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    Summary
    EudraCT Number:2019-002795-13
    Sponsor's Protocol Code Number:TACRO-Omics
    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:2020-02-21
    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 number2019-002795-13
    A.3Full title of the trial
    Identification of "omic" biomarkers and their inter and intra-individual variability that allow improvement in the individualization of tacrolimus: uncontrolled clinical trial in pediatric patients with renal transplantation.
    Identificación de biomarcadores ómicos y su variabilidad inter e intraindividual que permitan la mejora en la individualización de tacrolimus: ensayo clínico no controlado en pacientes pediátricos con trasplante renal.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial for the identification of biomarkers based on "omic" techniques (study of large amounts of data), and their inter and intra-individual variability that allow the improvement in the individualization of tacrolimus treatment in pediatric patients with renal transplantation.
    Ensayo clínico para la identificación de biomarcadores basados en técnicas "ómicas" (estudio de grandes cantidades de datos), y su variabilidad inter e intraindividual que permitan la mejora en la individualización del tratamiento con tacrolimus en pacientes pediátricos trasplantados renales.
    A.4.1Sponsor's protocol code numberTACRO-Omics
    A.5.4Other Identifiers
    Name:EUDRA-CT NUMBERNumber:2019-002795-13
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorFundación de Investigación Hospital Universitario 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 supportFundación de Investigación Hospital Universitario La Paz
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación de Investigación Hospital Universitario La Paz
    B.5.2Functional name of contact pointLucía Martínez de Soto
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de la Castellana, 261
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28064
    B.5.3.4CountrySpain
    B.5.4Telephone number0034912071466
    B.5.5Fax number0034912071466
    B.5.6E-maillucia.mdsoto@gmail.com
    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 Tacrolimus STADA
    D.2.1.1.2Name of the Marketing Authorisation holderSTADA
    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 nameTACROLIMUS
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    Oropharyngeal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTACROLIMUS
    D.3.9.1CAS number 104987-11-3
    D.3.9.4EV Substance CodeSUB10797MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1 to 20
    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
    Pediatric patients with renal transplantation (under stable treatment with tacrolimus as immunosuppressant)
    Cohorte de pacientes pediátricos trasplantados renales (con tratamiento estable con tacrolimus como inmunosupresor)
    E.1.1.1Medical condition in easily understood language
    Pediatric patients (less than 17 years old) with renal transplantation (and with a long-term treatment with tacrolimus, with stable doses, which avoids the rejection of the transplanted organ)
    Pacientes pediátricos (menores de 17 años) trasplantados renales (en tratamiento con tacrolimus a dosis estables, que evita el rechazo del órgano trasplantado)
    E.1.1.2Therapeutic area Not possible to specify
    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
    Determination of pharmacogenomic, metabolomic, proteomic and immunological markers that may be associated with intra and interindividual pharmacokinetic variability of tacrolimus in a pediatric population with stable renal transplantation.
    Determinación de marcadores farmacogenómicos, metabolómicos, proteómicos e inmunológicos que se asocien con la variabilidad farmacocinética intra e interindividual de tacrolimus en una población pediátrica con trasplante renal estable.
    E.2.2Secondary objectives of the trial
    1. Study the associations between the different genetic, proteomic, metabolomic and immunological variables.
    2. Study the associations between the AUC and the clinical variables collected prospectively and retrospectively in the study, such as renal function, viral load for CMV, polyomavirus and Epstein Barr virus, previous episodes of graft rejection, and immunological parameters.
    3. Study the associations between the different genetic, proteomic, metabolomic and immunological variables with clinical variables collected prospectively and retrospectively in the study, such as renal function, viral load for CMV, polyomavirus and Epstein Barr virus, previous episodes of graft rejection, and immunological parameters.
    1. Estudiar las asociaciones cruzadas entre las diferentes variables genéticas, proteómicas y metabolómicas e inmunológicas entre sí.
    2. Estudiar las asociaciones entre el AUC y las variables clínicas recogidas prospectivamente y retrospectivamente (según corresponda) en el estudio, tales como función renal, carga viral para CMV, poliomavirus y virus de Epstein Barr, episodios previos de rechazo del injerto, y parámetros inmunológicos.
    3. Estudiar las asociaciones entre las diferentes variables genéticas, proteómicas y metabolómicas e inmunológicas con variables clínicas recogidas prospectivamente y retrospectivamente (según corresponda) en el estudio, tales como función renal, carga viral para CMV, poliomavirus y virus de Epstein Barr, episodios previos de rechazo del injerto, y parámetros inmunológicos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subjects up to 18 years of age, both sexes included.
    - Kidney transplants.
    - Stable treatment with tacrolimus, as primary immunosuppressant, at the time of inclusion in the study. Stable treatment is considered when the variations in the last 3 determinations of tacrolimus levels are less than 30%, being these determinations a minimum of one week appart.
    - Individuals who, previously informed, grant their consent to participate in the study.
    - Sujetos de hasta 18 años de edad, de ambos sexos.
    - Trasplantados renales.
    - Tratamiento estable con tacrolimus, como inmunosupresor primario, en el momento de la inclusión en el estudio. Se considera tratamiento estable cuando las variaciones en las últimas 3 determinaciones de niveles de tacrolimus son menores al 30%, separadas estas determinaciones un mínimo de 1 semana.
    - Individuos que, previamente informados, otorguen su consentimiento para participar en el estudio.
    E.4Principal exclusion criteria
    - Incapacity to understand the instructions or collaborate during the development of the study.
    - Estimated glomerular filtration <30 mL / min / 1.73m2.
    - Graft rejection or dysfunction in the previous 6 months.
    - Incapacidad para entender las instrucciones o colaborar durante el desarrollo del estudio.
    - Filtrado glomerular estimado <30 mL/min/1.73m2.
    - Aparición de un rechazo o disfunción del injerto en los 6 meses previos.
    E.5 End points
    E.5.1Primary end point(s)
    Pharmacokinetic analysis. It will be calculated:
    - AUC through calculation formulas based on abbreviated sampling schemes that have been developed by our group.
    - Calculation of the pharmacokinetic parameters of tacrolimus using Bayesian populations pharmacokinetic methods.

    Pharmacogenetic study: genotypic characterization of the enzymes involved in the concentration of tacrolimus: CYP3A5, CYP3A4, CYP3A7, p-Gp and POR.

    Immunological analysis: measurement by flow cytometry of the expression of the OC40, CD25 and CD40L markers.

    Proteomic analysis: identification and quantification of plasma proteins.

    Metabolomic analysis: identification and quantification of each patient's metabolome.
    Análisis farmacocinético. Se calcularán:
    - AUC mediante fórmulas de cálculo basadas en esquemas de muestreo abreviado que han sido desarrolladas por nuestro grupo.
    - Cálculo de los parámetros farmacocinéticos de tacrolimus mediante métodos farmacocinéticos poblacionales bayesianos.

    Estudio farmacogenético: caracterización genotípica de las enzimas involucradas en la concentración de tacrolimus: CYP3A5, CYP3A4, CYP3A7, p-Gp y POR.

    Análisis inmunológico: medición por citometría de flujo de la expresión de los marcadores OC40, CD25 y CD40L.

    Análisis proteómico: identificación y cuantificación de las proteínas plasmáticas.

    Análisis metabolómico: identificación y cuantificación del metaboloma de cada paciente.
    E.5.1.1Timepoint(s) of evaluation of this end point
    It is estimated that between July 2020 and June 2021 the pharmacogenetic, proteomic, metabolomic and immunological studies will be conducted, as well as the analysis of the results.
    Se estima que entre julio 2020 y junio 2021 se realizarán los estudios farmacogenético, proteómico, metabolómico e inmunológico, así como el análisis de los resultados.
    E.5.2Secondary end point(s)
    • Cross-associations between the different genetic, proteomic, metabolomic and immunological variables with each other.
    • Associations between the AUC and the clinical variables collected prospectively and retrospectively (as appropriate) in the study:
    - Renal function
    - Viral load for CMV, polyomavirus and Epstein Barr virus
    - Previous episodes of graft rejection
    - Immunological parameters.
    • Associations between the different genetic, proteomic, metabolomic and immunological variables with clinical variables collected prospectively and retrospectively (as appropriate) in the study.
    - Renal function
    - Viral load for CMV, polyomavirus and Epstein Barr virus
    - Previous episodes of graft rejection
    - Immunological parameters
    • Asociaciones cruzadas entre las diferentes variables genéticas, proteómicas y metabolómicas e inmunológicas entre sí.
    • Asociaciones entre el AUC y las variables clínicas recogidas prospectivamente y retrospectivamente (según corresponda) en el estudio:
    - Función renal
    - Carga viral para CMV, poliomavirus y virus de Epstein Barr
    - Episodios previos de rechazo del injerto
    - Parámetros inmunológicos.
    • Asociaciones entre las diferentes variables genéticas, proteómicas y metabolómicas e inmunológicas con variables clínicas recogidas prospectivamente y retrospectivamente (según corresponda) en el estudio.
    - Función renal
    - Carga viral para CMV, poliomavirus y virus de Epstein Barr
    - Episodios previos de rechazo del injerto
    - Parámetros inmunológicos
    E.5.2.1Timepoint(s) of evaluation of this end point
    It is estimated that between July 2020 and June 2021 the pharmacogenetic, proteomic, metabolomic and immunological studies will be conducted, as well as the analysis of the results.
    Se estima que entre julio 2020 y junio 2021 se realizarán los estudios farmacogenético, proteómico, metabolómico e inmunológico, así como el análisis de los resultados.
    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 No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Metabolomic, proteomic, immunological parameters.
    Metabolómica, proteómica, parámetros inmunológicos.
    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 No
    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 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 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 concerned6
    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 trial will end after the analysis of the data obtained. It will last two years from the begining of recruitment of patients until the publication of the study results.
    El estudio finalizará tras el análisis de los datos obtenidos. Tendrá una duración de dos años desde el inicio del reclutamiento hasta la publicación de los resultados del estudio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 180
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 90
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 90
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 state180
    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)
    The treatment after the subject ends the participation in the trial will be the same as before the trial, and will be based on the decision of their usual nephrologist.
    El tratamiento del sujeto tras su participación en el estudio será el mismo que antes de éste, y será indicado según la decisión de su nefrólogo habitual.
    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 Decision2020-04-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-21
    P. End of Trial
    P.End of Trial StatusOngoing
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