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    Summary
    EudraCT Number:2010-019630-28
    Sponsor's Protocol Code Number:C10-001
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-01-30
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2010-019630-28
    A.3Full title of the trial
    A RANDOMIZED, OPEN-LABEL, MULTICENTER TRIAL TO DETERMINE SAFETY AND EFFICACY OF ECULIZUMAB IN THE PREVENTION OF ANTIBODY MEDIATED REJECTION (AMR) IN LIVING DONOR KIDNEY TRANSPLANT RECIPIENTS REQUIRING DESENSITIZATION THERAPY
    ENSAYO ALEATORIZADO, ABIERTO, MULTICÉNTRICO PARA DETERMINAR LA SEGURIDAD Y EFICACIA DE ECULIZUMAB EN LA PREVENCIÓN DEL RECHAZO MEDIADO POR ANTICUERPOS (RMA) EN RECEPTORES DE TRASPLANTE RENAL DE DONANTE VIVO QUE REQUIEREN TERAPIA DE DESENSIBILIZACIÓN
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    OPEN LABEL CONTROLLED TRIAL OF ECULIZUMAB IN THE PREVENTION OF AMR IN LIVING DONOR KIDNEY TRANSPLANT RECIPIENTS REQUIRING DESENSITIZATION
    ENSAYO ABIERTO DE ECULIZUMAB EN LA PREVENCIÓN DEL RMA EN RECEPTORES DE TRASPLANTE DE RIÑÓN DE DONANTES VIVOS QUE NECESITAN TRATAMIENTO DE DESENSIBILIZACIÓN
    A.4.1Sponsor's protocol code numberC10-001
    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 SponsorAlexion 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 supportALEXION PHARMACEUTICALS INC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationALEXION EUROPE SAS
    B.5.2Functional name of contact pointEuropean Clinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address25 boulevard de l'Amiral Bruix
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75016
    B.5.3.4CountryFrance
    B.5.4Telephone number+ 33153643848
    B.5.5Fax number+ 33153643820
    B.5.6E-mailclinicaltrials.eu@alxn.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 Yes
    D.2.1.1.1Trade name SOLIRIS
    D.2.1.1.2Name of the Marketing Authorisation holderALEXION EUROPE SAS
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Concentrate for 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 INNECULIZUMAB
    D.3.9.1CAS number 219685-50-4
    D.3.9.2Current sponsor codeh5G1.1-mAb
    D.3.9.3Other descriptive nameAnti-C5 antibody
    D.3.9.4EV Substance CodeSUB25187
    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 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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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 typemonoclonal antibody
    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
    Antiobdy mediated rejection after kidney transplant
    RECHAZO MEDIADO POR ANTICUERPOS EN RECEPTORES DE TRASPLANTE DE RIÑON
    E.1.1.1Medical condition in easily understood language
    Kidney transplant rejection
    RECHAZO TRASPLANTE DE RIÑON
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10064683
    E.1.2Term Antibody-mediated rejection
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety and efficacy of eculizumab in the prevention of antibody mediated rejection (AMR) in living donor kidney recipients requiring desensitization therapy
    Evaluar la seguridad y la eficacia de eculizumab en la prevención del Rechazo Mediado Por Anticuerpos (RMA) en receptores de trasplantes renales de donantes vivos que requieren terapia de desensibilización
    E.2.2Secondary objectives of the trial
    Safety and Efficacy
    La seguridad y la eficacia
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female patients ≥ 18 years old
    - Patients with Stage IV or Stage V chronic kidney disease who will receive a kidney transplant from a living donor to whom they are sensitized and require desensitization prior to transplantation
    - Patients must be willing and able to give written informed consent
    -Pacientes, hombres o mujeres, ≥ 18 años
    -Pacientes con enfermedad renal crónica en estadio IV o V que recibirán un trasplante de riñón de un donante vivo para el que son sensibles y requieren una terapia de desensibilización antes del trasplante
    - Los pacientes deben estar dispuestos y ser capaces de dar su consentimiento informado por escrito
    E.4Principal exclusion criteria
    - Has received treatment with eculizumab at any time prior to enrolling in this study
    - ABO incompatible with living donor
    - Haber recibido tratamiento con eculizumab en cualquier momento antes de su inclusion en este estudio
    - ABO incompatible con el donante vivo
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the safety and efficacy of eculizumab to prevent AMR in sensitized recipients of living donor kidney transplants requiring desensitization therapy.
    Evaluar la seguridad y la eficacia de eculizumab en la prevención del Rechazo Mediado Por Anticuerpos (RMA) en receptores de trasplantes renales de donantes vivos que requieren terapia de desensibilización.
    E.5.1.1Timepoint(s) of evaluation of this end point
    9 weeks
    9 semanas
    E.5.2Secondary end point(s)
    Cumulative incidence of AMR that occur between week 9 and month 12 post-transplantation.
    Incidencia acumulada del Rechazo Mediado Por Anticuerpos (RMA) que se produce entre la semana 9 y el mes 12 tras el trasplante
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 year
    un año
    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 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    SOC
    E.8.2.4Number of treatment arms in the trial2
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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
    Australia
    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
    last visit of the last patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 months6
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 0
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 80
    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)
    Not different from the expected normal treatment of that condition
    No difiere del tratamiento normal esperado para esta condicion
    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 Decision2012-03-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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