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   43871   clinical trials with a EudraCT protocol, of which   7290   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:2007-000229-23
    Sponsor's Protocol Code Number:DGD 44-044
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-12-20
    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 number2007-000229-23
    A.3Full title of the trial
    EVALUACIÓN DE LA SEGURIDAD RENAL TRAS ARM POTENCIADA CON DOTAREM EN COMPARACIÓN CON LA RM SIN CONTRASTE ENTRE PACIENTES CON ALTO RIESGO DE PADECER NEFROPATIA PROVOCADA POR EL MEDIO DE CONTRASTE

    RENAL SAFETY EVALUATION AFTER DOTAREM-ENHANCED MRA COMPARED WITH NON-ENHANCED MRI IN PATIENTS AT HIGH RISK OF DEVELOPING CONTRAST MEDIUM INDUCED NEPHROPATHY.
    A.3.2Name or abbreviated title of the trial where available
    RESCUE
    A.4.1Sponsor's protocol code numberDGD 44-044
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) Numbernot applicable
    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 SponsorGUERBET
    B.1.3.4CountryFrance
    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 Yes
    D.2.1.1.1Trade name DOTAREM 0.5 mmol/ml solución inyectable
    D.2.1.1.2Name of the Marketing Authorisation holderCODALI
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameDOTAREM 0.5mmol/ml solución inyectable
    D.3.2Product code Not applicable
    D.3.4Pharmaceutical form Solution for 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.3.8INN - Proposed INNGadoteric Acid (Acido gadotérico en forma de gadoterato de meglumina)
    D.3.9.3Other descriptive name1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetic acid, Gadolinium complex
    D.3.10 Strength
    D.3.10.1Concentration unit mmol/ml millimole(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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 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
    Pacientes con insuficiencia renal y programada una angiografia por RM realzada con contraste o RM sin realce.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 10.0
    E.1.2Level LLT
    E.1.2Classification code 10038474
    E.1.2Term <Manually entered code. Term in E.1.1>
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar, entre pacientes de riesgo (aquejados al menos de insuficiencia renal moderada) la frecuencia de la nefropatía provocada por contraste tras someterse a ARM realzada con Dotarem, en comparación con la frecuencia de la nefropatía tras una RM sin realce, y observar la equivalencia entre ambos procedimientos con respecto a dichas frecuencias.
    E.2.2Secondary objectives of the trial
    Confirmar la seguridad clínica y biológica de DOTAREM® mediante la evaluación de las constantes vitales, las variables analíticas y los acontecimientos adversos hasta las 72±12h tras el tratamiento o período de seguimiento posterior a la exploración.
    Evaluar la fluctuación de las concentraciones séricas de creatinina en términos de la diferencia media entre el valor basal y las 72±12h tras la exploración.
    Evaluar la fluctuación de la filtración glomerular estimada en términos de porcentaje y diferencia media entre el valor basal y las 72±12h tras la exploración. La FG estimada se calculará mediante la ecuación del estudio MDRD.
    Si resulta viable, evaluar la posible influencia del protocolo de hidratación o del tratamiento profiláctico sobre la función renal.
    Si al cabo de 72±12h se produce un incremento de la creatinina sérica de al menos un 25 % o de 0,5 mg/dl, observar el porcentaje de pacientes que recuperan el valor basal al cabo de 14 días de la última extracción sanguínea.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Varones o mujeres de edad >= 55 años.
    -Insuficiencia renal conocida y estable en fase III o IV según la definición de la K/DOQI, es decir 15 < FG estimada < 60 ml/min/1,73 m² según la fórmula del MDRD en dos valores consecutivos (que no varíen más de un 10 % el uno del otro) entre los que medie al menos una semana y siempre que el más reciente corresponda a las 24 horas previas al procedimiento del estudio.
    -Programación de una angiorresonancia magnética o una resonancia magnética sin realce para elaborar un diagnóstico.
    -Capacidad de comprender y de prestar el consentimiento informado por escrito para participar en el ensayo.
    -Posibilidad de aportar muestras de sangre en las 24 horas previas a la prueba y en las 72 horas posteriores.
    E.4Principal exclusion criteria
    ·Contraindicación a la RM (p. ej.: marcapasos, clip para aneurisma, claustrofobia grave, prótesis articulares de metal u otros factores, según la práctica del laboratorio).
    ·Diagnóstico de inestabilidad hemodinámica (choque cardiogénico: presión sistólica persistente < 90 que requiere tratamiento inotrópico) o infarto agudo de miocardio en los 15 días previos a la inclusión.
    ·Necesidad de hemodiálisis.
    ·Alergia conocida a los quelatos de gadolinio (criterio válido sólo para los pacientes sometidos a ARM realzada con Dotarem).
    ·Tratamiento con medicamentos de conocido efecto nefrotóxico o que aumenten las concentraciones séricas de creatinina (es decir, inhibidores selectivos de la ciclooxigenasa 2, antagonistas del factor de crecimiento endotelial vascular, vancomicina, aciclovir, aminoglucósidos, amfotericina B, polimixina, complejos de platino y antiinflamatorios no esteroideos salvo el ácido acetilsalicílico) en las 2 semanas previas a la primera extracción sanguínea y durante las 72 horas siguientes a la exploración.
    ·Modificación de la pauta posológica de los diuréticos en el mes anterior a la inclusión o previsión de modificación durante los 3 días siguientes a la exploración.
    ·Programación de intervención quirúrgica o quimioterapia en las 72 horas siguientes a la exploración (es decir: antes de la extracción sanguínea de las 72 horas después).
    ·Haberse sometido a una prueba de diagnóstico por la imagen (con medio de contraste o no) en los 7 días previos a la inclusión en el presente protocolo.
    ·Programación de una prueba de diagnóstico por la imagen (con medio de contraste o no) en las 72 horas siguientes a la exploración.
    ·Diabetes inestable de diagnóstico reciente.
    E.5 End points
    E.5.1Primary end point(s)
    La evaluación de la tolerancia renal tras los dos procedimientos (RM y ARM realzada con DOTAREM® se realizará determinando las concentraciones séricas de creatinina a partir de una muestra de sangre obtenida en las 24 horas previas a la prueba de imagen y una muestra obtenida al cabo de 72 ± 12 horas de su realización.

    El estudio calculará en los dos grupos el porcentaje de pacientes con un aumento significativo de la concentración sérica de creatinina según el método que se describe a continuación.
    Por aumento significativo de la concentración de creatinina (nefrotoxicidad) se entenderá un incremento de la concentración sérica de creatinina al cabo de 72 ± 12 horas de al menos el 25 % o de 0,5 mg/dl (= 44,2 µmol/l) con respecto al valor basal.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    comparative descriptive
    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
    El comparador será un examen sin inyección de medio de contraste (MRI sin realce).
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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 Information not present in EudraCT
    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
    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 years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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.1.3Elderly (>=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 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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Pacientes con insuficiencia renal.
    F.4 Planned number of subjects to be included
    F.4.1In the member state42
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 134
    F.4.2.2In the whole clinical trial 134
    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)
    Las previsiones de tratamiento o cuidados médicos para los sujetosque han finalizado su participación en el ensayo no son diferentes de las esperadas en las condiciones sin tratamiento.
    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 Decision2008-03-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-12-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-05-09
    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-Mon May 06 06:55:44 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA