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    The EU Clinical Trials Register currently displays   41201   clinical trials with a EudraCT protocol, of which   6744   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2013-003826-10
    Sponsor's Protocol Code Number:EAGLE
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-10-28
    Trial results View 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 number2013-003826-10
    A.3Full title of the trial
    EVALUATING THE MORPHOFUNCTIONAL EFFECTS OF ECULIZUMAB THERAPY IN PRIMARY MEMBRANOPROLIFERATIVE GLOMERULONEPHRITIS:
    A PILOT, SINGLE ARM STUDY IN TEN PATIENTS WITH PERSISTENT HEAVY PROTEINURIA
    TERAPIA DELLA GLOMERULONEFRITE MEMBRANOPROLIFERATIVA PRIMITIVA CON UN INIBITORE DEL COMPLEMENTO (ECULIZUMAB): STUDIO PILOTA, CON UN SINGOLO BRACCIO, IN 10 PAZIENTI CON PROTEINURIA GRAVE PERSISTENTE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ECULIZUMAB THERAPY IN PRIMARY MEMBRANOPROLIFERATIVE GLOMERULONEPHRITIS
    TERAPIA DELLA GLOMERULONEFRITE MEMBRANOPROLIFERATIVA PRIMITIVA CON UN INIBITORE DEL COMPLEMENTO (ECULIZUMAB)
    A.3.2Name or abbreviated title of the trial where available
    Eculizumab in primary MPGN
    Eculizumab nella GNMP primaria
    A.4.1Sponsor's protocol code numberEAGLE
    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 SponsorIRCCS- Mario Negri Institute
    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 supportIRCCS - Mario Negri Institute
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportAlexion Pharmaceuticals inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIRCCS - Mario Negri Institute
    B.5.2Functional name of contact pointLab. Regulatory Affairs for CT
    B.5.3 Address:
    B.5.3.1Street Addressvia G. Camozzi, 3
    B.5.3.2Town/ cityRanica BG
    B.5.3.3Post code24020
    B.5.3.4CountryItaly
    B.5.4Telephone number00390354535307
    B.5.5Fax number00390354535371
    B.5.6E-mailpaola.boccardo@marionegri.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 Soliris
    D.2.1.1.2Name of the Marketing Authorisation holderAlexion Pharma Italy
    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.3.1Product nameSoliris
    D.3.4Pharmaceutical form Concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    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 INNECULIZUMAB
    D.3.9.1CAS number 219685-50-4
    D.3.9.4EV Substance CodeSUB25187
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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
    Membranoproliferative glomerulonephritis
    Glomerulonefrite membranoproliferativa
    E.1.1.1Medical condition in easily understood language
    Membranoproliferative glomerulonephritis
    Glomerulonefrite membranoproliferativa
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate whether Eculizumab therapy may reduce 24 hour proteinuria, considered as a continuous variable, at 6 months (week-24) and 12 months (week-48) compared to baseline
    Valutare se la terapia con Eculizumab riduce la proteinuria delle 24 ore, considerata come variabile continua, a 6 e 12 mesi rispetto al basale.
    E.2.2Secondary objectives of the trial
    - To assess whether Eculizumab therapy may achieve persistent, either complete or partial, remission of the nephrotic syndrome.
    - To assess the effect of Eculizumab therapy on relapses of nephrotic syndrome.
    - To assess the effect of Eculizumab therapy on clinical and laboratory parameters and renal functional parameters
    - To assess the effect of Eculizumab therapy on markers of complement activity (C3, C4, C3a, C5a, Bb and sC5b9) and immunohistochemical (C3, C5b-9, IgG, IgA, IgM, C4d, C1q, kappa light chain, lambda light chain, CD21, C5aR), structural and ultrastructural changes associated with remission of proteinuria in patients with evidence of complete or partial remission of the nephrotic syndrome- To assess the safety profile and the cost/effectiveness of the Eculizumab treatment-To evaluate biomarkers (see table) to be tested in case of significant treatment effect on the primary efficacy variable.
    - Valutare se la terapia con Eculizumab può determinare una remissione persistente, completa o parziale della sindrome nefrosica
    - Valutare l’effetto della terapia con Eculizumab sulla remissione della sindrome nefrosica
    - Determinare l’effetto dell’Eculizumab sui parametri clinici e di laboratorio
    - Determinare l’effetto dell’Eculizumab sui parametri di funazionalità renale
    - Valutare gli effetti della terapia con Eculizumab sui marker di attività del complemento (C3, C4, C3a, C5a, Bb e sC5b9)
    - Valutare le variazioni, strutturali e ultrastrutturali, nei parametri immunoistochimici (C3, C5b-9, IgG, IgA, IgM, C4d, C1q, kappa light chain, lambda light chain, CD21, C5aR)
    - Valutare il profilo di sicurezza e il rapporto costo/beneficio della terapia con Eculizumab
    - Valutare alcuni biomarker plasmatici ed urinari (vedi tabella allegata al protocollo)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Biopsy-proven primary MPGN
    - Creatinine clearance >20 ml/min per 1.73m2
    - 24-hour proteinuria persistently exceeding 3,5g in adults or exceeding 40mg/h/m2 in children (or exceeding 2mg protein/mg creatinine in children spot urine samples)
    - Persistently low C3 levels in at least two consecutive evaluations
    - Persistently high sC5b9 levels (>1000 ng/ml) in at least two previous consecutive evaluations
    - Written informed consent (by parents or tutors if underage)
    - MPGN primaria diagnosticata su base bioptica
    - Clearance della creatinina >20 ml/min per 1.73m2
    - Proteinuria delle 24 ore persistentemente >3.5 g negli adulti o > 40 mg/h/m2 (o superiore a 2mg proteine/mg creatinina nello spot urinario) nei bambini
    - Livelli di C3 persistentemente bassi in almeno due valutazioni successive
    - Livelli di sC5b9 persistentemente alti (>1000 ng/ml) in almeno due valutazioni successive
    - Consenso informato scritto (se paziente minorenne consenso dei genitori o del tutore)
    E.4Principal exclusion criteria
    - Age > 75 years
    - Secondary MPGN (evidence of infection, immunological disease including vasculitis, systemic diseases and proliferative disorders)
    - Evidence at kidney biopsy evaluation of severe chronic histological changes that very unlikely could benefit of eculizumab therapy
    - Concomitant steroid or immunosoppressive therapy for immuno-mediated disease
    - Pregnancy or lactating
    - Childbearing potential without effective contraception
    - Any clinically relevant condition that might affect completion of the study participation and/or confound study results
    - Inability to understand the potential risks and benefits of the study
    - Legal incapacity
    - Età > 75 anni
    - MPGN secondaria (evidenza di infezione, malattie immunologiche tra cui vasculiti, malattie sistemiche e disordini proliferativi)
    - Presenza valutata su base bioptica di alterazioni istologiche severe sulle quali la terapia con Eculizumab non può essere efficace
    - Terapia concomitante con steroidi o immunosoppressivi a causa di una malattia autoimmune
    - Gravidanza o allattamento
    - Donne potenzialmente fertili che non utilizzano un sistema contraccettivo scientificamente valido
    - Qualsiasi condizione che possa compromettere la partecipazione allo studio e/o interferire sui risultati
    - Incapacità di comprendere i potenziali rischi e benefici dello studio
    - Incapacità legale
    E.5 End points
    E.5.1Primary end point(s)
    Reduction in 24 hour proteinuria, considered as a continuous variable
    Riduzione della proteinuria delle 24 ore.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At basal and at 1,12,24,36,48 weeks.
    Al basale e alle settimane 1, 12, 24 ,36 e 48.
    E.5.2Secondary end point(s)
    1) Complete or partial remission of the nephrotic syndrome
    2) Normalization (reduction to <303 ng/ml) of sC5b-9 plasma levels
    Normalization in plasma levels of other components of the complement system including C3, C4, C3a, C5a, and Bb
    3) Amelioration of kidney function/perfusion parameters including measured glomerular filtration rate (GFR); albumin, IgG, sodium and potassium fractional clearance; renal resistivity index
    1) Remissione completa o parziale della sindrome nefrosica
    2) Normalizzazione (<303 ng/ml) dei livelli plasmatici di sC5b-9
    Normalizzazione dei livelli plasmatici di altri componenti del sistema del complemento tra i quali C3, C4, C3a, C5a, e Bb.
    3) Miglioramento dei parametri di funzionalità renale tra cui GFR, clearance frazionata di albumina, IgG, sodio e potassio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Alla fine dello studio
    2) Al basale e alle settimane 2,3,4,8,12,16,20,24,28,32,36,40,44 e 48.
    3) Al basale e alle settimane 1, 24 e 48.
    1) At the end of the study.
    2) At basal and at 2,3,4,8,12,16,20,24,28,32,36,40,44, 48 weeks.
    3) At basal and at 1,24, 48 weeks.
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    intrapaziente
    intra-patient
    E.8.2.4Number of treatment arms in the trial1
    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 concerned10
    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 years2
    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: 6
    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: 2
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 4
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 4
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    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)
    In the case of a good response to therapy with eculizumab treatment after the first year of the administration of the drug will be continued for compassionate use, and blood and urine tests, tests of complement activation, glomerular filtration rate and renal ultrasonography will be repeated every six months.
    Nel caso di una buona risposta alla terapia con Eculizumab dopo il primo anno di trattamento la somministrazione del farmaco verrà proseguita per uso compassionevole e ogni sei mesi verranno ripetuti gli esami ematici e urinari, i test di attivazione del complemento, il filtrato glomerulare e l’ecografia renale.
    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 Decision2014-01-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-12-19
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