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    Summary
    EudraCT Number:2014-001296-32
    Sponsor's Protocol Code Number:FC/HULP-2014_01
    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:2014-05-22
    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 number2014-001296-32
    A.3Full title of the trial
    Pharmacokinetic and pharmacodynamic optimization of amikacin treatment in patients with terminal renal failure under conventional hemodialysis: randomized clinical trial of two model of administration
    OPTIMIZACIÓN CINÉTICA-DINÁMICA DE LA DOSIFICACIÓN DE AMIKACINA EN PACIENTES EN HEMODIÁLISIS CONVENCIONAL: ENSAYO CLÍNICO ALEATORIZADO DE DOS PAUTAS DE ADMINISTRACIÓN
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Optimization of treatment regimen of amikacin in patients with terminal renal failure in hemodialysis
    Optimización de la pauta de tratamiento de Amikacina en pacientes con Insuficiencia Renal Cronica terminal en hemodialisis
    A.4.1Sponsor's protocol code numberFC/HULP-2014_01
    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 de La Paz
    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 supportINSTITUTO DE SALUD CARLOS III
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitario La Paz
    B.5.2Functional name of contact pointUCICEC
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de la Castellana, 261.
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28046
    B.5.3.4CountrySpain
    B.5.4Telephone number+34912071876
    B.5.5Fax number+34912071876
    B.5.6E-mailucicec@idipaz.es
    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 AMIKACINA NORMON
    D.2.1.1.2Name of the Marketing Authorisation holderNORMON
    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 nameAMIKACINA
    D.3.4Pharmaceutical form Solution for injection/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 INNAMIKACIN
    D.3.9.1CAS number 37517-28-5
    D.3.9.4EV Substance CodeSUB05431MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    Terminal renal failure under hemodialysis
    Insuficiencia renal crónica en hemodiálisis
    E.1.1.1Medical condition in easily understood language
    Terminal renal failure under hemodialysis
    Insuficiencia renal crónica en hemodiálisis
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10038444
    E.1.2Term Renal failure chronic
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10014647
    E.1.2Term End stage 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
    To determine whether administration of amikacin pre-hemodialysis compared with the standard regimen (post-hemodialysis) is able to obtain a pharmacokinetic profile that ensures greater bactericidal activity preventing the emergence of resistance while reducing the risk of drug toxicity.
    Determinar si la administración de amikacina pre-hemodiálisis comparada con la pauta estándar (post-hemodiálisis) es capaz de obtener un perfil farmacocinético que asegure una mayor actividad bactericida evitando la aparición de resistencias y a la vez reducir el riesgo de toxicidad del fármaco.
    E.2.2Secondary objectives of the trial
    1. Compared serum trough and peak amikacin administered before hemodialysis vs trough and peak serum levels of amikacin administered after hemodialysis.
    2. To evaluate the therapeutic efficacy between the administration of amikacin before hemodialysis vs after hemodialysis.
    3. Assessing the safety profiles between the administration of amikacin before hemodialysis vs after hemodialysis.
    4. Pharmacoeconomic assessment of costs arising from hospitalization.
    1. Comparar los niveles séricos valle y pico de amikacina administrada antes de la sesión de hemodiálisis vs niveles séricos valle y pico de amikacina administrada después de la hemodiálisis.
    2. Evaluar la eficacia terapéutica entre la administración de la amikacina antes de la hemodiálisis vs después de la hemodiálisis.
    3. Evaluar los perfiles de seguridad entre la administración de la amikacina antes de la hemodiálisis vs después de la hemodiálisis.
    4. Estudio farmacoeconómico de gastos derivados del ingreso hospitalario.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? Subjects men and women diagnosed with chronic renal failure in Hemodialysis, regardless of time of evolution who will initiate treatment with intravenous amikacin.
    ? Age over 18 years.
    ? Subjects that after receiving information about the design, project purposes and the potential risks that he may arise, allow written consent to participate in the study.
    ?Sujetos varones y mujeres con diagnóstico de insuficiencia renal crónica terminal en HD, independientemente del tiempo de evolución, que inicie tratamiento con amikacina intravenosa.
    ?Edad superior a 18 años.
    ?Sujetos que tras haber recibido información sobre el diseño, los fines del proyecto, los posibles riesgos de que él puedan derivarse y de que en cualquier momento pueden denegar su colaboración, otorguen por escrito su consentimiento de participar en el estudio.
    E.4Principal exclusion criteria
    ? Pregnant women or lactating
    ? Patients with liver disease
    ? Inability to understand instructions or assist in the development of the study and/or absence of signed consent.
    ?Mujeres embarazas o en periodo de lactancia
    ?Pacientes con enfermedad hepática
    ?Incapacidad para entender las instrucciones o colaborar durante el desarrollo del estudio y/o ausencia de consentimiento firmado.
    E.5 End points
    E.5.1Primary end point(s)
    ? Antibacterial activity "in vitro" reproducing different serum levels of amikacin in the Pharmacokinetics-Pharmacodynamics simulator.
    ?Actividad antibacteriana ?in vitro? reproduciendo los diferentes niveles séricos de amikacina en el simulador PK-PD.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Not applicable
    No aplicable
    E.5.2Secondary end point(s)
    ?MIC of microorganisms isolated from patients of the unit of interest (Hemodialysis, Nephrology).
    ? Decrease in bacterial load and concentration at different times post-dose.
    ? Bactericidal speed during the dosing interval.
    ? Time for bacterial regrowth.
    ? Determination of the PK/PD values ??necessary to prevent the emergence of resistant subpopulations.
    ? Determination of population resistance profile relative to the MIC.
    ? Percentage of patients who present peak levels of amikacin in steady state within the therapeutic range recommended for hemodialysis patients.
    ? Percentage of time that the peak level remains within recommended therapeutic ranges throughout the treatment cycle.
    ?CMI de los micro-organismos aislados en los pacientes y en la unidad de interés (Hemodiálisis, Servicio de Nefrología).
    ?Descenso de la carga bacteriana a diferentes tiempos y concentración post-dosis.
    ?Velocidad bactericida durante el intervalo de administración.
    ?Tiempo para el recrecimiento bacteriano.
    ?Determinación de los valores PK/PD necesarios para prevenir la aparición de subpoblaciones resistentes.
    ?Determinación del perfil poblacional de resistencia en relación con la CMI.
    ?Porcentaje de pacientes que presente niveles pico de amikacina en equilibrio estacionario dentro del rango terapéutico recomendado para pacientes en hemodiálisis.
    ?Porcentaje de tiempo que permanece el nivel pico dentro de rangos terapéuticos recomendados durante todo el ciclo de tratamiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    No aplicable
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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 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
    Administración de amikacina post hemodiálisis
    Administration of amikacin after hemodialysis
    E.8.2.4Number of treatment arms in the trial2
    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 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
    End of treatment with amikacin for any reason (death, improvement or change of antibiotic) provided the last patient recruited (experimental arm: 12 patients and clinical practice arm: 12 patients).
    La finalización del tratamiento por cualquiera de las causas (muerte, mejoría o cambio de antibiótico) del último paciente previsto reclutar (12 pacientes rama experimental y 12 pacientes rama de práctica clínica habitual).
    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) Yes
    F.1.2.1Number of subjects for this age range: 24
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    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 state24
    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 Decision2014-07-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-05
    P. End of Trial
    P.End of Trial StatusOngoing
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