAS number 89213-87-6
    D.3.9.4EV Substance CodeSUB06139MIG
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute renal failure after heart surgery
    Akut njursvikt efter hjärtkirurgi
    E.1.1.1Medical condition in easily understood language
    Acute renal failure
    Akut njursvikt
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10038447
    E.1.2Term Renal failure neonatal
    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 investigate the metabolism of hANP routinely given to newborn babies who develop acute renal failure associated with cardiac surgery.
    Att undersöka omsättningen i kroppen av läkemedlet hANP som rutinmässigt ges till nyfödda barn som utvecklar akut njursvikt i samband med hjärtkirurgi.
    E.2.2Secondary objectives of the trial
    Not applicable
    Ej tillämpligt
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Children undergoing corrective heart surgery
    2. Who develope acute renal failure
    3. Will be treated with hANP
    4. Age 1-12 months,
    5. Dual-chamber physiology
    6. Informed consent by parents/guardians
    1. Barn som genomgått korrigerande kirurgi för medfödda hjärtfel
    2. Utvecklat akut njursvikt
    3. Skall behandlas med hANP
    4. Ålder 1-12 månader
    5. Tvåkammarfysiologi
    6. Signerat informerat samtycke från föräldrar/vårdnadshavare


    E.4Principal exclusion criteria
    Not applicable
    Ej tillämpligt
    E.5 End points
    E.5.1Primary end point(s)
    Area under the curve (AUC), maximum concentration (Cmax), time to Cmax, clearance (CL), volume of distribution (Vd), half-life (t1 / 2) and mean residence time (MRT) and compartment modeling and physiological modeling.
    Area under curve (AUC), högsta koncentrationen (Cmax), tid till Cmax, clearance (CL), distributionsvolym (Vd), halveringstid (t1/2), mean residence time (MRT) samt compartment modeling och fysiologisk modeling.
    E.5.1.1Timepoint(s) of evaluation of this end point
    T0 = Before starting treatment
    T1 = 1 hour after the start of treatment
    T2 = 2 hours after the start of treatment
    T4 = 4 hours after start
    T8 = 8 hours after start
    T16 = 16 hours after start
    T24 = 24 hours after start
    T32 = 32 hours after starting treatment
    T -1 = 1 hour before release
    T + 1 = 1 hour after release
    T0 = Innan behandlingsstart
    T1 = 1 timme efter behandlingsstart
    T2 = 2 timmar efter behandlingsstart
    T4 = 4 timmar efter behandlingsstart
    T8 = 8 timmar efter behandlingsstart
    T16 = 16 timmar efter behandlingsstart
    T24 = 24 timmar efter behandlingsstart
    T32 = 32 timmar efter behandlingsstart
    T -1 = 1 timme innan utsättning
    T +1 = 1 timme efter utsättning
    E.5.2Secondary end point(s)
    Not applicable
    Ej tillämpligt
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    Ej tillämpligt
    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 No
    E.6.4Safety No
    E.6.5Efficacy No
    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.6.13.1Other scope of the trial description
    Denna explorativa pilotstudie syftar till att ge en orienterande bild av farmakologiska parametrar hos aktuell patientgrupp inför planering av framtida kliniska studier.
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Pharmacokinetics
    Orienterande farmakokinetik
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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 study is defined as the last blood sample, i.e. 1 hour after the ANP discontinuation
    Studien definieras som avslutad efter sista blodprovet dvs. 1 timme efter ANP-behandlingens utsättande
    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 months
    E.8.9.1In the Member State concerned days7
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 10
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 10
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients under 12 months of age
    Patienter är mindre än 12 månader gamla
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    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)
    Patients are treated in the children's post-surgery intensive care unit according to the routine for this type of surgery and condition as long as medically indicated
    Patienterna behandlas på barn-IVA enligt rutin för denna typ av operation och tillstånd och under den tid som är medicinskt motiverat.
    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 Decision2015-11-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-15
    P. End of Trial
    P.End of Trial StatusOngoing
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