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    Summary
    EudraCT Number:2021-000099-12
    Sponsor's Protocol Code Number:APHP180617
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-07-09
    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 ConcernedFrance - ANSM
    A.2EudraCT number2021-000099-12
    A.3Full title of the trial
    Dose-adjustment of enoxaparin by a bayesian pharmacological approach in pediatric renal transplant recipients
    Ajustement de dose de l’énoxaparine par une approche pharmacologique bayésienne chez les receveurs transplantés rénaux pédiatriques
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dose-adjustment of enoxaparin by a bayesian pharmacological approach in pediatric renal transplant recipients
    Ajustement de dose de l’énoxaparine par une approche pharmacologique bayésienne chez les receveurs transplantés rénaux pédiatriques
    A.3.2Name or abbreviated title of the trial where available
    OPTI-TREX
    OPTI-TREX
    A.4.1Sponsor's protocol code numberAPHP180617
    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 SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
    B.1.3.4CountryFrance
    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 supportDGOS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
    B.5.2Functional name of contact pointDRCI, Hôpital St Louis
    B.5.3 Address:
    B.5.3.1Street Address1 av. Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number33144 84 17 12
    B.5.5Fax number33144 84 17 01
    B.5.6E-mailalexandra.bruneau@aphp.fr
    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 Yes
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameEnoxaparin
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNENOXAPARIN SODIUM
    D.3.9.1CAS number 9041-08-1
    D.3.9.4EV Substance CodeSUB11933MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2000 to 10000
    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
    Allograft vascular thrombosis
    Thrombose vasculaire allogreffe
    E.1.1.1Medical condition in easily understood language
    Allograft vascular thrombosis
    Thrombose vasculaire allogreffe
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10072226
    E.1.2Term Renal vascular thrombosis
    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 optimize the dose of enoxaparin in order to achieve appropriate anti-Xa activity in pediatric renal transplantation.
    Optimiser la dose d’énoxaparine afin d’obtenir une activité anti-Xa appropriée en transplantation rénale pédiatrique.
    E.2.2Secondary objectives of the trial
    • To maintain target-range anti-Xa activity at all assessments during the first week of treatment
    • To assess the safety of this approach.
    • Maintenir l’activité anti-Xa cible lors de toutes les évaluations pendant la première semaine de traitement
    • Évaluer la sécurité de cette approche.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) pediatric renal transplant recipients
    2) aged > 2 years and <18 years
    3) with an indication for enoxaparin treatment in the first post-transplant week according to the local transplant team such as inherited or acquired thrombotic disorders (eg. but not exclusive protein C, protein S, and antithrombin III deficiency; factor V Leiden mutation (FV506Q), prothrombin mutation (G20210A), mutation in the MTHFR gene (C677T), and antiphospholipid antibodies (anticardiolipin antibodies and lupus anticoagulants), history of thrombosis, donor age < 2 years, recipient age < 5 years, cold ischemia time >24h, multiple renal vessels
    4) informed consent form signed by the legal guardian(s)
    5) affiliated to a health insurance system
    1) receveur d’une transplantation rénale
    2) âgé > 2 ans et <18 ans
    3) avec une indication, selon l’équipe locale de transplantation, d’un traitement par énoxaparine au cours de la première semaine post-transplantation telles que les thrombophilies héréditaires ou acquises (par ex. mais non exclusif: déficit en protéine C, protéine S et antithrombine III; mutation du facteur V Leiden (FV506Q), mutation du gène de la prothrombine (G20210A), mutation du gène MTHFR (C677T), et/ou anticorps antiphospholipides (anticorps anticardiolipine et anticoagulants lupus), antécédents de thrombose, âge du donneur <2 ans, âge du receveur <5 ans, temps d’ischémie froide >24h, vaisseaux rénaux multiples
    4) recueil du consentement signé du(des) représentant(s) légal(aux)
    5) affilié ou bénéficiaire d’une sécurité sociale
    E.4Principal exclusion criteria
    1) per-transplant technical surgical problems
    2) pre-inclusion allograft thrombosis (before randomization and enoxaparin administration)
    3) peri-operative thrombosis or bleeding (before randomization and enoxaparin administration)
    4) peri-operative hemodynamic instability
    5) medical history of heparin-induced thrombocytopenia
    6) allergic reaction to enoxaparin or excipients
    7) pregnancy
    8) LMWH prophylactic before transplant
    1) problèmes chirurgicaux techniques pré-greffe
    2) thrombose du greffon avant inclusion (avant randomisation et administration de l’enoxaparine)
    3) thrombose ou saignement péri-opératoire (avant randomisation et administration de l’enoxaparine)
    4) instabilité hémodynamique péri-opératoire
    5) antécédents de thrombopénie induite par l’héparine
    6) hypersensibilité à l’enoxaparine ou à l’un des excipients
    7) grossesse
    8) HBPM en prophylactique avant greffe
    E.5 End points
    E.5.1Primary end point(s)
    Anti-Xa activity within target ranges (0.3-0.5 IU/mL) 28-30 hours after initiation of treatment.
    Activité anti-Xa dans les cibles (0,3 à 0,5 UI/mL) 28 à 30 heures après le début du traitement.
    E.5.1.1Timepoint(s) of evaluation of this end point
    28-30 hours after initiation of treatment
    28 à 30 heures après le début du traitement
    E.5.2Secondary end point(s)
    • Time to achieve a target anti-Xa activity (0.3-0.5 IU/mL)
    • Anti-Xa activity within target ranges from H28-30 to D7 after initiation of treatment (same method as primary endpoint)
    • Graft thrombosis : assessed by allograft ultrasound
    • Enoxaparin-related side effects during the first postoperative month: bleeding (all localisations), graft hematoma (presence/absence): assessed by ultrasound
    • Allograft bleeding: bleeding with post-operative transfusion
    • Enoxaparin induced thrombopenia
    • Temps nécessaire pour atteindre une activité anti-Xa cible (0,3 à 0,5 UI/mL)
    • Activité anti-Xa dans les cibles allant de H28-30 à D7 après le début du traitement
    • Thrombose artérielle et ou veineuse du greffon
    • Effets secondaires liés à l’énoxaparine au cours du premier mois postopératoire : saignement (toutes localisations), hématome du greffon (présence/absence)
    • Saignement du greffon: saignement nécessitant ou non une transfusion post-opératoire
    • Thrombopénie induite par l’énoxaparine
    E.5.2.1Timepoint(s) of evaluation of this end point
    - H28-30 to D7 after initiation of treatment
    - D30
    - H28-30 à J7 après le début du traitement
    - J30
    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 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 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) 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 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 Yes
    E.8.2.3.1Comparator description
    Ajustement de dose empirique
    Empirical dose adjustment
    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 concerned9
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 months24
    E.8.9.1In the Member State concerned days30
    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: 50
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 25
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 25
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    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)
    None
    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 Decision2021-10-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-08-28
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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