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    Summary
    EudraCT Number:2019-002570-31
    Sponsor's Protocol Code Number:APHP180560
    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:2020-11-27
    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 number2019-002570-31
    A.3Full title of the trial
    Randomized multicenter double-blind controlled trial comparing anakinra to prednisone for gout flare in patients with chronic kidney disease stage 4-5 or kidney transplantation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized double-blind controlled trial comparing anakinra to prednisone for gout flare in patients with chronic kidney disease or kidney transplantation
    A.3.2Name or abbreviated title of the trial where available
    ANA4CKD
    A.4.1Sponsor's protocol code numberAPHP180560
    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 SponsorAssitance Publique - Hôpitaux de Paris
    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 supportFrench Ministery of Health
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAssistance Publique - Hôpitaux de Paris
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street Address1 avenue Claude Vellefaux
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number33144 84 17 44
    B.5.5Fax number33144 84 17 01
    B.5.6E-maildidier.bouton@aphp.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 Kineret
    D.2.1.1.2Name of the Marketing Authorisation holderSwedish Orphan Biovitrum AB
    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.3.1Product namekineret
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNANAKINRA
    D.3.9.1CAS number 143090-92-0
    D.3.9.4EV Substance CodeSUB05500MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.2.1.1.1Trade name Cortancyl
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI-AVENTIS FRANCE
    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 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 INNprednisone
    D.3.9.3Other descriptive namePREDNISONE
    D.3.9.4EV Substance CodeSUB10020MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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
    Men and women of more than 18 years old with a stage 4 or 5 kidney insufficiency or or a kidney insufficiency and an untreated gout attack
    Hommes et femmes de plus de 18 ans ayant une insuffisance rénale stades 4/5 ou une transplantation rénale et une crise de goutte non traitée
    E.1.1.1Medical condition in easily understood language
    Men and women of more than 18 years old with a stage 4 or 5 kidney insufficiency or or a kidney insufficiency and an untreated gout attack
    Hommes et femmes de plus de 18 ans ayant une insuffisance rénale stades 4/5 ou une transplantation rénale et une crise de goutte non traitée
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    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
    To demonstrate superiority of anakinra over prednisone in the trreatment of gout attack in patient suffering from stage 4 or 5 chronic kidney disease and kideny transplantation
    Démontrer la supériorité de l’anakinra, l’agoniste recombinant de l’antagoniste de l’interleukine 1, par rapport à la prednisone dans le traitement des crises de goutte chez les patients ayant une maladie rénale chronique stades 4 ou 5 ou une transplantation rénale
    E.2.2Secondary objectives of the trial
    1. Anakinra efficacy
    • To compare pain variation from inclusion to d5
    • To compare speed of attack resolution (improvment of more than 80% or pain below 20mm)
    • To compare time to response to treatment (improvement of more than 50%)
    • To compare treatment duration
    • To compare number of responding patients (improvement at d3)
    • To compare number of relapse during the month of participation
    • To compare healthcare consumption during the mont of study participation: hospitalisatioon duration, antalgic consumption, sick leave duration,
    • To compare quality of life and handicap
    2. Anakinra tolerance
    • To compare reaction at the injection site
    • To compare severe infections
    • To compare decrease of Neutrophile or platelets
    • To compare comorbidity decompensation : AHT, diabetis, dilipidemia, Chronic kideny disease
    • To compare cardiovascular events: myocard infarction, arythma, cardiac insuficiency burst, brain stroke
    •Comparer les variations de la douleur de l’inclusion à J5
    •Comparer la vitesse de résolution des crises (amélioration de plus de 80% ou douleur inférieure à 20 mm)
    •Comparer le temps de réponse au traitement (amélioration de plus de 50%)
    •Comparer la durée de traitement
    •Comparer le nombre de patients répondeurs (amélioration à J3)
    •Comparer le nombre de rechute durant le mois de l’étude
    •Comparer la consommation de soins durant le mois de l’étude: durée d’hospitalisation, consommation des antalgiques, durée d’arrêt de travail
    •Comparer la qualité de vie et le handicap
    2.Tolérance de l’anakinra
    •Comparer les réactions au point d’injection
    •Comparer les infections sévères
    •Comparer les baisses des neutrophiles ou des plaquettes
    •Comparer la décompensation des comorbidités : HTA, diabète, dyslipidémie, obésité, MRC
    •Comparer les événements cardiovasculaires : infarctus du myocarde, trouble du rythme, poussée d’insuffisance cardiaque, accident vasculaire cérébraux
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - adult of more than 18 years old
    - Gout attack confirmed by evidence urat cristal in joint liquid analysis or of the tophus or ultrasound examination of the joint or
    - Gout attack according to NIjmegen citeria (score > 8/13) for the following items :
    • Maen (2 pts)
    • Previous attack (2 pts)
    • Fisrt ray of metatarsophangeal (2.5 pts)
    • Attack maximum in less than 24 hours (0.5pt)
    • Redness (1 pt)
    • AHT or cardiovascular disease (1.5 pts)
    • URICEMIA > 360 µmol/l during crisis (3.5 pts)
    - Crisis ≤ 5 jours
    - VEA ≥ 50/100
    - Chronic Kidney disease stage 4 or 5 or kidney transplanted patient
    - Adulte de plus de 18 ans
    - Crise de goutte confirmée par mise en évidence des cristaux d’urate par analyse du liquide articulaire ou du tophus ou par échographie de l’articulation atteinte ou
    - Crise de goutte selon critères de Nijmegen (présence d’un score > 8/13) selon les items suivants :
    • Homme (2 pts)
    • Crise antérieure (2 pts)
    • Atteinte de la métatarsophalangienne du premier rayon (MTP1) (2.5 pts)
    • Installation maximale en moins de 24h (0.5pt)
    • Rougeur (1 pt)
    • HTA ou maladies cardiovasculaire (1.5 pts)
    • Uricémie > 360 µmol/l pendant la crise (3.5 pts)
    - Crise ≤ 5 jours
    - EVA ≥ 50/100
    - Maladie rénale chronique stades 4 ou 5, ou transplanté rénal
    E.4Principal exclusion criteria
    - - Participation to another trial uncluding the a use of a medicine
    - Active infection
    - Known allergty to anakinra
    - Neutropenia < 1000 /mm3
    - KCD≤ 3
    - Difficulties in understanding French
    - Analphabetism
    - Pregnenant women, parturient or breastfeeding women allaitent (Cf. CSP article L.1121-5)
    - Persons deprived of liberty by court or administrative decision Personnes, person subject of psychiatric healthcare (L. 3212-1 and L. 3213-1) and persons admitted in a social or healthcare facility for other purposes than research (Cf. CSP L.1121-6)
    - Adults subject of legal protection or unable to give teheir consent (Cf. CSP article L.1121-8)
    - Persons unafiliated to a social secutrity scheme or beneficiary of such a scheme (Cf. CSP article L.1121-8-1)
    - Participation à un autre essai comprenant l’administration d’un médicament
    - Infection active
    - Allergie connue à l’anakinra
    - Neutropénie < 1000 /mm3
    - MRC ≤ 3
    - Difficulté de compréhension du français
    - Analphabétisme
    - Femmes enceintes, parturientes ou mères qui allaitent (Cf. CSP article L.1121-5)
    - Personnes privées de liberté par une décision judiciaire ou administrative, les personnes faisant l'objet de soins psychiatriques en vertu des articles L. 3212-1 et L. 3213-1 et les personnes admises dans un établissement sanitaire ou social à d'autres fins que celle de la recherche (Cf. CSP article L.1121-6)
    - Personnes majeures faisant l'objet d'une mesure de protection légale ou hors d'état d'exprimer leur consentement (Cf. CSP article L.1121-8)
    - Personnes non affiliées à un régime de sécurité sociale ou bénéficiaires d'un tel régime (Cf. CSP article L.1121-8-1)
    E.5 End points
    E.5.1Primary end point(s)
    Pain variation between days of inclusion and D3 after beginning of treatment
    variation de la douleur entre le jour de l’inclusion et 3 jours après l’initiation du traitement.
    E.5.1.1Timepoint(s) of evaluation of this end point
    LSLV
    DVDP
    E.5.2Secondary end point(s)
    1. Anakinra efficacy
    o Dayly pain evolution during the 5 days after beginning of treatment: pain estimated on visual scale
    o Proportion of responding patients (improvement estimated at more than 50%) within 3 days after tretament initiation
    o Proportion of responding patients within 3 days after treatment initiation
    o Proportion of patients with attack resolution within 5 days after treatment initiation defined by pain improvement >80 % or scale evaluation < 20 mm
    o Delay to therapeutic response (improvement >50%
    o Total treatment duration
    o Number of relapse within the month
    o Time to first relapse
    Healthcare consumption : hospitalisation duration relater to gout attck, sick leave duration related to gout attack
    2. Anakinra tolerance
    o Incidence of reaction at the injection site
    o Incidence of neutropenia and thrombopenia
    o Mean value of neutropenia and thrombopénia
    o Incidences of sever infections
    o Incidence of any adverse event imputable to treatment
    o Incidnce of cardivascular envents and comorbidity decompensation
    Critères d’évaluation correspondants
    o Evolution quotidienne de la douleur dans les 5 jours après initiation du traitement : douleur estimée par EVA
    o Proportion de patients répondeurs (amélioration estimée à plus de 50%) dans les 3 jours après initiation du traitement.
    o Proportion de patients répondeurs dans les 3 jours après initiation du traitement
    o Proportion de patients avec une crise résolue dans les 5 jours après initiation du traitement. Résolution définie par une amélioration de la douleur > 80% ou une EVA < 20 mm. Crise résolue dans les 5 jours après initiation du traitement
    o Délai de réponse thérapeutique (amélioration > 50%)
    o Durée totale de traitement
    o Nombre de rechute de crise dans le mois
    o Délai à la première rechute
    Consommation de soins durant un mois : durée des hospitalisations en rapport avec la crise de goutte, durée d’arrêt de travail en rapport avec la crise de goutte
    o Incidence des réactions au point d’injection
    o Incidence des neutropénie et thrombopénie
    o Valeur moyenne des neutropénies et thrombopénies
    o Incidences des infections sévères
    o Incidences de tout effet secondaire imputable au traitement
    o Incidences des événements cardiovasculaires et des décompensations des comorbidités

    Evolution des comorbidités : HTA, dyslipidémie, diabète, syndrome métabolique (mesures cliniques et biologiques et estimation des variations entre inclusion et la fin de l’étude à M1 pour le bilan lipidique, glycémie à jeun, HbA1C, DFGe)
    E.5.2.1Timepoint(s) of evaluation of this end point
    LSLV
    DVDP
    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) 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 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) Yes
    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 concerned15
    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
    LSLV
    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 months25
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 44
    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 state234
    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 Decision2021-01-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-09
    P. End of Trial
    P.End of Trial StatusOngoing
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