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    Summary
    EudraCT Number:2013-001229-15
    Sponsor's Protocol Code Number:PNIC-Na
    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:2013-06-26
    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 number2013-001229-15
    A.3Full title of the trial
    The efficacy of oral and intravenous administration of sodium chloride in the prophylaxis of nephropathy induced by iodinated contrasts in outpatients
    Eficacia de la administración de cloruro sódico oral e intravenoso en la profilaxis de la nefropatía inducida por contraste yodado en pacientes ambulantes
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The efficacy of oral administration of sodium chloride in the prophylaxis of nephropathy induced by iodinated contrasts
    Eficacia de la administración de sal común por vía oral para prevenir la nefropatía por contraste iodado
    A.4.1Sponsor's protocol code numberPNIC-Na
    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 SponsorFundación para la Investigación Biomédica del Hospital Universitario Ramón y Cajal
    B.1.3.4CountrySpain
    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 supportSanitary Ministery
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación para la Investigación Biomédica Hospital Ramón y Cajal
    B.5.2Functional name of contact pointFIBio
    B.5.3 Address:
    B.5.3.1Street AddressCtra Colmenar Viejo KM 9,100
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28034
    B.5.3.4CountrySpain
    B.5.4Telephone number34913368825
    B.5.5Fax number34913368825
    B.5.6E-mailipablo.hrca@gmail.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Sodium chloride solution 0.9% Baxter
    D.2.1.1.2Name of the Marketing Authorisation holder53064
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameSodium chloride solution 0.9% Baxter
    D.3.2Product code 53064
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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) 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
    Patients at high risk of developing an iodinated contrast-induced nephropathy.
    Pacientes con alto riesgo de desarrollar nefropatía por contraste
    E.1.1.1Medical condition in easily understood language
    Patients at high risk of developing kidney damage when performing a radiology test with contrast
    Pacientes con alto riesgo de desarrollar daño renal al realizarse una prueba radiológica con contraste
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Compare the incidence of nephropathy induced by iodinated contrasts (NIC) after the administration of oral sodium chloride in relation to intravenous risk outpatients
    Comparar la incidencia de NIC tras la administración de cloruro sódico por vía oral en relación con la vía intravenosa en pacientes ambulantes de alto riesgo.
    E.2.2Secondary objectives of the trial
    Study and assess the clinical utility of various biomarkers of NIC damage, both for early diagnosis of renal damage prior to stratification of risk of developing it.

    Develop in accordance with the results obtained a recommendation applicable to outpatients at high risk for NIC.
    Estudiar y valorar la utilidad clínica de diversos biomarcadores de daño en la NIC, tanto para el diagnóstico precoz del daño renal como para la estratificación previa del riesgo de desarrollarla.

    Elaborar en función de los resultados obtenidos una recomendación aplicable a pacientes ambulantes de alto riesgo de padecer NIC.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients will undergo performing contrast CT, as indicated by clinical practice, and after being informated, agree to participate and sign the written consent to participate in the study , and meet the following criteria:

    Age over 65 years

    One of the following risk factors for NIC: diabetes mellitus, stable heart failure or kidney failure (estimated glomerular filtration rate calculated by the MDRD-4 between 30 and 60 ml / min)
    Pacientes que vayan a ser sometidos a la realización de TAC con contraste, según indicación de práctica clínica, y que tras haber recibir información sobre el diseño, los fines del estudio, los posibles riesgos que de él pueden derivarse, y denegación de continuar en el estudio, otorguen por escrito su consentimiento para participar en el estudio y para la cesión de muestras biológicas y cumplan los siguientes criterios:

    Edad superior a 65 años

    Uno de los siguientes factores de riesgo de NIC: diabetes mellitus, insuficiencia cardiaca estable o insuficiencia renal (un filtrado glomerular estimado calculado por la fórmula MDRD-4 entre 30 y 60 ml/min)
    E.4Principal exclusion criteria
    Glomerular filtration rate below 30 ml / min.

    Presence of hypokalemia (serum potassium less than 3.5 mEq / L).
    Other procedures with intravenous contrast in the 15 previous days.

    Administration of nephrotoxic drugs (NSAIDs, aminoglycosides and / or potentially nephrotoxic chemotherapy) in the previous72 hours, or after the treatment.
    Filtrado glomerular inferior a 30 ml/min.

    Presencia de hipopotasemia (potasio sérico inferior a 3,5 mEq/L).

    Realización de otros procedimientos con contraste intravenoso en los quince días previos.

    Administración de nefrotóxicos (AINES, aminoglucósidos y/o quimioterápicos potencialmente nefrotóxicos) en las últimas 72 horas, o previsión de recibirlos en horas posteriores.

    Patología crónica descompensada: insuficiencia cardiaca aguda, EPOC descompensado o hipertensión arterial mal controlada.
    E.5 End points
    E.5.1Primary end point(s)
    NIC defined by the presence in the first 48 hours after administration of contrast, any of the following criteria, in the absence of other causes warrant:

    Increased serum creatinine greater than 0.3 mg / dl, compared to baseline.

    Reduction in glomerular filtration rate estimated by the MDRD formula (simply) more than 25% of baseline.
    Aparición de NIC definida por la presencia en las primeras 48 horas tras la administración del contraste, en ausencia de otras causas que lo justifiquen, de cualquiera de los siguientes criterios:

    Aumento de la creatinina sérica mayor de 0,3 mg/dl, con respecto a la basal.

    Reducción del filtrado glomerular estimado por la fórmula MDRD (forma sencilla) superior al 25 % del valor basal.
    E.5.1.1Timepoint(s) of evaluation of this end point
    48 hours
    48 horas
    E.5.2Secondary end point(s)
    Plasma Cystatin C,

    Serum ions

    Venous gas analysis.

    Serum MicroRNAs: microRNA101 * microRNA127 microRNA126 * and *.

    Urinary concentrations: NGAL *, * KIM-1, NAG *, t-gelsolin * GM2AP *, and creatinine
    Sodium, pH, microalbuminuria and protein in a urine sample.
    Cistatina C plasmática,

    Bioquímica sérica sistemática con iones

    Gasometría venosa.

    MicroRNAs en suero: microRNA101*, microRNA126* y microRNA127*.

    Concentraciones urinarias de: NGAL*, KIM-1*, NAG*, t-gelsolina*, GM2AP*, y creatinina para homogenización de los valores de los distintos biomarcadores.

    Asimismo se medirá sodio, pH, microalbuminuria y proteínas en una muestra de orina.
    E.5.2.1Timepoint(s) of evaluation of this end point
    48 hours
    48 horas
    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 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) 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 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
    complemento nutricional: sal común (cloruro sódico)
    nutritional supplement: salt (sodium chloride).
    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 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 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 last visit of the last subject
    La última visita del último paciente incluido
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 266
    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
    elderly
    ancianos
    F.4 Planned number of subjects to be included
    F.4.1In the member state266
    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
    Ninguno
    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 Decision2013-08-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-14
    P. End of Trial
    P.End of Trial StatusCompleted
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