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    Summary
    EudraCT Number:2016-002913-23
    Sponsor's Protocol Code Number:VITARENAL
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-08-29
    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 number2016-002913-23
    A.3Full title of the trial
    Phase II clinical trial to evaluate the effect of 25 OH vitamin D on renal progression in patients with Chronic Kidney Disease stage 3 and 25OH vitamin D deficiency
    Ensayo clínico fase II para evaluar el efecto de la 25 OH vitamina D sobre la progresión renal en paciente con Enfermedad Renal Crónica estadio 3 y déficit de 25OH vitamina D
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to evaluate the effect of vitamin D on renal progression in patients with Chronic Kidney Disease and vitamin D deficiency
    Ensayo clínico para evaluar el efecto de la vitamina D en la progresión renal de pacientes con Enfermedad Renal Crónica y déficit de vitamina D
    A.3.2Name or abbreviated title of the trial where available
    VITARENAL
    VITARENAL
    A.4.1Sponsor's protocol code numberVITARENAL
    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 SponsorFundación Hospital Alcorcón
    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 supportItalfármaco
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportCarlos III Health Insitute (National Health System)
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSpanich Clinical Research Network
    B.5.2Functional name of contact pointMarta del Álamo
    B.5.3 Address:
    B.5.3.1Street AddressCarretera de Colmenar Km9.100
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28034
    B.5.3.4CountrySpain
    B.5.4Telephone number+34913368825
    B.5.5Fax number+34913368825
    B.5.6E-mailmartadelalamo.hrc@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 DELTIUS 25000
    D.2.1.1.2Name of the Marketing Authorisation holderITALFARMACO SpA
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.2Product code A11CC05
    D.3.4Pharmaceutical form Oral solution in single-dose container
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 Yes
    D.3.11.13.1Other medicinal product typeVitamin D3
    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
    Chronic Kidney Disease in patients with D vitamin deficit
    Enfermerdad Renal Crónica en pacientes con déficit de vitamina D
    E.1.1.1Medical condition in easily understood language
    Chronic Kidney Disease in patients with D vitamin deficit
    Enfermerdad Renal Crónica en pacientes con déficit de vitamina D
    E.1.1.2Therapeutic area Body processes [G] - Physiological processes [G07]
    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
    Compare the progression of CKD defined as the number of patients increasing by 50 % the baseline serum creatinine value or reach CKD stage 5 , dialysis or transplantation , or death between the group receiving 25 OH vitamin D and the group without active treatment
    Comparar la progresión de ERC definida como número de paciente que incrementan en 50 % la cifra de creatinina sérica inicial o alcanzan enfermedad renal crónica estadio 5, diálisis o trasplante, o muerte entre el grupo que recibe 25 OH vitamina D y el grupo sin tratamiento activo
    E.2.2Secondary objectives of the trial
    - Compare proteinuria decrease between groups
    - To evaluate and compare the safety and tolerance to treatment with 25 OH vitamin D
    - Compare cardiovascular morbidity and mortality (death from CV causes , MI, hospitalization for heart failure , coronary angiography and / or coronary revascularization , stroke, and amputation and / or revascularization of lower limbs ) between groups
    - Compare the time of diagnosis of secondary hyperparathyroidism (PTH KDOQI > 250 pg / mL ) between groups
    - Comparar la reducción de proteinuria entre los grupos
    - Evaluar y comparar la seguridad y tolerancia al tratamiento con 25 OH vitamina D entre los grupos
    - Comparar la Morbi-mortalidad cardiovascular (muerte de causa CV, IAM, hospitalización por IC, coronariografía y/o revascularización coronaria, ACVA, amputación y/o revascularización de MMII) entre los grupos
    - Comparar el tiempo del diagnóstico de hiperparatirodismo secundario (PTH KDOQI > 250 pg/mL) entre los grupos
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age 18-80 years
    • Stage 3 Kidney Disease ( CKD EPI eGFR 60-30 ml / min / 1.73m2 )
    • 25 OH vitamin D levels < 15 ng / Ml
    • microalbuminuria / creatinine ratio > 30 mg / g confirmed in first morning urine
    • Edad 18-80 años
    • Enfermedad renal estadio 3 (eFG CKD EPI 60-30 ml/min/1.73m2)
    • Niveles 25 OH vitamina D < 15 ng/Ml
    • Cociente Microalbuminuria /creatinina > 30 mg/g confirmado en primera micción de la mañana
    E.4Principal exclusion criteria
    • Bone fracture in the last three months
    • Previous condition of intestinal malabsorption or chronic diarrhea.
    • Treatment with phenobarbital, phenytoin , rifampin , sucralfate , digoxin , steroids or other medication may affect the metabolism of vitamin D
    • Previous liver failure
    • Primary hyperparathyroidism
    • calcimimetic treatment in the last 6 months
    • active granulomatous disease
    • Current treatment with some form of vitamin D
    • Pregnancy- lactation
    • Background of calcium nephrolithiasis well documented origin
    • serum phosphate > 5.5 mg / dL in any determination in the last 3 months
    • Serum calcium > 10.0 mg / dL in any determination in the last 3 months
    • Fractura ósea en los tres últimos meses
    • Historia de malabsorción intestinal o diarrea crónica.
    • Tratamiento con fenobarbital, fenitoína, rifampicina, sucralfato, digoxina, esteroides u otra medicación de pueda afectar el metabolismo de la vitamina D
    • Antecedentes de fallo hepático
    • Hiperparatiroidismo primario
    • Tratamiento calcimiméticos en los últimos 6 meses
    • Enfermedad granulomatosa activa
    • Tratamiento actual con alguna forma de vitamina D
    • Embarazo- lactancia
    • Antecedentes de litiasis renal de origen cálcico bien documentada
    • Fosfato sérico >5.5 mg/dL en alguna determinación en los últimos 3 meses
    • Calcio sérico >10.0 mg/dL en alguna determinación en los últimos 3 meses
    E.5 End points
    E.5.1Primary end point(s)
    - Number of patients with increased serum creatinine value of at least 50% compared to baseline , reach stage 5 CKD ( CKD-EPI eGFR < 15 ml / min / 1.73m2 ) , dialysis , renal transplant or death
    - Number of patients with albumin-corrected hypercalcemia > 11 mg/dl
    - Proporción de pacientes que tienen aumento de la cifras de creatinina serica al menos del 50% respecto a la cifra basal, alcanzan ERC estadio 5 (eFG CKD-EPI < 15 ml/min/1.73m2), diálisis, trasplante renal o muerte
    - Número de pacientes con hipercalcemia corregida por albúmina > 11 mg/dl
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every study visit (10 visits every 2-4 months)
    En cada visita (total 10 visitas realizadas entre 2 y 4 meses)
    E.5.2Secondary end point(s)
    - Proportion of patients with proteinuria reduction > 50% from baseline
    - Proportion of patients achieving KDOQI PTH > 250 pg / mL )
    - Average time that patients reach KDOQI PTH > 250 pg / mL )
    - Number and severity of any Adverse Reaction
    - Withdrawals due to D3 vitamin secondary effects or D3 vitamin intolerance
    - Number of patients with hyperphosphoremia > 5.5 mg/dl
    - Proporción de pacientes con reducción de proteinuria > 50% respecto a situación basal
    - Proporción de pacientes que alcanzan PTH KDOQI > 250 pg/mL)
    - Tiempo medio en que los pacientes alcanzan PTH KDOQI > 250 pg/mL)
    - Proporción y severidad de los efectos adversos asociados a la vitamina D3 durante el estudio (reacciones adversas)
    - Número de pacientes que abandonan el estudio por efectos secundarios o intolerancia a la vitamina D·
    - Número de pacientes con hiperfosforemia > 5.5 mg/dl
    E.5.2.1Timepoint(s) of evaluation of this end point
    Every study visit (10 visits every 2-4 months)
    En cada visita (total 10 visitas realizadas entre 2 y 4 meses)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 Yes
    E.8.2.3.1Comparator description
    No tratamiento
    Non treatment
    E.8.2.4Number of treatment arms in the trial2
    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 concerned5
    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
    El estudio finalizará cuando el último paciente realice la última visita
    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 months51
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 state170
    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
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Spanish Clinical Trial Network (SCReN)
    G.4.3.4Network Country Spain
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-10-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-01-18
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