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    Summary
    EudraCT Number:2016-002032-33
    Sponsor's Protocol Code Number:NICIR
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-07-15
    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 number2016-002032-33
    A.3Full title of the trial
    Comparative study of the efficacy of oral versus intravenous hydration as a preventive measure of contrast-induced nephropathy (CIN) in patients with renal insufficiency (RI) grade III under study conducting Computed Tomography (CT)
    Estudio comparativo de la eficacia de la hidratación oral versus la intravenosa como medida preventiva de la Nefropatía Inducida por Contraste (NIC) en pacientes con Insuficiencia Renal (IR) grado III sometidos a la realización de estudio de Tomografía Computarizada (TC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to compare the effectiveness of drinking water or receiving endovenous hydration to prevent complications in the kidney in patients with renal insufficiency grade III underwent performing computed tomography (CT)
    Estudio para comparar la eficacia de beber agua o hidratación endovenosa para prevenir complicaciones en el riñón en pacientes con insuficiencia renal de grado III sometidos a la realización de Tomografía Computarizada (TC)
    A.4.1Sponsor's protocol code numberNICIR
    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 SponsorFundacio Privada Clinic per a la Recerca Biomedica
    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 supportFundacio Privada Clinic per a la Recerca Biomedica
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCTU Clinic (Clinical Trials Unit)
    B.5.2Functional name of contact pointDavid García Cinca
    B.5.3 Address:
    B.5.3.1Street AddressC/ Villarroel, 170
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.6E-maildgarcia@clinic.cat
    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 Cloruro de sodio Fresenius 9 mg/ml solución para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi España, S.A.U.
    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
    D.3.2Product code sodium chloride
    D.3.4Pharmaceutical form Solution for infusion in administration system
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSodium Chloride
    D.3.9.1CAS number 7647-14-5
    D.3.9.2Current sponsor codeSODIUM CHLORIDE
    D.3.9.3Other descriptive nameSODIUM CHLORIDE
    D.3.9.4EV Substance CodeSUB12581MIG
    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.IMP: 2
    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 Bicarbonato Sódico 1/6 M Mein solución para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi España, S.A.
    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 bicarbonate
    D.3.2Product code Sodium bicarbonate
    D.3.4Pharmaceutical form Solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsodium bicarbonate
    D.3.9.1CAS number 144-55-8
    D.3.9.2Current sponsor codesodium bicarbonate
    D.3.9.3Other descriptive nameSODIUM BICARBONATE BP
    D.3.9.4EV Substance CodeSUB169196
    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 with renal failure undergoing a computed tomography scan with contrast
    Pacientes con insuficiencia renal sometidos a una tomografía computarizada con contraste
    E.1.1.1Medical condition in easily understood language
    Renal failure grade III
    Insuficiencia renal grado III
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10038435
    E.1.2Term Renal failure
    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
    Check if oral hydration is at least as effective as intravenous hydration in reducing the appearance of contrast-induced nephropathy after performing a computed tomography with intravenous contrast in patients with renal insufficiency grade III.
    Comparar si la hidratación oral es al menos tan efectiva como la hidratación endovenosa en reducir la aparición de nefropatía inducida por contraste tras la realización de una tomografía computarizada con contraste endovenoso en pacientes con insuficiencia renal grado III.
    E.2.2Secondary objectives of the trial
    - Analyze the need for hemodialysis for one month after completion of computed tomography in patients who have undergone oral or intravenous hydration.
    - Analyze the reversibility of the contrast-induced nephropathy 15 days, in patients that have presented at 3 days post computed tomography, in both hydration groups
    - Assess safety in both groups hydration
    - Analizar la necesidad de hemodiálisis durante un mes tras la realización del TC, en pacientes que han seguido hidratación oral o endovenosa.
    - Analizar la reversibilidad de la NIC a los 15 días, en aquellos pacientes que la hayan presentado a los 3 días post TC, en ambos grupos de hidratación
    - Evaluar la seguridad en ambos grupos de hidratación
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a) Patients of both sexes over 18 years
    b) Candidates for a study with computed tomography and intravenous contrast
    c) Pesenten a glomerular filtration rate between 30 and 45 mL / min including both determinations
    d) They have signed the written informed consent after being informed of the objectives and the nature of the case or be unable to have the authorization or agreement of its representative legally designated for inclusion in the clinical trial
    a) Pacientes de ambos sexos mayores de 18 años
    b) Candidatos a la realización de un estudio con tomografía computerizada y contraste endovenoso
    c) Pesenten un filtrado glomerular entre 30 y 45 mL/min incluidas ambas determinaciones
    d) Hayan firmado el consentimiento informado escrito tras ser informados de los objetivos y la naturaleza del mismo o en caso de ser incapaz disponer de la autorización o acuerdo de sus representante legalmente designado de incluirlo en el ensayo clínico
    E.4Principal exclusion criteria
    a) refuse to participate in the study
    b) Pregnancy or lactation
    c) Other risk factors for Contrast Induced Nephropathy:
    - Diabetes mellitus
    - Have an age of 70 years or above
    - Heart failure (defined by a scale New York Heart Association - NYHA 3 or 4)
    - Hypotension (defined as systolic blood pressure <100)
    - Being treated with nephrotoxic medications.
    d) Any disease or a history that, in the investigator's opinion, could confound the results of the study or pose an additional risk to patient treatment.
    a) Que rechacen participar en el estudio
    b) Embarazo o lactancia
    c) Otros factores de riesgo para Nefropatía Inducida por Contraste:
    - presentar diabetes mellitus
    - tener una edad de 70 años o superior
    - presentar insuficiencia cardiaca (definida por una escala New York Heart Association - NYHA 3 o 4)
    - presentar hipotensión (definida por presión arterial sistólica < 100)
    - estar en tratamiento con medicaciones nefrotóxicas.
    d) Cualquier enfermedad o antecedente patológico que, en opinión del investigador, pudieran confundir los resultados del estudio o suponer un riesgo adicional al tratamiento del paciente.
    E.5 End points
    E.5.1Primary end point(s)
    Contrast induced nephropathy defined as a creatinine increase> 0.5 mg / dl comparing the initial blood test to the blood test performed after 48-72 hours to the completion of the computed tomography
    Nefropatía inducida por contraste definida como un aumento de la creatinina >0.5 mg/dl respecto a la analítica inicial a la analítica realizada entre las 48-72 horas posteriores a la realización de la tomografía computerizada.
    E.5.1.1Timepoint(s) of evaluation of this end point
    48-72 hours after the completion of the computed tomography
    48-72 horas posteriores a la tomografía computarizada
    E.5.2Secondary end point(s)
    a) Need for hemodialysis for one month after completion of the computed tomography, among patients who have undergone oral or intravenous hydration.
    b) Reversibility of contrast induced nephropathy 15 days of computed tomography, defined as no increase in creatinine> 0.5 mg / dl compared to the initial analysis performed 15 days after the completion of the analytical computed tomography.
    c) Presence of adverse events, grade 3 adverse events and serious adverse events related to the investigational products during the study follow-up.
    a) Necesidad de hemodiálisis durante un mes tras la realización del TC, entre pacientes que han seguido hidratación oral o endovenosa.
    b) Reversibilidad de la NIC a los 15 días del TC, definida como sin un aumento de la creatinina >0.5 mg/dl respecto a la analítica inicial a la analítica realizada a los 15 días después de la realización del TC.
    c) Presencia de acontecimientos adversos, acontecimientos adversos grado 3 y acontecimientos adversos graves relacionados con los productos en investigación durante el seguimiento del estudio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    15 days
    15 días
    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 No
    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) 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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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
    LVLS
    LVLS
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    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.1.1.1In 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.1.2.1Number of subjects for this age range: 350
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 36
    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 state386
    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 Decision2016-07-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-18
    P. End of Trial
    P.End of Trial StatusOngoing
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