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    Summary
    EudraCT Number:2019-003101-97
    Sponsor's Protocol Code Number:FJD-NEFROVITD-19-01
    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:2019-12-02
    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 number2019-003101-97
    A.3Full title of the trial
    An unicentric, open, randomized and crossover clinical trial to evaluate vitamin D supplementation effect of colecalciferol versus calcidiol in mineral metabolism in hemodialisis patients.
    Ensayo clínico unicéntrico, abierto, aleatorizado, cruzado, para evaluar el efecto de la administración de colecalciferol versus calcidiol en el metabolismo mineral óseo en pacientes en hemodiálisis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CHolecalciferol vs calcifediol effect on mineral bone metabolism of hemodialysis patients.
    Efecto de la administración de colecalciferol versus calcidiol en el metabolismo mineral óseo en pacientes en hemodiálisis
    A.4.1Sponsor's protocol code numberFJD-NEFROVITD-19-01
    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 SponsorFUNDACION JIMENEZ DIAZ HEALTH RESEARCH INSTITUTE
    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 supportFUNDACION JIMENEZ DIAZ HEALTH RESEARCH INSTITUTE
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFUNDACION JIMENEZ DIAZ HEALTH RESEARCH INSTITUTE
    B.5.2Functional name of contact pointUNIDAD DE INVESTIGACION CLINICA
    B.5.3 Address:
    B.5.3.1Street AddressAVDA REYES CATOLICOS N2
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28040
    B.5.3.4CountrySpain
    B.5.4Telephone number+349155048003214
    B.5.6E-mailmireia.arcas@fjd.es
    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 HIDROFEROL
    D.2.1.1.2Name of the Marketing Authorisation holderFAES FARMA 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.3.4Pharmaceutical form Oral solution
    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 INNCALCIFEDIOL
    D.3.9.1CAS number 19356-17-3
    D.3.9.4EV Substance CodeSUB06045MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.266
    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 DELTIUS
    D.2.1.1.2Name of the Marketing Authorisation holderITALFARMACO, 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.3.4Pharmaceutical form Oral solution
    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 INNCHOLECALCIFEROL
    D.3.9.2Current sponsor code78379
    D.3.9.4EV Substance CodeSUB06045MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    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
    VITAMIN D DEFICIENCY IN HEMODIALISIS PATIENTS
    Déficit de vitamina D en pacientes en Hemodiálisis
    E.1.1.1Medical condition in easily understood language
    Lack of vitamin D in hemodialisis patients
    Déficit de vitamina D en pacientes en Hemodiálisis
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    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 compare the effect of vitamin D suplementation with Cholecalciferol vs calcifediol in plasma levels of calcium, phosphorum and FGF23.
    Comparar el efecto de la suplementación del déficit de vitamina D con Colecalciferol vs calcidiol en los niveles de calcio, fosforo y FGF23.
    E.2.2Secondary objectives of the trial
    To compare the effect of vitamin D suplementation with Cholecalciferol vs calcifediol in plasma levels of PTH and 25-OH-VD.
    Comparar el efecto de la suplementación del déficit de vitamina D con Colecalciferol vs calcidiol en los niveles de PTH y 25-OH-VD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients > 18 years old
    2. Under treatment at Hemodialysis Unit in FJD.
    3. Under treatment with vitamin D suplements
    4. Willing to participate and signing ICF. .
    1. Pacientes mayores de 18 años
    2. Que estén en tratamiento en la Unidad de Hemodiálisis de la FJD.
    3. Que estén en tratamiento con suplementos de vitamina D
    4. Aceptación y firma del consentimiento para el estudio tras haber recibido la información adecuada.
    E.4Principal exclusion criteria
    1. Alergia o hipersensibilidad conocidas a calcidiol, colecalciferol, o a cualquiera de sus componentes
    2. Hipercalcemia.
    3. Insuficiencia Cardíaca severa (clase funcional NYHA IV)
    4. Mujeres potencialmente fértiles que no estén dispuestas a utilizar un método anticonceptivo que se considere efectivo
    5. Embarazo o lactancia
    6. Participantes en otro ensayo clínico con medicamento en los 28 días previos al inicio del reclutamiento.
    7. Negativa a participar
    8. A criterio del investigador, incapacidad del paciente para comprender o cumplir los procedimientos del estudio
    9. Tratamiento actual con fármacos que puedan interferir en los fenómenos de absorción, distribución, metabolismo o excreción de la vitamina D:
    10. Antiepilépticos como Fenitoína, Fenobarbital o Primidona, así como otros inductores enzimáticos
    11. Colestiramina, colestipol u orlistat
    12. Laxantes tipo Parafina (emuliquen®, hodernal®, ordelax®), y aceite mineral (glicerol en solución rectal o supositorios de glicerina): El resto de laxantes sí está permitido (estimulantes tipo Bisacodilo, incrementadores del bolo tipo Plantago Ovata, osmóticos, lactulosa)
    13. Digitálicos
    14. Sales de Magnesio
    15. Verapamilo
    16. Corticosteroides
    17. Patologías que puedan interferir en la farmacocinética o en la farmacodinámicade la vitamina D:
    18. Enfermedad hepática descompensada
    19. Enfermedad Inflamatoria Intestinal
    20. Sarcoidosis, Tuberculosis u otras enfermedades granulomatosas
    21. Calcemia > 10,5 mg/dl, antecedentes de hipercalciuriao litiasis cálcica
    1. Alergia o hipersensibilidad conocidas a calcidiol, colecalciferol, o a cualquiera de sus componentes
    2. Hipercalcemia.
    3. Insuficiencia Cardíaca severa (clase funcional NYHA IV)
    4. Mujeres potencialmente fértiles que no estén dispuestas a utilizar un método anticonceptivo que se considere efectivo
    5. Embarazo o lactancia
    6. Participantes en otro ensayo clínico con medicamento en los 28 días previos al inicio del reclutamiento.
    7. Negativa a participar
    8. A criterio del investigador, incapacidad del paciente para comprender o cumplir los procedimientos del estudio
    9. Tratamiento actual con fármacos que puedan interferir en los fenómenos de absorción, distribución, metabolismo o excreción de la vitamina D:
    10. Antiepilépticos como Fenitoína, Fenobarbital o Primidona, así como otros inductores enzimáticos
    11. Colestiramina, colestipol u orlistat
    12. Laxantes tipo Parafina (emuliquen®, hodernal®, ordelax®), y aceite mineral (glicerol en solución rectal o supositorios de glicerina): El resto de laxantes sí está permitido (estimulantes tipo Bisacodilo, incrementadores del bolo tipo Plantago Ovata, osmóticos, lactulosa)
    13. Digitálicos
    14. Sales de Magnesio
    15. Verapamilo
    16. Corticosteroides
    17. Patologías que puedan interferir en la farmacocinética o en la farmacodinámicade la vitamina D:
    18. Enfermedad hepática descompensada
    19. Enfermedad Inflamatoria Intestinal
    20. Sarcoidosis, Tuberculosis u otras enfermedades granulomatosas
    21. Calcemia > 10,5 mg/dl, antecedentes de hipercalciuriao litiasis cálcica
    E.5 End points
    E.5.1Primary end point(s)
    The primary analysis of the study will be the difference in calcium, phosphorus, 25OH vitamina D, PTH and FGF-23 levels between groups
    El análisis primario del estudio será la diferencia media en los niveles plasmáticos de Calcio, fósforo, 25OH vitamina D, PTH y FGF-23
    E.5.1.1Timepoint(s) of evaluation of this end point
    8 weeks
    8 semanas
    E.5.2Secondary end point(s)
    Not applicable
    No aplicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    NA
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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 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
    Ultima visita ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state20
    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. AFTER THE END OF THE TRIAL, PATIENTS WILL BE MANAGED ACCORDING TO LOCAL STANDARD OF CARE
    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 Decision2020-02-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-07
    P. End of Trial
    P.End of Trial StatusOngoing
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