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    Summary
    EudraCT Number:2011-005107-33
    Sponsor's Protocol Code Number:25659
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-03-07
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-005107-33
    A.3Full title of the trial
    dietary nutritional counseling or phosphate binders in the early stages of chronic kidney disease: effects on FGF 23
    counselling dietetico-nutrizionale o chelante del fosforo nelle fasi precoci della malattia renale cronica: effetti su FGF23
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    dietary-nutritional advice or phosphorus-binding drugs in the early stages of chronic kidney disease
    consigli dietetico nutrizionali o farmaci leganti il fosforo nelle fasi iniziali della malattia renale cronica
    A.4.1Sponsor's protocol code number25659
    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 SponsorAZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA
    B.1.3.4CountryItaly
    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 supportprof. Sandro Mazzaferro
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationazienda universitaria policlinico umberto I roma
    B.5.2Functional name of contact pointprof. S.Mazzaferro
    B.5.3 Address:
    B.5.3.1Street Addressvia del policlinico 155
    B.5.3.2Town/ cityroma
    B.5.3.3Post code00161
    B.5.3.4CountryItaly
    B.5.4Telephone number3358417818
    B.5.6E-mailsandro.mazzaferro@uniroma1.it
    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 RENVELA*FL 30CPR RIV 800MG
    D.2.1.1.2Name of the Marketing Authorisation holderGENZYME Srl
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Coated 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 INNSEVELAMER CARBONATE
    D.3.9.1CAS number 845273-93-0
    D.3.9.4EV Substance CodeSUB27758
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number800
    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
    chronic kidney failure
    insufficienza renale cronica
    E.1.1.1Medical condition in easily understood language
    chronic kidney disease
    malattia renale cronica
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10013346
    E.1.2Term Disorders of phosphorus metabolism
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Differences in the variation in circulating levels of FGF-23 (T0-T8) in group A and group B
    Differenze nella variazione dei livelli circolanti di FGF-23 (T8-T0) tra il gruppo A e il gruppo B
    E.2.2Secondary objectives of the trial
    Effects of administration of a chelating phosphorus or counseling on diet and nutritional levels of Vit D, PTH, inflammation, bicarbonatemia, Klotho.Relation between phosphorus content of the diet and levels of FGF-23.
    Effetti della somministrazione di un chelante del fosforo o di un counselling dietetico-nutrizionale sui livelli di Vit D, PTH, infiammazione, bicarbonatemia, Klotho.
    Relazione tra contenuto di fosforo della dieta e livelli di FGF-23.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with CKD stage 2 and 3 with phosphorus> 3.5 mg / dl.
    Pazienti con CKD stadio 2 e 3, con fosforemia &gt; 3.5 mg/dl.
    E.4Principal exclusion criteria
    Age <18 and> 80 years. Therapy with diphosphonates, calcitriol, corticosteroid therapy, nephrotic syndrome, chronic and acute inflammatory diseases. Psychiatric illness. Serum calcium> 10.5 mg / dl
    Pregnancy or breast-feeding.
    Età &lt;18 e &gt;80 anni. Terapia con difosfonati, calcitriolo, terapie con corticosteroidi, sindrome nefrosica, malattie infiammatorie croniche e acute. Malattie psichiatriche. Calcemia &gt;10,5 mg/dl
    Gravidanza o allattamento.
    E.5 End points
    E.5.1Primary end point(s)
    Control Mineral Metabolism in the early stages of chronic renal failure
    controllo del metabolismo minerale nelle fasi precoci dell'insufficienza renale cronica
    E.5.1.1Timepoint(s) of evaluation of this end point
    8 weeks
    8 settimane
    E.5.2Secondary end point(s)
    effects of administration of a chelating phosphorus dietary-nutritional counseling on FGF 23 levels
    effetti della somministrazione di un chelante del fosforo o di un counselling dietetico nutrizionale sui livelli di FGF 23
    E.5.2.1Timepoint(s) of evaluation of this end point
    8 weeks
    8 settimane
    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 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 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
    counselling dietetico-nutrizionale
    diet- nutritional counselling
    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 concerned2
    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 years0
    E.8.9.1In the Member State concerned months6
    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.1.1Number of subjects for this age range: 0
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    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 state34
    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)
    follow-up mineral metabolism
    monitoraggio metabolismo minerale
    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 Decision2012-01-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-12
    P. End of Trial
    P.End of Trial StatusOngoing
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