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    Summary
    EudraCT Number:2014-003496-29
    Sponsor's Protocol Code Number:I13034
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-01-08
    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 ConcernedFrance - ANSM
    A.2EudraCT number2014-003496-29
    A.3Full title of the trial
    Designing a Bayesian model of the plasma clearance of Calcium edetate de sodium, with a limited sampling strategy for the calculation of Glomerular Filtration Rate (GFR) and validity assessment compared to the renal clearance of Inulin.
    Conception d’un modèle bayésien de la clairance plasmatique du Calcium édétate de sodium, avec une stratégie de prélèvements limités, pour le calcul du Débit de Filtration Glomérulaire et évaluation de la validité par rapport à la clairance rénale à l’équilibre de l’Inuline.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Designing a Bayesian model of the plasma clearance of Calcium edetate de sodium, with a limited sampling strategy for the calculation of Glomerular Filtration Rate (GFR) and validity assessment compared to the renal clearance of Inulin.
    A.3.2Name or abbreviated title of the trial where available
    DFGBay
    A.4.1Sponsor's protocol code numberI13034
    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 SponsorUniversity Hospital, Limoges
    B.1.3.4CountryFrance
    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 supportUniversity Hospital, Limoges
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationuniversity Hospital, Limoges
    B.5.2Functional name of contact pointprincipal investigator
    B.5.3 Address:
    B.5.3.1Street Address02 avenue Martin Luther King
    B.5.3.2Town/ cityLimoges
    B.5.3.3Post code87 042
    B.5.3.4CountryFrance
    B.5.4Telephone number+33555058012
    B.5.5Fax number+33555056422
    B.5.6E-mailjulien.allard@chu-limoges.fr
    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 CALCIUM EDETATE DE SODIUM SERB 50 mg/ml, solution injectable I.V.
    D.2.1.1.2Name of the Marketing Authorisation holderSERB
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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 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 Inutest 25% ampoules
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi Austria GmbH
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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 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
    Maladie chronique des reins
    E.1.1.1Medical condition in easily understood language
    Chronic Kidney Disease
    Maladie chronique des reins
    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 17.1
    E.1.2Level LLT
    E.1.2Classification code 10064848
    E.1.2Term Chronic kidney disease
    E.1.2System Organ Class 100000004857
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective is to develop a Bayesian model of the plasma clearance of Calcium édétate de sodium (DFGBay) in a population of patients who need an accurate measurement of GFR.
    L’objectif principal est de concevoir un modèle bayésien de la clairance plasmatique du Calcium édétate de sodium (DFGBay) utilisant une stratégie de prélèvements limités pour le calcul du DFG et d’évaluer sa validité par rapport à la clairance rénale à l’équilibre de l’Inuline (gold standard) dans une population de patients devant bénéficier d’une mesure exacte du DFG.
    E.2.2Secondary objectives of the trial
    Estimate, by the realization of the second calculation of the GFRBay, the reliability of this technique.
    Evaluer, par la réalisation d’un deuxième calcul du DFGBay, la fiabilité de cette technique (reproductibilité).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A- Inclusion criteria for V1:
    - For transplanted patients : patients from 18 to 80 years, after estimation of their renal function by MDRDs formulas, regardless their nephropathy, regardless the age of the transplantation, with a normal state body hydratation, with a social insurance and who have given their prior consent.
    - For other patients : patients from 18 to 80 years, after estimation of their renal function by MDRDs formulas, who need a reliable assess of their renal function, with a normal state body hydratation, with a social insurance and who have given their prior consent.

    B- Inclusion criteria for V2:
    - Transplanted patients who have participed to V1, with stable clinical conditions, with a stable GFR (less than 30% variation of creatinine clearance by MDRDs formulas) and who have given their prior consent.
    A- POUR V1 :
    PATIENTS TRANSPLANTES RENAUX
    • Patients âgés de 18 à 80 ans inclus
    • Après estimation de leur fonction rénale par la formule du MDRDs
    • Quelle que soit la néphropathie de base
    • Quel que soit l’âge de la greffe
    • En état d’euvolémie
    • Affiliés à un régime de sécurité sociale
    • Ayant donné leur consentement éclairé

    PATIENTS NON TRANSPLANTES RENAUX
    • Patients âgés de 18 à 80 ans inclus
    • Après estimation de leur fonction rénale par la formule du MDRDs
    • Nécessitant une mesure exacte du DFG, par exemple (non exhaustif) :
    o Sujets sains dans une démarche de don de rein vivant
    o Sujets devant bénéficier d’une néphrectomie
    o Patients chez qui l’évaluation de la fonction rénale est nécessaire mais insuffisante car imprécise par les formules courantes d’évaluation du DFG.
    •En état d’euvolémie
    • Affiliés à un régime de sécurité sociale
    • Ayant donné leur consentement éclairé

    B- POUR V2 :
    • Patients transplantés rénaux ayant participé à V1
    • Avec un état clinique stable
    • Avec une fonction rénale stable définie par une variation de la clairance de la créatinine calculée par MDRDs inférieure à 30% par rapport à V1
    • Ayant donné leur consentement éclairé.
    E.4Principal exclusion criteria
    - Hypersensitivity to Calcium edetate de sodium, Inulin or excipients,
    - lead or other heavy metal intoxication,
    - volume expansion or dehydratation,
    - acute renal disease,
    - bladder voiding affections,
    - coagulation disorders,
    - poor venous capital,
    - people in guardianship,
    - patients already involved in an other research,
    - women in child bearing age without any method of contraception,
    - pregnant or lactating women.
    • Hypersensibilité connue au Calcium Edétate de sodium et à l’Inuline
    • Traitement en cours par Digitaliques
    • Intoxication en cours au plomb ou à tout autre métal lourd
    • Variation aiguë de la volémie documentée dans les 8 jours précédents i.e : perte ou prise de poids supérieure à 2kg
    • Pathologie rénale aiguë : rejet aigu, pyélonéphrite aiguë…
    • Trouble de la vidange vésicale i.e : résidu post-mictionnel > 100mL, incontinence urinaire
    • Trouble de la coagulation connu ou documenté (selon les antécédents)
    • Capital veineux ne permettant pas la pose de 2 voies périphériques de bon calibre
    • Sujets sous tutelle, curatelle ou en incapacité de donner leur consentement éclairé
    • Sujet déjà inclus dans un autre protocole de recherche interventionnel ou en période d’exclusion.
    • Femme en âge de procréer sans contraception efficace
    • Femme enceinte ou allaitante
    E.5 End points
    E.5.1Primary end point(s)
    Primary end point is the DFGBay: the DFG assessed by the Bayesian model of the plasma clearance of Calcium edetate de sodium.the DFG assessed by the Bayesian model of the plasma clearance of Calcium edetate de sodium.
    Il s’agit de la valeur du DFGBay c'est-à-dire le DFG calculé par le modèle bayésien de la clairance plasmatique du Calcium édétate de sodium.
    E.5.1.1Timepoint(s) of evaluation of this end point
    90, 120, 180 240, 270, 380, 440 and 500 minutes after T0.
    90, 120, 180 240, 270, 380, 440 et 500 minutes après T0.
    E.5.2Secondary end point(s)
    Secondary outcomes are Concordance of GFRBay measured during V1 and during V2 to determine the reliability of the method.
    Concordance du DFGBay de la 1ère visite et celui de la 2ème visite (pour déterminer la fiabilité de la mesure DFGBay)
    E.5.2.1Timepoint(s) of evaluation of this end point
    V1 and V2
    V1 et V2
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    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 No
    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 trial1
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days9
    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) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state50
    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
    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 Decision2014-10-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-24
    P. End of Trial
    P.End of Trial StatusOngoing
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