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    Summary
    EudraCT Number:2020-003011-97
    Sponsor's Protocol Code Number:69HCL20_0071
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-09-23
    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 number2020-003011-97
    A.3Full title of the trial
    Fluconazole as a new therapeutic tool in hypercalciuric patients with increased 1,25(OH)2D levels.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Fluconazole as a new therapeutic tool in hypercalciuric patients with increased 1,25(OH)2D levels
    A.3.2Name or abbreviated title of the trial where available
    The FLUCOLITH study
    A.4.1Sponsor's protocol code number69HCL20_0071
    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 SponsorHospices Civils de Lyon
    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 supportMinistry of Health
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospices Civils de Lyon
    B.5.2Functional name of contact pointRegulatory Project Manager
    B.5.3 Address:
    B.5.3.1Street Address3 quai des Célestins
    B.5.3.2Town/ cityLYON
    B.5.3.3Post code69002
    B.5.3.4CountryFrance
    B.5.4Telephone number+33472406829
    B.5.5Fax number+33472115190
    B.5.6E-maildrci_promo@chu-lyon.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 Fluconazole
    D.2.1.1.2Name of the Marketing Authorisation holderARROW
    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 Capsule
    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 No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hypercalciuria
    E.1.1.1Medical condition in easily understood language
    Hypercalciuria
    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 20.1
    E.1.2Level PT
    E.1.2Classification code 10020590
    E.1.2Term Hypercalciuria
    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
    To demonstrate that fluconazole normalizes or decreases calciuria after 4 months of treatment in patients with hypercalciuria and increased 1,25(OH)2D levels.
    Démontrer que le fluconazole normalise ou diminue la calciurie après 4 mois de traitement chez les patients atteints d'hypercalciurie avec un taux élevé de 1,25(OH)2D.
    E.2.2Secondary objectives of the trial
    1) Effects of fluconazole on the evolution over time of the calcium/phosphate metabolism
    2) Evolution of renal function
    3) Detailed description of the cohort at Baseline and after treatment period
    4) Safety evaluation
    5) Evaluation of the onset of potential mycological resistances
    6) Compliance assessment
    7) Quality of life and treatment satisfaction assessments
    1) Evaluer les effets du fluconazole sur l’évolution dans le temps du métabolisme phospho-calcique
    2) Evaluer l’évolution de la fonction rénale
    3) Description détaillée de la cohorte à la baseline et après la période de traitement
    4) Evaluer la sécurité du fluconazole
    5) Evaluer l’apparition de potentielles résistances fongiques
    6) Etudier l’observance des patients traités
    7) Evaluer la qualité de vie des patients et leur satisfaction du traitement
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients who presented in their medical history nephrolithiasis and/or nephrocalcinosis
    - Patients who had, at least 4 weeks (±2 weeks) before inclusion and at inclusion (V1), a local biological evaluation with:
    - 24-hour urine calcium > 0.1 mmol/kg/day,
    - and 1,25(OH)2D levels ≥ 150 pmol/L,
    - and 25-OH-D levels ≥ 50 nmol/L,
    - and calcemia levels ≤ 2.65 mmol/L.
    - Children from 10 years
    - Adults until 50 years
    - Women using effective methods of contraception during the study period
    - Patients insured or beneficiary of a health insurance plan
    - Evidence of signed and dated informed consent document(s) indicating that the subject and/or his parents/legal guardian has/have been informed of all pertinent aspects of the trial.
    - Patients ayant présenté dans leurs antécédents médicaux une néphrolithiase et/ou une néphrocalcinose
    - Patients ayant eu, au moins 4 semaines (± 2 semaines) avant l'inclusion et lors de l’inclusion (V1), une évaluation biologique avec:
    - une calciurie sur 24 heures > à 0,1 mmol/kg/jour,
    - un taux de 1,25(OH)2D ≥ à 150 pmol/L,
    - un taux de 25-OH-D ≥ à 50 nmol/L,
    - et une calcémie ≤ à 2,65 mmol/L.
    - Enfants entre 10 et 18 ans
    - Adultes entre 18 et 50 ans
    - Femmes utilisant une méthode de contraception efficace pendant la période d'étude
    - Patients assurés ou bénéficiaires d'un régime d'assurance maladie
    - Preuve de document(s) de consentement éclairé signé(s) et daté(s) indiquant que le sujet et/ou ses parents/tuteurs légaux sont/ont été informés de tous les aspects pertinents de l’étude.
    E.4Principal exclusion criteria
    - Patient who already received fluconazole or ketoconazole during the last 6 months before inclusion
    - Patients who cannot stop hydrochlorothiazide or other diuretics during the screening and study period
    - Hypersensibility to fluconazole and/or excipients
    - Patients who need co-administration with other drugs known to prolong the QT interval and metabolized by cytochrome P450 (CYP) 3A4 (pimozide, quinidine and erythromycin)
    - Patients with iatrogenic hypercalciuria (vitamin D intoxication, immobilization)
    - Patients with a corrected QT interval > 450 ms (congenital or inherited Long QT syndrome)
    - Patients who presented heart rhythm disorder
    - Patients with a glomerular filtration rate < 60 mL/min/1.73m²
    - Patients with a liver disease or an abnormality in the initial liver lab test
    - Patients with enuresis
    - Patients with another cause of identified lithiasis
    - Patients suffering from granulomatosis pathology such as sarcoidosis
    - Women who are pregnant or breast feeding, or who have a project of pregnancy
    - Women menopaused
    - Patients with a project of travelling in a sunny area during the study period
    - Immunodeficient patients
    - Patients with other diseases or disorders that could preclude assessment
    - Patient who is participating in another research study that may interfere with the results or conclusions of this study
    - Patients under judicial protection.
    - Patient ayant déjà reçu du fluconazole ou du kétoconazole au cours des 6 mois avant l'inclusion
    - Patients qui ne peuvent pas arrêter l'hydrochlorothiazide ou d'autres diurétiques pendant la période de screening et d'étude
    - Hypersensibilité au fluconazole et/ou aux excipients
    - Patients nécessitant une prise concomittante d'autres médicaments connus pour allonger l'intervalle QT et métabolisés par le cytochrome P450 (CYP) 3A4 (pimozide, quinidine et érythromycine)
    - Patients atteints d'hypercalciurie iatrogène (intoxication à la vitamine D, immobilisation)
    - Patients avec un intervalle QT corrigé > 450 ms (syndrome de QT long congénital ou héréditaire)
    - Patients présentant un trouble du rythme cardiaque
    - Patients avec un débit de filtration glomérulaire < 60 ml/min/1,73m²
    - Patients atteints d'une maladie du foie ou d'une anomalie lors du bilan hépatique initial
    - Patients atteints d'énurésie
    - Patients avec une autre cause de lithiase identifiée
    - Patients ayant une pathologie granulomateuse de type sarcoïdose
    - Femmes enceintes ou allaitantes ou ayant un projet de conception
    - Femmes ménopausées
    - Patients ayant un projet de voyage dans un pays chaud pendant la période de l’étude
    - Patients immunodéprimés
    - Patients avec d’autres pathologies ou troubles pouvant interférer avec les évaluations de l’étude
    - Patients participant à une autre recherche pouvant interférer avec les résultats ou conclusions de cette étude
    - Patients sous protection judiciaire
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients with normalization of 24-hour calciuria (≤ 0.1 mmol/kg/d) between Baseline (V1) and W16 (V8), or with a relative decrease of 30% of 24-hour calciuria between Baseline (V1) and W16 (V8) for patients who still have at W16 a 24-hour calciuria > 0.1mmol/kg/d
    E.5.1.1Timepoint(s) of evaluation of this end point
    16 weeks
    E.5.2Secondary end point(s)
    1) Effects of fluconazole on the evolution over time of the calcium/phosphate metabolism :
    - Serum analysis: calcium, ionized calcium, phosphate, magnesium, PTH, 25-OH-D, 1,25(OH)2D, 24-25(OH)2D, 25-OH-D:24-25(OH)2D ratio, total alkaline phosphatase (V1, V8)
    - 24-hour urine collection: phosphate, calcium, creatinine (V1, V3, V4, V5, V6, V8), TmP/GFR, citrate (V1, V8)
    - OCL test: V2 and V9
    2) Evolution of renal function :
    - Serum creatinine allowing the calculation of eGFR with the FAS formula (V1 and V8)
    - Renal ultrasounds : number and size of lithiasis, nephrocalcinosis (V2, V9)
    3) Detailed description of the cohort at Baseline and after treatment period :
    - Anthropometry (V2, V9)
    - Evaluation of nutritional intakes: calcium, sodium and protein intakes estimated with a dietetic evaluation and completion of 3 questionnaires (V1, V9)
    - Bone evaluation with biomarkers: bone alkaline phosphatases, FGF23, Klotho (V1, V8)
    - Bone evaluation with DXA (V2)
    - Genetic analysis (if not already performed) (V2)
    4) Safety evaluation :
    - Cardiac evaluation: electrocardiogram, corrected QT interval (V1, V9)
    - Monthly blood analyses: Hepatic functions, Complete blood cell counts, Albumin, Serum creatinine, Calcemia, phosphoremia, Lactate deshydrogenase
    5) Evaluation of the onset of potential mycological resistances: Mycological stool sample to evaluate the onset of potential resistance of Candida (V2, V9)
    6) Compliance assessment :
    - Accountability of returned study treatment
    - Information of patients’ diary
    7) Quality of life and treatment satisfaction assessments :
    - Quality of life questionnaires (≥ 18 years, 8-12 years and 13-17 years) reported by patients (V2, V9)
    - Treatment satisfactory questionnaire reported by patients (V9)
    E.5.2.1Timepoint(s) of evaluation of this end point
    W0, W2, W4, W6, W8, W12, W16, W18, W20
    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 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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    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 concerned23
    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 years
    E.8.9.1In the Member State concerned months41
    E.8.9.1In the Member State concerned days15
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 40
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 20
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 20
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    For pediatric patients, subjects will be enrolled in this study only if their parents/legal guardians have signed a written informed consent
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    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 Decision2020-11-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-07-13
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