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    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).

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    Summary
    EudraCT Number:2015-005275-24
    Sponsor's Protocol Code Number:TACPKPD
    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:2016-02-17
    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 number2015-005275-24
    A.3Full title of the trial
    Conversion pharmacodynamic study in stable renal transplant patients receiving tacrolimus two times a day to a new formulation of tacrolimus - LCP Tacro - 1 time a day.
    Estudio Farmacodinámico de conversión en pacientes trasplantados renales establesque reciben tacrolimus 2 veces al día a una nueva formulación de tacrolimus - LCP Tacro - 1 vez al día.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Conversion study in renal transplant patients receiving tacrolimus two times a day to a new formulation of tacrolimus - LCP Tacro - 1 time a day.
    Estudio de conversión en pacientes trasplantados renales estables que reciben tacrolimus 2 veces al día a una nueva formulación de tacrolimus - LCP Tacro - 1 vez al día.
    A.3.2Name or abbreviated title of the trial where available
    TACPKPD
    TACPKPD
    A.4.1Sponsor's protocol code numberTACPKPD
    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 SponsorHOSPITAL UNIVERSITARI DE BELLVITGE
    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 supportINSTITUT D'INVESTIGACIÓ BIOMÈDICA DE BELLVITGE
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationINSTITUT D'INVESTIGACIÓ BIOMÈDICA DE BELLVITGE
    B.5.2Functional name of contact pointCAROLINA POLO
    B.5.3 Address:
    B.5.3.1Street AddressFEIXA LLARGA S/N
    B.5.3.2Town/ cityL'HOSPITALET DE LLOBREGAT
    B.5.3.3Post code08907
    B.5.3.4CountrySpain
    B.5.4Telephone number+34932607385
    B.5.5Fax number+34932607607
    B.5.6E-mailcpolo@idibell.cat
    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 Envarsus
    D.2.1.1.2Name of the Marketing Authorisation holderChiesi Farmaceutici S.p.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 nameEnvarsus
    D.3.2Product code LCP-TACRO
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLCP-TACRO
    D.3.9.3Other descriptive nameTACROLIMUS MONOHYDRATE
    D.3.9.4EV Substance CodeSUB23141
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.75 to 4
    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
    REJECTION PROPHYLAXIS IN RENAL TRANSPLANT PATIENTS
    PROFILAXIS DE RECHAZO EN PACIENTES TRASPLANTADOS RENALES
    E.1.1.1Medical condition in easily understood language
    REJECTION PROPHYLAXIS IN RENAL TRANSPLANT PATIENTS
    PROFILAXIS DE RECHAZO EN PACIENTES TRASPLANTADOS RENALES
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10050436
    E.1.2Term Prophylaxis against renal transplant rejection
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10038533
    E.1.2Term Renal transplant
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of this study is to compare the area under the curve (AUC) of CN activity after administration of a sustained release formulation (LCP- Tacro, Envarsus®) compared to an immediate release formulation (Prograf®) of TAC in renal transplant patients.
    El objetivo principal de este estudio es comparar el área bajo la curva (AUC) de la actividad CN tras la administración de una formulación de liberación sostenida (LCP- Tacro, Envarsus®) en comparación a una formulación de liberación inmediata (Prograf®) de TAC en pacientes trasplantados renales.
    E.2.2Secondary objectives of the trial
    1. pharmacokinetic study AUC 0-24 h of each TAC formulation 12h (Prograf®) and the new formulation of TAC every 24h (LCP- Tacro, Envarsus®).
    2. Study PK / PD: To establish the relationship PK TAC (drug exposure) and PD (activity CN) of both formulations. Set TAC trough concentrations for optimal inhibition of CN.
    3. Analysis of drug exposure according to CYP3A (CYP3A4 and CYP3A5 * 22 * 3) and ABCB1 (C3435T) polymorphism.
    4. Security Settings (pharmacovigilance).
    5. Development of PPK by bayesiona prediction model based on the results obtained from the study.
    1. Estudio farmacocinético de AUC 0-24h de la formulación de TAC cada 12h (Prograf®) y de la nueva formulación de TAC cada 24h (LCP- Tacro, Envarsus®).
    2. Estudio PK/PD: Para establecer la relación PK de TAC (exposición al fármaco) y PD (actividad CN) de ambas formulaciones. Establecer las concentraciones mínimas de TAC para obtener la inhibición de CN óptima.
    3. Análisis de la exposición al fármaco según los polimorfismos CYP3A (CYP3A4*22 y CYP3A5*3) y ABCB1 (C3435T).
    4. Parámetros de seguridad (farmacovigilancia).
    5. Desarrollo del modelo PPK por predicción bayesiona a partir de los resultados del obtenidos del estudio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adult patients (? 18 years).
    ? Receivers cadaveric renal graft or living donor with more than 6 months post-transplant evolution.
    ? Patients receiving Prograf stable and stable TAC trough concentrations between 5-10ng / ml non-interrupted oral dose for at least 10 days (steady state conditions).
    ? receiving concomitant immunosuppressive medication allowed: sodium or mycophenolate mofetil and corticosteroids.
    ? Subjects must be willing to give their written informed consent to testing and be able to do consent. If a subject can not give written informed consent independently, you can do your legal representative instead.
    ? Women of childbearing age must undergo a pregnancy test at the time of inclusion and accept the use of a medically acceptable method of contraception during the selection and receive medication as specified in the protocol.
    ? Pacientes adultos (? 18 años).
    ? Receptores de injerto renal de donante cadáver o donante vivo con más de 6 meses de evolución post-trasplante.
    ? Pacientes que recibieron una dosis oral no-interrumpida estable de Prograf® y con concentraciones mínimas estables de TAC entre 5-10ng/ml, durante al menos 10 días (condiciones de estado estacionario).
    ? Que estén recibiendo medicación inmunosupresora concomitante permitida: mofetil micofenolato o micofenolato sódico y corticosteroides.
    ? Los sujetos deberán estar dispuestos a otorgar su consentimiento informado por escrito para el ensayo y ser capaces de hacerlo. Si un sujeto no puede otorgar su consentimiento informado por escrito de forma independiente, podrá hacerlo su representante legal en su lugar.
    ? Las mujeres en edad fértil deberán realizar un test de embarazo en el momento de la inclusión y aceptar el uso de un método anticonceptivo médicamente aceptable durante el periodo de selección y mientras reciban la medicación especificada en el protocolo.
    E.4Principal exclusion criteria
    ? Patients on dialysis or treatment of rejection after transplantation.
    ? Patients treated with substances with potential interaction with TAC, particularly potent inhibitors of CYP3A4 (such as telaprevir, boceprevir, ritonavir, ketoconazole, voriconazole, itraconazole, telithromycin or clarithromycin) or inducers of CYP3A4 (such as rifampin or rifabutin).
    ? Patients participating in another clinical trial or treated with any investigational drug within 30 days prior to inclusion.
    ? Patients with liver disease.
    ? The patient or donor with the current diagnosis or history of malignancy within the past 5 years except carcinoma nonmetastatic basal or squamous cell skin treated successfully.
    ? pregnant or breast-feeding women and all women of childbearing age unless they use reliable contraception. A pregnancy test will be performed at screening and at the end of the study.
    ? Receiver of any other organ transplanted kidney.
    ? The recipients of bone marrow or stem cell transplant.
    ? Recipients of a kidney from a donor ABO incompatible.
    ? Patients with donor specific anti-HLA antibodies.
    ? Recipients of a kidney with anticipated cold ischemia time of ? 24 hours.
    ? Patients with concomitant uncontrolled infection, systemic infection in treatment, or any other unstable medical condition that could interfere with the study objectives.
    ? Patients with severe diarrhea, vomiting, active peptic ulcer or gastrointestinal disorder that can affect the absorption of TAC.
    ? Patients with white blood cell count ? 2.8 x 109 / L unless the absolute neutrophil count (ANC) is ? 1.0 x 109 / L
    ? Patients with platelet count ? 50 x 109 / L
    ? Patients with levels of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) exceeding> 3 times the upper limit of normal during the 30 days prior to the transplant procedure.
    ? Patients with known hypersensitivity to TAC or any of the excipients in the formulation Envarsus®.
    ? unable to swallow study medication patients.
    ? Patients with any form of current substance abuse, psychiatric disorder or a condition that, in the investigator's opinion, may invalidate the communication with the investigator.
    ? Patients who require a high intake of potassium or potassium-sparing diuretics.
    ? Patients treated with substances with known nephrotoxic or neurotoxic effects.
    ? positive for hepatitis C virus (HCV-RNA positive) and / or hepatitis B virus (HBV DNA or HBsAg positive) receivers.
    ? positive for human immunodeficiency virus (HIV-Ab positive) receivers.
    ? unable to understand the effects and risks of the study, who can not give informed consent in writing or unwilling to comply with the study protocol patients
    ? Pacientes en diálisis o tratamiento del rechazo desde el trasplante.
    ? Pacientes tratados con sustancias con potencial interacción con TAC, particularmente inhibidores potentes de CYP3A4 (tales como telaprevir, boceprevir, ritonavir, ketoconazol, voriconazol, itraconazol, telitromicina o claritromicina) o inductores de CYP3A4 (tales como rifampicina o rifabutina).
    ? Pacientes que participaran en otro ensayo clínico o que fueron tratados con cualquier otro fármaco de investigación en los 30 días anteriores a la inclusión.
    ? Pacientes con enfermedad hepática.
    ? El paciente o el donante con el diagnóstico actual o antecedentes de neoplasia maligna en los últimos 5 años, excepto el carcinoma de células basales o escamosas no metastásico de la piel tratada con éxito.
    ? Mujeres embarazadas o en periodo de lactancia y todas las mujeres en edad fértil a menos que usen métodos anticonceptivos fiables. Una prueba de embarazo se realizará en la selección y al final del estudio.
    ? Receptor de cualquier órgano trasplantado aparte del riñón.
    ? Los beneficiarios de trasplante de médula ósea o trasplante de células madre.
    ? Los receptores de un riñón de un donante incompatible ABO.
    ? Pacientes con anticuerpos anti-HLA específicos del donante.
    ? Los receptores de un riñón con un tiempo de isquemia fría anticipado ? 24 horas.
    ? Pacientes con una infección no controlada concomitante, infección sistémica en tratamiento, o cualquier otra condición médica inestable que podría interferir con los objetivos del estudio.
    ? Pacientes con diarrea severa, vómitos, úlcera péptica activa o un trastorno gastrointestinal que pueden afectar la absorción de TAC.
    ? Pacientes con un recuento de glóbulos blancos ? 2,8 x 109 / L a menos que el recuento absoluto de neutrófilos (RAN) sea ? 1,0 x 109 / L.
    ? Pacientes con un recuento de plaquetas ? 50 x 109 / L.
    ? Pacientes con niveles de aspartato aminotransferasa (AST) o de alanina aminotransferasa (ALT) que superen > 3 veces el límite superior de lo normal durante los 30 días anteriores al procedimiento de trasplante.
    ? Pacientes con hipersensibilidad conocida a TAC o a cualquiera de los excipientes presentes en la formulación Envarsus®.
    ? Pacientes incapaces de tragar la medicación del estudio.
    ? Pacientes con cualquier forma de abuso de sustancias actual, trastorno psiquiátrico o una condición que, en opinión del investigador, puede invalidar la comunicación con el investigador.
    ? Pacientes que requieren de una ingesta elevada de potasio o diuréticos ahorradores de potasio.
    ? Pacientes tratados con sustancias con reconocidos efectos nefrotóxicos o neurotóxicos.
    ? Receptores positivos para el virus de la hepatitis C (VHC-ARN positivo) y / o hepatitis B virus (ADN-VHB o HBsAg positivo).
    ? Receptores positivos para virus de inmunodeficiencia humana (VIH-Ab positivo).
    ? Pacientes incapaces de comprender los efectos y riesgos del estudio, que no pueden dar su consentimiento informado por escrito, o que no están dispuestos a cumplir con el protocolo de estudio.
    E.5 End points
    E.5.1Primary end point(s)
    CALCINEURIN ACTIVITY (AREA UNDER THE CURVE)
    ACTIVIDAD DE LA CALCINEURINA (AREA BAJO LA CURVA)
    E.5.1.1Timepoint(s) of evaluation of this end point
    BASELINE AND 35 DAYS POST CONVERSION
    EN EL PUNTO BASAL Y A LOS 35 DÍAS DE LA CONVERSIÓN
    E.5.2Secondary end point(s)
    PHARMACOKINETICS OF ENVARSUS COMPARED TO PROGRAF
    FARMACOCINÉTICA DE ENVARSUS COMPARADA CON PROGRAF
    E.5.2.1Timepoint(s) of evaluation of this end point
    BASELINE AND 35 DAYS POST CONVERSION
    EN EL PUNTO BASAL Y A LOS 35 DÍAS DE LA CONVERSIÓN
    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 No
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 years
    E.8.9.1In the Member State concerned months15
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months15
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state25
    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 Decision2016-03-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-03
    P. End of Trial
    P.End of Trial StatusOngoing
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