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    Summary
    EudraCT Number:2017-000826-36
    Sponsor's Protocol Code Number:P160905J
    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:2018-03-21
    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 number2017-000826-36
    A.3Full title of the trial
    Efficacy and safety of immunoglobulin associated with rituximab versus rituximab alone in Childhood-Onset steroid-dependent nephrotic syndrome
    Evaluation de l'efficacité et de la tolérance de l'injection d'immunoglobulines en association au rituximab par rapport au rituximab seul dans le syndrome néphrotique corticodépendant à début pédiatrique
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of immunoglobulins in pediatric early-onset corticosteroid nephrotic syndrome
    Efficacité des immunoglobulines dans le syndrome néphrotique corticodépendant à début pédiatrique
    A.3.2Name or abbreviated title of the trial where available
    RITUXIVIG
    A.4.1Sponsor's protocol code numberP160905J
    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 SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    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 supportDGOS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.5.2Functional name of contact pointDRCI Hôpital St Louis
    B.5.3 Address:
    B.5.3.1Street Address 1 av. Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.6E-mailsophie.courtial-destembert@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 Privigen
    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.3.1Product namePrivigen
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Yes
    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 INNImmunoglobulines humaines normales
    D.3.9.3Other descriptive namePrivigen 100 mg/ml solution pour perfusion
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100mg/ml
    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) Yes
    D.3.11.7Plasma derived medicinal product Yes
    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
    Childhood-Onset steroid-dependent nephrotic syndrome
    syndrome néphrotique corticodépendant à début pédiatrique
    E.1.1.1Medical condition in easily understood language
    pediatric early-onset corticosteroid nephrotic syndrome
    syndrome néphrotique corticodépendant à début pédiatrique
    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10029164
    E.1.2Term Nephrotic syndrome
    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 assess the effect of a single infusion of rituximab followed by immunoglobulin injections (once a month during 5 months) on the occurrence of the first relapse within 24 months following the initiation of treatment in patient with childhood onset Steroid-dependent nephrotic syndrome compared to a single infusion of rituximab.
    Évaluer l'effet d'une perfusion unique de rituximab suivie d'injections d'immunoglobulines (une fois par mois pendant 5 mois) sur la survenue de la première rechute dans les 24 mois suivant l'initiation du traitement chez les patients atteints de syndrome néphrotique corticodépendant (SNCD) à début pédiatrique comparé à une perfusion unique de rituximab.
    E.2.2Secondary objectives of the trial
    1/ To assess the impact of a treatment with rituximab followed by intravenous immunoglobulin injection compared to a single infusion of rituximab on:
    - Time to first relapse
    - Number of relapse over a 24 months follow-up
    - Cumulative amount of corticosteroid over a 24 months follow-up
    - Initiation of a new immunosuppressive therapy
    2/ To assess the demographics, clinical and biological risk factors of relapse.
    3/ To access the adverse events in each arm.
    1/Evaluer l'impact d'un traitement par rituximab suivi d'injections intraveineuses d'immunoglobulines par rapport à une perfusion unique de rituximab sur :
    - le délai de la première rechute ;
    - le nombre de rechutes pendant 24 mois ;
    - la dose cumulée de corticoïdes sur 24 mois ;
    - l'initiation d'un nouveau traitement immunosuppresseur.
    2/Identifier les facteurs de risque démographiques, cliniques et biologiques de rechute.
    3/ Surveiller la survenue d'éventuels événements indésirables dans chaque bras.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Childhood onset nephrotic syndrome (first flair at age> 2 years and <18 years)
    - Steroid-dependent:
    *Patient with at least 2 relapses confirmed during the decay of corticosteroids or within 2 weeks following steroids discontinuation.
    *Patient with at least 2 relapses including one under steroid-sparing agent (MMF, Calcineurin inhibitors, cyclophosphamide) or following treatment withdrawal.
    - or with frequent relapses:
    *2 or more relapses within 6 months after initial remission or 4 or more relapses within any 12-month period.
    - with a relapse within 3 months prior to inclusion
    - In remission: Protein-over-creatinine ratio <- 0.2g/g (<- 0.02g/mmol)
    - syndrome néphrotique idiopathique à début pédiatrique (première poussée à un âge> 2 ans et <18 ans) ;
    - corticodépendant :
    *patient qui a déjà eu au moins deux rechutes confirmées lors de la baisse de la corticothérapie ou dans les 2 semaines suivant l'arrêt
    *patient qui a déjà eu au moins deux rechutes dont une sous traitement qui évite l'utilisation des stéroïdes (MMF, inhibiteur de la calcineurine, cyclophosphamide) ou suivant l'arrêt de ce traitement
    - ou avec des rechutes fréquentes :
    *2 rechutes ou plus dans les 6 mois suivant la rémission initiale ou 4 rechutes ou plus sur une période de 12 mois
    - avec une rechute dans les 3 mois précédent l'inclusion ;
    - en rémission : rapport protéine sur créatinine inférieur ou égal 0.2g/g de créatinine (inférieur ou égal 0.02g/mmol).
    E.4Principal exclusion criteria
    - Patients with steroid-resistant nephrotic syndrome;
    - Patients with genetic nephrotic syndrome;
    - Patients previously treated with rituximab;
    - Patients with no affiliation to a social security scheme (beneficiary or legal);
    - Prior hepatitis B infection;
    - Pregnancy or breastfeeding.
    - Patients with hyperprolinaemia,
    - Known hypersensitivity to one of the study medication,
    - Scheduled and not postponable injection of live attenuated vaccine
    - patients présentant un syndrome néphrotique corticorésistant ;
    - patients souffrant de syndrome néphrotique génétique ;
    - patients ayant déjà reçu un traitement par rituximab ;
    - patients sans affiliation à un régime de sécurité sociale (bénéficiaire ou légal) ;
    - patients avec un antécédent d'infection par le virus de l'hépatite B ;
    - femmes enceintes ou allaitement maternel ;
    - patients atteints d'hyperprolinémie ;
    - hypersensibilité connue à l'un des traitements de l'étude ;
    - injection planifiée et non reportable d'un vaccin vivant atténué
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is the occurrence of the first relapse within 24 months following the initiation of treatment.
    Relapse is defined as:
    - A protein to creatinine ratio of 2g/g of creatinine (0.2 g/mmol) or higher.

    Secondary assessment criterion :
    - Time to first relapse;
    - Number of relapse over a 24 months follow-up;
    - Cumulative amount of corticosteroid over a 24 months' follow-up;
    - Initiation of a new immunosuppressive therapy
    - Adverse events during the study period such as infectious complications, treatment tolerance, nausea, neutropenia
    Le critère d'évaluation principal est la survenue d'une première rechute dans les 24 mois suivant l'initiation du traitement.
    La rechute est définie comme suit :
    - un rapport protéine/créatinine de 2g/g de créatinine (0,2g/mmol) ou plus

    Evaluations secondaires :

    - le délai de la première rechute ;
    - le nombre de rechutes pendant 24 mois ;
    - la dose cumulée de corticoïdes sur 24 mois ;
    - l'initiation d'un nouveau traitement immunosuppresseur.
    - la survenue d'éventuels événements indésirables dans chaque bras.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 months
    24 mois
    E.5.2Secondary end point(s)
    - Time to first relapse from the beginning of treatment;
    - Number of relapse occurring during the 24 months' follow-up period;
    - Cumulative amount of corticosteroid taken during the 24 months' follow-up: it is calculated as the cumulative dose of corticosteroid for the enrolment episode plus the cumulative dose of corticosteroid for each relapse;
    - Adverse events during the study period such as infectious complications, treatment tolerance, nausea, neutropenia
    - le délai de la première rechute ;
    - le nombre de rechutes pendant 24 mois ;
    - la dose cumulée de corticoïdes sur 24 mois ;
    - événements indésirables dans chaque bras.
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 months
    24 mois
    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) 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 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) Yes
    E.8.2.2Placebo No
    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 concerned20
    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 Yes
    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 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 Yes
    F.1.1Number of subjects for this age range: 80
    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: 40
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 40
    F.1.2Adults (18-64 years) No
    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 Yes
    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 state90
    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)
    Support in the care
    Prise en charge dans le cadre du soin
    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 Decision2018-05-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-24
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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