Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43853   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2010-020989-20
    Sponsor's Protocol Code Number:QRK.006PartB
    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:2011-01-07
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2010-020989-20
    A.3Full title of the trial
    Estudio controlado, aleatorizado, prospectivo, doble ciego, multicéntrico, fase I/II, con escalada de dosis, de seguridad, farmacocinética y actividad clínica de I5NP para la profilaxis de la función retardada del injerto en pacientes trasplantados de riñón de donante cadáver
    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.006PartB
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    IN5P se está desarrollando para la profilaxis de la función retardada del injerto (DGF) en pacientes que reciben trasplantes renales. La población de este estudio incluirá pacientes que se sometan a trasplante renal de donante cadáver con riesgo de padecer DGF.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10048747
    E.1.2Term Renal graft function delayed
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Parte B:
    -Determinar la seguridad de I5NP cuando se administra como una única dosis en bolo intravenosa (IVP) a pacientes que se someten a trasplante de riñón de donante
    cadáver.
    -Evaluar la eficacia de I5NP en la prevención de DGF en pacientes con riesgo aumentado de DGF tras
    trasplante renal de donante cadáver.
    E.2.2Secondary objectives of the trial
    Determinar la(s) dosis de I5NP que debe(n) estudiarse en ensayos posteriores.
    Determinar prospectivamente la viabilidad y validez de variables de eficacia adicionales en esta población
    de estudio.
    Informar del diseño de ensayos posteriores.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -El paciente tiene programado recibir trasplante de rinon de un donante cadaver que cumple los siguientes criterios:
    --receptor de un rinon con ECD que se ha conservado mediante almacenamiento en frio (ECD/CS) durante todo el periodo de tiempo de isquemia fria (CIT)*, independientemente de la duracion
    --receptor de un rinon con ECD que se ha conservado mediante perfusion con maquina (ECD/MP) durante cualquier intervalo de tiempo durante el periodo de isquemia fria, en el que el CIT total ha sido de al menos 26 horas
    --receptor de un rinon con SCD que se ha conservado mediante almacenamiento en frio (SCD/CS) en el que el CIT total ha sido de al menos 26 horas
    --receptor de un rinon con SCD que se ha conservado mediante perfusion con maquina (SCD/MP) durante cualquier intervalo de tiempo durante el periodo de isquemia fria, en el que el CIT* total ha sido de al menos 26 horas.

    -El paciente es dependiente de diálisis en el momento del trasplante y consta documentado por presentar, al menos, una de las siguientes situaciones:
    --el requisito de al menos 2 sesiones de diálisis/semana durante los 56 días antes del trasplante hasta el trasplante, o
    --la extracción planeada de cualquier riñón nativo restante en el momento del trasplante, o
    --la opinión del investigador de que el paciente no tiene función renal nativa residual (sólo parte A)
    --el investigador ha proporcionado documentación al Monitor Médico de que el paciente no tiene función renal nativa residual (por ejemplo, documentación de que el paciente es anúrico, con producción de orina <50 mL/día).
    E.4Principal exclusion criteria
    -El paciente tiene programado someterse a trasplante multiorgánico.
    -El paciente tiene programado un trasplante de riñones implantados en bloque (trasplante de riñón doble).
    -El paciente tiene planeado un trasplante de riñones de donantes < 6 años de edad.
    -El paciente tiene planeado un trasplante de riñones doble (del mismo donante) no trasplantados en bloque (como en el caso de riñones de donante ECD doble).
    -El paciente tiene programado un trasplante de un riñón de un donante que se sabe que ha recibido una terapia en investigación (con otro IND) para lesión isquémica/por reperfusión inmediatamente antes de la recuperación del órgano.
    -El paciente tiene programado recibir un riñón de donante vivo.
    -El paciente tiene programado recibir un riñón de donante incompatible para ABO.
    -El paciente tiene programado recibir un órgano de un donante que cumple los criterios tanto de DCD como de ECD.
    -El paciente tiene programado recibir un órgano de un donante que cumple los criterios de DCD.
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal para la parte B será la incidencia de DGF en la población de intención de tratar (ITT) de todos los pacientes aleatorizados y sometidos a trasplante, en el que DGF se define como la necesidad de iniciar diálisis en el plazo de 7 días tras le trasplante, excluyendo lo siguiente:
    --Diálisis realizada durante las primeras 24 horas por uno o más de los siguientes motivos:
    Tratamiento de hiperpotasemia o hipervolemia
    Rechazo hiperagudo u otro rechazo agudo mediado por anticuerpos
    Complicaciones vasculares técnicas que afectan al aloinjerto: trombosis renal arterial y/o venosa
    --Diálisis realizada durante los primeros 7 días postrasplante por uno o más de los siguientes motivos:
    Uropatía obstructiva
    Recurrencia fulminante de enfermedad primaria (etiología subyacente de ESRD)1, incluyendo glomerulosclerosis segmentaria focal
    Un diagnóstico específico de microangiopatía trombótica (púrpura trombocitopénica trombótica o síndrome hemolítico-urémico)
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 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.8.3 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    El final del estudio será declarada cuando los datos de la última visita del último sujeto (LPLV) han sido incluidos en la base de datos.
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 66
    F.4.2.2In the whole clinical trial 326
    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 Decision2011-04-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-02-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Tue Apr 23 08:51:11 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA