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    Summary
    EudraCT Number:2017-002096-26
    Sponsor's Protocol Code Number:MV-3-2017
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-06-22
    Trial results View 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 ConcernedDenmark - DHMA
    A.2EudraCT number2017-002096-26
    A.3Full title of the trial
    Investigate the differences between treating Chronic Kidney Disease - Mineral and Bone Disorder with an iron-containing phosphate binder or a calcium-containing phosphate binder in dialysis patients.
    Monitorering af forskelle ved behandling af Chronic Kidney Disease - Mineral and Bone Disorder med en jernholdig fosfatbinder sammenlignet med en calciumholdig fosfatbinder ved dialysepatienter.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigate the differences between treating Chronic Kidney Disease - Mineral and Bone Disorder with an iron-containing phosphate binder or a calcium-containing phosphate binder in patients with Kidney Disease treated with dialysis .
    Monitorering af forskelle ved behandling af Chronic Kidney Disease - Mineral and Bone Disorder med en jernholdig fosfatbinder sammenlignet med en calciumholdig fosfatbinder ved patienter med kronisk nyresygdom behandlet med dialyse.
    A.3.2Name or abbreviated title of the trial where available
    MAVA
    MAVA
    A.4.1Sponsor's protocol code numberMV-3-2017
    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 SponsorUniversitetsklinik for Nyresygdomme og Blodtryksforhøjelse, Regionshospitalet Holstebro; Hospitalsenheden Vest
    B.1.3.4CountryDenmark
    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 supportUniversitetsklinik for Nyresygdomme og Blodtryksforhøjelse, Regionshospitalet Holstebro; Hospitalsenheden Vest
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitetsklinik for Nyresygdomme og Blodtryksforhøjelse, Regionshospitalet Holstebro; Hospitalsenheden Vest
    B.5.2Functional name of contact pointMarie Houmaa Vrist
    B.5.3 Address:
    B.5.3.1Street AddressLægårdvej 12
    B.5.3.2Town/ cityHolstebro
    B.5.3.3Post code7500
    B.5.3.4CountryDenmark
    B.5.4Telephone number004578436585
    B.5.6E-mailmarvri@rm.dk
    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 Velphoro
    D.2.1.1.2Name of the Marketing Authorisation holderVifor France SA
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameVelphoro
    D.3.4Pharmaceutical form Chewable 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 INNVelphoro
    D.3.9.1CAS number 12134-57-5
    D.3.9.3Other descriptive nameSUCROFERRIC OXYHYDROXIDE
    D.3.9.4EV Substance CodeSUB168208
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 No
    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 nameSodium Fluoride F 18/ 18F-NaF
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN18F-NaF
    D.3.9.1CAS number 8061-51-6
    D.3.9.3Other descriptive nameSODIUM FLUORIDE (18F)
    D.3.9.4EV Substance CodeSUB124979
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 Yes
    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
    Chronic Kidney Disease - Mineral and Bone Disorder (CKD-MBD), especially bone metabolism and blood vessel calcification
    Chronic Kidney Disease - Mineral and Bone Disorder (CKD-MBD) med særligt fokus på knoglemetabolismen og åreforkalkning
    E.1.1.1Medical condition in easily understood language
    Examination of the disturbances of bone metabolism and increased risk of atherosclerosis in renal disease patients.
    Undersøgelse af de forstyrrelser i knoglemetabolismen og øget risiko for åreforkalkning der ses hos nyresyge patienter
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10064848
    E.1.2Term Chronic kidney disease
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10027425
    E.1.2Term Metabolic bone disorders
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10078095
    E.1.2Term Chronic kidney disease-mineral and bone disorder
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10012347
    E.1.2Term Dependence on renal dialysis
    E.1.2System Organ Class 100000004869
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate whether treatment with an iron- or calcium-containing phosphate binder can affect differently the results from 18F-NaF PET/CT, bALP, osteocalcin, FGF23 og OPG/RANKL ratio. Differences in the stiffness of blood vessel assessed with applanation tonometry. Finally, we investigate changes in calcium score (TBR) and iron status
    Undersøge om behandling med en jern- eller calciumholdig fosfatbinder kan påvirke resultaterne fra 18F-NaF PET/CT, bALP, osteocalcin, FGF23 og OPG/RANKL ratio forskelligt. Måle forskelle i karstivhed ved behandlingerne vurderet med applannationstonometri. Desuden vurderes forskelle i kalkscore (TBR) og jernstatus.
    E.2.2Secondary objectives of the trial
    "not applicable"
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    35-65 years old hemodialysis patients
    35-65 årige hæmodialysepatienter
    E.4Principal exclusion criteria
    Inability to give informed consent, pregnancy, lactation, not radically treated cancer, alcohol abuse or drug abuse. Within three months: fractures, AMI, TCI, kidney transplant or parathyroidectomy.
    graviditet eller amning
    manglende evne til at afgive informeret samtykke
    ikke radikalt behandlet cancersygdom
    alkoholmisbrug
    stofmisbrug
    allergi for Unikalk eller Velphoro
    indenfor tre måneder: nyretransplantation, parathyroidektomim, knoglebrud, AMI eller TCI
    E.5 End points
    E.5.1Primary end point(s)
    SUVmax og Ki
    SUVmax og Ki
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the trail, when all subjects have completed and the blood samples and PET/CT- scans are analyzed
    I slutningen af forsøget, når alle forsøgspersoner er afsluttet og blodprøver og PET/CT - skanningerne er analyseret.
    E.5.2Secondary end point(s)
    Biomarkers: bALP, FGF23, osteocalcin and OPG/sRANKL ratio
    PET/CT: SUVmean, SUVpeak, SUVA50%, K1, K2, K3, K4 and calcium score (TBR).
    Iron parameters: p-iron, ferritin, transferrin.
    Applanation tonometry: Heart Rate Variability (HRV), aPWV og AIx/central blood pressure (PVA)
    Biomarkører: bALP, FGF23, osteeocalcin, OPG/sRANKL ratio
    PET/CT: SUVmean, SUVpeak, SUVA50%, K1, K2, K3, K4 og kalkscore (TBR)
    Jernstatus: p-jern, ferritin, transferrin.
    Applanationstonometri: Heart Rate Variability (HRV), aPWV og AIx/centralt BT (PVA)

    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of the trail, when all subjects have completed and the blood samples and PET/CT- scans are analyzed
    I slutningen af forsøget, når alle forsøgspersoner er afsluttet og blodprøver og PET/CT - skanningerne er analyseret.
    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) 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    kosttilskud, Unikalk
    dietary supplements, Unikalk
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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.1.1.2Preterm 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: 35
    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 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 state35
    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
    ingen
    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 Decision2017-07-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-24
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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