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    Summary
    EudraCT Number:2010-024023-25
    Sponsor's Protocol Code Number:Nefrovid2010
    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:2011-07-08
    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 number2010-024023-25
    A.3Full title of the trial
    An open label, parallel groups, phase III, clinical trial to assess the antiproteinuric effects of the vitamin D derivates in patients with chronic kidney disease and vitamin D insufficiency.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ENSAYO CLÍNICO, ABIERTO, DE GRUPOS PARALELOS, FASE III, PARA VALORAR EL EFECTO ANTIPROTEINÚRICO DE LOS DERIVADOS DE LA VITAMINA D EN PACIENTES CON ENFERMEDAD RENAL CRÓNICA E INSUFICIENCIA DE VITAMINA D.
    A.3.2Name or abbreviated title of the trial where available
    Nefrovid2010
    A.4.1Sponsor's protocol code numberNefrovid2010
    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 SponsorLorenzo Victor, PhD
    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 supportMinisterio de Sanidad y Política Social (national health system)
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitario de Canarias
    B.5.2Functional name of contact pointClinical Trial Unit
    B.5.3 Address:
    B.5.3.1Street AddressOfra s/n. La Cuesta
    B.5.3.2Town/ cityLa Laguna
    B.5.3.3Post code38320
    B.5.3.4CountrySpain
    B.5.4Telephone number+34922678115
    B.5.5Fax number+34922647112
    B.5.6E-maila.aldea@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 Zemplar
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Laboratories 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.3.1Product namezemplar
    D.3.2Product code 68022
    D.3.4Pharmaceutical form Capsule, soft
    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 INND00930
    D.3.9.1CAS number 131918-61-1
    D.3.9.3Other descriptive namePARICALCITOL
    D.3.9.4EV Substance CodeSUB09627MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 Hidroferol
    D.2.1.1.2Name of the Marketing Authorisation holderFaes Farma SA
    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 nameHidroferol
    D.3.2Product code 53683
    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 µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number266
    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
    Enfermedad renal crónica estadio II a IV más proteinuria residual >0,5 gr/día (en dos o más ocasiones consecutivas) más tratamiento con bloqueantes del SRAA durante al menos 3 meses. Niveles séricos de calcifediol en rango de insuficiencia (15-30 ng/ml).
    E.1.1.1Medical condition in easily understood language
    Enfermedad renal crónica con proteninuria >0,5 g/día con tratamiento con bloqueantes del Sistema Renina angiotensina Aldosterona durante al mneos 3 meses e insuficiencia de vitamina D.
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level SOC
    E.1.2Classification code 10038359
    E.1.2Term Renal and urinary disorders
    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
    Valorar el efecto antiproteinúrico adicional del tratamiento con derivados de la Vitamina D, en pacientes con Enfermedad Renal Crónica (ERC) estadio II a IV, con insuficiencia de vitamina D, y proteinuria residual mayor a 0,5 gramos/día.
    E.2.2Secondary objectives of the trial
    Evaluar otros potenciales efectos beneficiosos ?pleiotrópicos- descritos en los derivados de la Vitamina D:
    1. Efectos sobre la rigidez arterial y las calcificaciones vasculares.
    2. Efectos sobre las alteraciones del metabolismo mineral (niveles de Calcio, fósforo, Calcitriol, hormona paratiroidea y fosfatoninas (FGF23).
    3. Efectos sobre el metabolismo de la glucosa (secreción de primera fase de insulina, insulinoresistencia)
    4. Efectos sobre los marcadores de inflamación (proteína C reactiva; adiponectina)
    5. Progresión de la enfermedad renal: Pendiente en el tiempo del GFR estimado y tiempo de Supervivencia libre de diálisis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Pacientes de ambos sexos mayores de 18 años
    2. Paciente que haya otorgado su consentimiento informado por escrito
    3. Enfermedad renal crónica estadio II a IV más proteinuria residual >0,5 gr/día (en dos o más ocasiones consecutivas) más tratamiento con bloqueantes del SRAA durante al menos 3 meses.
    4. Niveles séricos de calcifediol en rango de insuficiencia (15-30 ng/ml).
    E.4Principal exclusion criteria
    1. Mal control de la hipertensión arterial (mayor o igual 180 mmHg/110),
    2. Diabetes mal controlada (HbA1c mayor de 9,5 en el último trimestre),
    3. Hipercalcemia (<10,2 mg/dL) o hiperfosfatemia (>5,5 mg/dL), CaxPO4>50, hipercalciuria (cociente Ca/Cr urinario > 0,15)
    4. Tratamiento con vitamina D o cualquiera de sus análogos
    5. Insuficiencia hepática ( AST o ALT > 3 veces superior al límite normal)
    6. Historia de malabsorción intestinal o diarrea crónica
    7. Nefrolitiasis activa.
    8. Tratamiento con medicación que pueda alterar el metabolismo de vitamina D (fenobarbital, fenitoína, rifampicina)
    9. Participación en otro ensayo clínico en los 3 últimos meses.
    10. Alcoholismo activo
    11. Antecedentes de neoplasias excepto las cutáneas no melanoma.
    12. Mujeres embarazadas o en período de lactancia.
    13. Hipersensibilidad a vitamina D o a alguno de sus excipientes.
    14. Cualquier otra condición que a criterio del investigador prohíba su participación en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    ? Cociente proteina/creatinina y albúmina/creatinina en muestra matinal de orina: basal y trimestral a partir de un mes de iniciado el protocolo terapéutico.
    ? Función renal determinada por estimación del filtrado mediante la fórmula MDRD, e inversa de la creatinina serica (1/Creatinina) basal y trimestral durante el seguimiento. Se utilizará la pendiente en el tiempo de ambas variables.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Basal y a los 3 meses de iniciado el tratamiento.
    E.5.2Secondary end point(s)
    Variables de respuesta del metabolismo mineral:
    ? Calcemia, fosforemia, fosfatasa alcalina total, PTH: Trimestral o según necesidad clínica.
    ? Niveles de Calcitriol basal y final.
    ? Niveles de FGF23 basal y final
    ? Niveles de 25OHD3 trimestralmente
    ? Calciuria, fosfaturia y creatinina en orina de 24 hs y en muestra aislada matinal, trimestralmente.

    Otras variables de respuesta:
    ? T.A. sistólica y diastólica. Necesidades de hipotensores (incluyendo diuréticos).
    ? Perfil lipídico (col-t, HDL-c, LDL-c, Trigliceridos), Uricemia, Nitrogeno urinario, bicarbonatemia, Hemoglobina/EPO, albumina serica (se determinarán siguiendo la práctica clínica habitual, al menos semestralmente)
    ? Marcadores de Inflamación: Proteina C reactiva ultrasensible (trimestralmente); Adiponectina (Basal y final).
    ? Metabolismo de la Glucosa:
    o En no diabéticos: HbA1c; Sobrecarga oral de Glucosa; Indices de Resistencia a la Insulina; Indice de secreción de insulina (primera fase). Basal y final.
    o En Diabéticos: necesidades de Insulina y HbA1c.
    ? Evolución de las Calcificaciones Vasculares: Rx de lateral de abdomen, Rx AP de pelvis. Semicuantificación por el método de Kaupila y de Adragao. Basal y final
    ? Evolución de la Rigidez vascular: Presión del pulso y Velocidad de la onda de pulso (VOP; Complior®) basal y final.
    ? Ecocardiografía: Indice de masa ventricular izquierda, y parámetros de disfunción diastólica. Basal y final.

    Otras variables a controlar:
    ? Duración de la ERC
    ? Etiología de la ERC
    ? Antecedentes de eventos cardiovasculares
    ? Eventos cardiovasculares durante el estudio
    ? Eventos infecciosos durante el estudio: Urinarios, respiratorios, y otros.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Está establecido en el apartado anterior para cada una de las variables.
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 Yes
    E.8.1.7.1Other trial design description
    Llevará el tratamiento indicado por su médico en la práctica clínica habitual.
    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
    sólo el tratamiento standard
    E.8.2.4Number of treatment arms in the trial3
    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.8.4.1Number of sites anticipated in Member State concerned1
    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
    El fin del ensayo se corresponderá con la última visita de seguimiento realizada al último paciente reclutado.Si el ensayo finaliza prematuramente o se suspende, el promotor debe informar rápidamente al investigador y a las autoridades reguladoras de la finalización o suspensión y de la razón para ello. El promotor o investigador debe informar rápidamente al CEIC y facilitarle la razón de la finalización o suspensión, tal y como especifiquen los requisitos reguladores pertinentes.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 174
    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 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 state174
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 174
    F.4.2.2In the whole clinical trial 174
    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)
    - Medical history
    - Physical examination with anthropometric measurements
    - Vital signs: blood pressure, heart rate, temperature and respiratory rate.
    - Biochemistry
    - Detection and evaluation of adverse events, if applicable.
    - Collect and delivery of the patient´s CRF.
    Después de la última visita, se realizará una visita adicional llamada Visita fin del estudio en la que se evaluará lo siguiente:

    - Historia clínica
    - Exploración física junto a las medidas antropométricas
    - Constantes vitales: tensión arterial, frecuencia cardiaca, temperatura y frecuencia respiratoria.
    - Bioquímica
    - Detección y evaluación de Acontecimientos adversos, si procede.
    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 Decision2011-09-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-12-23
    P. End of Trial
    P.End of Trial StatusOngoing
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