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    Summary
    EudraCT Number:2017-004450-41
    Sponsor's Protocol Code Number:TXRENAL-17
    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:2018-01-30
    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 number2017-004450-41
    A.3Full title of the trial
    PHASE IV, OPEN, UNICENTRIC AND PILOT CLINICAL TRIAL TO EVALUATE THE INFLUENCE ON THE BIODISPONIBILITY AND PHARMACOKINETIC CHARACTERISTICS OF ENVARSUS® COMPARED WITH ADVAGRAF® OF FAST OR INGESTION
    IN STABLE PATIENTS WITH RENAL TRANSPLANTATION
    ENSAYO CLÍNICO DE FASE IV, ABIERTO, UNICÉNTRICO Y PILOTO PARA EVALUAR LA INFLUENCIA SOBRE LA BIODISPONIBILIDAD Y CARACTERÍSTICAS FARMACOCINÉTICAS DE ENVARSUS® COMPARADO CON ADVAGRAF® DEL AYUNO O LA INGESTA EN PACIENTES ESTABLES CON TRASPLANTE RENAL
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PHASE IV, OPEN, UNICENTRIC AND PILOT CLINICAL TRIAL TO EVALUATE THE INFLUENCE ON THE BIODISPONIBILITY AND PHARMACOKINETIC CHARACTERISTICS OF ENVARSUS® COMPARED WITH ADVAGRAF® OF FAST OR INGESTION
    IN STABLE PATIENTS WITH RENAL TRANSPLANTATION
    ENSAYO CLÍNICO DE FASE IV, ABIERTO, UNICÉNTRICO Y PILOTO PARA EVALUAR LA INFLUENCIA SOBRE LA BIODISPONIBILIDAD Y CARACTERÍSTICAS FARMACOCINÉTICAS DE ENVARSUS® COMPARADO CON ADVAGRAF® DEL AYUNO O LA INGESTA EN PACIENTES ESTABLES CON TRASPLANTE RENAL
    A.4.1Sponsor's protocol code numberTXRENAL-17
    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 SponsorConsorci Mar Parc de Salut
    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 supportConsorci Mar Parc de Salut
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationConsorci Mar Parc de Salut
    B.5.2Functional name of contact pointHospital del Mar
    B.5.3 Address:
    B.5.3.1Street AddressPasseig Marítim 25-29
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08003
    B.5.3.4CountrySpain
    B.5.4Telephone number34932483689
    B.5.6E-mailafaura@parcdesalutmar.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.3.4Pharmaceutical 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 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/kg milligram(s)/kilogram
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number0.1
    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 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 Advagraf
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma Europe B.V.
    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.3.4Pharmaceutical form Capsule
    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 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/kg milligram(s)/kilogram
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number0.1
    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
    Trasplante renal y inmunosupresión
    Kidney transplant and immunosuppression
    E.1.1.1Medical condition in easily understood language
    Trasplante renal y inmunosupresión
    Kidney transplant and immunosuppression
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    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
    To assess the influence of fasting or food intake on the bioavailability and pharmacokinetic characteristics of tacrolimus in the preparation Envarsus® compared to Advagraf® in stable patients with kidney transplantation.
    Evaluar la influencia del ayuno o la ingesta de comida sobre la biodisponibilidad y características farmacocinéticas del tacrólimus en el preparado Envarsus® comparado con Advagraf® en pacientes estables con trasplante renal.
    E.2.2Secondary objectives of the trial
    To compare tolerability (when we refer to the amount and severity of adverse effects) between Envarsus® and Advagraf®
    Comparar la tolerabilidad (cuando nos referimos a la cantidad y severidad de los efectos adversos) entre Envarsus® y Advagraf®
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with a stable kidney transplant after the first year of the transplant, with low immunological risk.
    2. At least during the last 3 months before entering the trial, both the 8 patients treated with Advagraf® and the 8 patients treated with Envarsus® should not have presented relevant changes in the dose (consider relevant changes> 1 mg in dose) and blood levels should be between 4 and 10 ng / ml.
    3. Patients treated with Myfortic® that have not presented relevant changes in the dose, during the last 3 months before entering the study.
    4. Patients treated with a dose of Prednisone of 5 mg / day at least during the 3 months before entering the study.
    5. Patients ≥18 years.
    6. Caucasian patients.
    7. BMI between 18.5-29.9 Kg / m2.
    8. Patient who have given their written consent to participate in the trial.
    1. Pacientes con un trasplante renal estable después del primer año del trasplante, con bajo riesgo inmunológico.
    2. Cómo mínimo durante los 3 últimos meses antes de entrar en el ensayo, tanto los 8 pacientes tratados con Advagraf® como los 8 pacientes tratados con Envarsus®, no deben haber presentado cambios relevantes en la dosis (considérese relevantes cambios > 1 mg en dosis) y los niveles en sangre deben de estar entre 4 y 10 ng/ml.
    3. Pacientes tratados con Myfortic® que no hayan presentado cambios relevantes en la dosis, durante los últimos 3 meses antes de entrar en el estudio.
    4. Pacientes tratados con una dosis de Prednisona de 5mg/día cómo mínimo durante los 3 meses antes de entrar en el estudio.
    5. Pacientes ≥ 18 años.
    6. Pacientes caucásicos.
    7. IMC entre 18.5-29.9 Kg/m2.
    8. Paciente que hayan dado su consentimiento por escrito a participar en el ensayo.
    E.4Principal exclusion criteria
    1. Drug interaction that may interfere with the bioavailability of tacrolimus (Annex 1).
    2. Patients with a history of neoplasic gastrointestinal disease (gastrointestinal disease or gastrointestinal surgery)
    3. Changes in intestinal transit (diarrhea or constipation), or any significant increase in bowel movements per day during the last week of inclusion in the trial.
    1. Interacción de entre medicamentos que pueda interferir con la biodisponibilidad del tacrólimus (anexo 1).
    2. Pacientes con antecedentes de enfermedad gastrointestinal maligna (enfermedad gastrointestinal o alguna cirugía gastrointestinal)
    3. Alteraciones del tránsito intestinal (diarrea o estreñimiento), o cualquier aumento significante de las deposiciones al día durante la última semana a la inclusión al ensayo.
    E.5 End points
    E.5.1Primary end point(s)
    Not applicable
    No aplica
    E.5.1.1Timepoint(s) of evaluation of this end point
    Not applicable
    No aplica
    E.5.2Secondary end point(s)
    Not applicable
    No aplica
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    No aplica
    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 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 No
    E.8.1.6Cross over Yes
    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 Yes
    E.8.2.3.1Comparator description
    Advagraf
    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
    Adverse event (s) that require the interruption of study medication
    Abnormal value (s) of laboratory
    Abnormal result (s) of test procedures
    Documented chronic rejection
    Unacceptable toxicity
    Criterion of the doctor in charge of treatment
    Protocol violation
    Withdrawal of consent by the patient
    Appearance of concomitant pathology that limits the continuation of the trial
    Loss of tracking
    Death.
    Pregnancy
    Acontecimiento(s) adverso(s) que requieran la interrupción de la medicación del estudio
    Valor(es) anormal(es) de laboratorio.
    Valores anormales en las pruevas
    Rechazo crónico documentado
    Toxicidad inaceptable.
    Criterio del facultativo encargado del tratamiento
    Violación de protocolo
    Retirada del consentimiento por parte del paciente
    Aparición de patología concomitante que limite continuar en el ensayo
    Pérdida de seguimiento.
    Problemas administrativos.
    Muerte.
    Embarazo
    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 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: 6
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 No
    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 state16
    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)
    standard care
    práctica clínica
    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 Decision2018-05-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-28
    P. End of Trial
    P.End of Trial StatusOngoing
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