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    Summary
    EudraCT Number:2012-004326-16
    Sponsor's Protocol Code Number:FARM93J3CJ
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-11-06
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2012-004326-16
    A.3Full title of the trial
    A Prospective Randomized study to Optimize Prednisone therapy for relapses of Idiopathic NEphrotic syndrome in children (PROPINE study)
    1. Studio prospettico randomizzato per ottimizzare la terapia con prednisone delle recidive della sindrome nefrosica idiopatica dei bambini
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prospective study to improve therapy with prednisone for relapse of idiopathic nephrotic syndrome in children
    Studio prospettico al fine di migliorare la terapia con Prednisone in seguito alla ripresentazione della sindrome nefrosica idiopatica nei bambini
    A.3.2Name or abbreviated title of the trial where available
    PROPINE
    PROPINE
    A.4.1Sponsor's protocol code numberFARM93J3CJ
    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 SponsorOSPEDALE PEDIATRICO BAMBINO GESU' DI ROMA
    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 supportAIFA (bandi per la ricerca indipendente)
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOspedale Pediatrico Bambino Gesù
    B.5.2Functional name of contact pointNefrologia e Dialisi
    B.5.3 Address:
    B.5.3.1Street Addressantonio.gargiulo@opbg.net
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00162
    B.5.3.4CountryItaly
    B.5.4Telephone number333-8424760
    B.5.6E-mailantonio.gargiulo@opbg.net
    D. IMP Identification
    D.IMP: 1
    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.2.1.2Country 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.3.4Pharmaceutical 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.3.9.1CAS number 53-03-2
    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 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.2.1.2Country 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.3.4Pharmaceutical 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.3.9.1CAS number 53-03-2
    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
    At least one relapse of INS in the last year, normal renal function (creatinine clearance> 90 mL/min/1.73 m2); INS in remission at the time of enrollment (if the patient has recently had a relapse can be enrolled only after finishing therapy with PDN or be returned to its usual maintenance dose)
    Almeno una recidiva di INS nell’ultimo anno; Funzione renale normale (clearance della creatinina > 90 ml/min/1.73 m2); INS in remissione al momento dell’arruolamento (se il paziente ha avuto recentemente una recidiva può essere arruolato solo dopo aver terminato la terapia con PDN oppure deve essere ritornato alla sua dose di mantenimento abituale)
    E.1.1.1Medical condition in easily understood language
    Patients with relapse of idiopathic nephrotic syndrome
    Pazienti con Sindrome nefrosica idiopatica recivante
    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    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
    The primary aim of the study is to test the optimal modalities of PDN treatment for relapses of INS and to show the superiority of one of the two proposed PDN protocols.
    L'obiettivo primario dello studio è quello di verificare le modalità migliori di trattamento con PDN per le recidive di INS e mostrare la superiorità di uno dei due protocolli con PDN proposti.
    E.2.2Secondary objectives of the trial
    The secondary aims of the study are: - to investigate the safety of the two PDN treatment schedules; to evaluate the prognostic value of transient, self-remitting proteinuria (1+ to 3+) during follow-up in predicting incipient relapses of INS; - to evaluate the prognostic value of “trace” proteinuria (as opposed to “0” proteinuria) in predicting incipient relapses of INS; - to evaluate the prognostic value of the time to remission (days) after re-induction with PDN in predicting the rapidity of subsequent relapses. These secondary aims will allow elaboration of future trials aimed at reducing the total burden of steroid therapy by treating preventively with shorter courses of PDN patients that are at high risk of imminent relapse.
    Gli obiettivi secondari dello studio sono: - Valutare la sicurezza dei due schemi di trattamento con PDN; Valutare il valore prognostico della proteinuria (1 + a 3 +) transitoria, auto-remittente durante il follow-up nel predire ricadute incipienti di INS; - Valutare il valore prognostico della `traccia` di proteinuria (al contrario di proteinuria `0`) nel predire ricadute incipienti di INS; - Valutare il valore prognostico del tempo di remissione (giorni) dopo la re-induzione con PDN per predire la rapidità di successive ricadute. Questi obiettivi secondari permetteno l`elaborazione di studi futuri volti a ridurre l`onere complessivo della terapia steroidea attraverso il trattamento preventivo con cicli più brevi i pazienti PDN che sono ad alto rischio di ricaduta imminente.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Aged between 3 and 17 years at enrollment • At least one recurrence of INS in the last year • normal renal function (creatinine clearance> 90 mL/min/1.73 m2) • INS in remission at the time of enrollment (if the patient has recently had a relapse can be enrolled only after finishing therapy with PDN or be returned to its usual maintenance dose)
    • Età compresa tra 3 e 17 anni al momento dell’arruolamento • Almeno una recidiva di INS nell’ultimo anno • Funzione renale normale (clearance della creatinina &gt; 90 ml/min/1.73 m2) • INS in remissione al momento dell’arruolamento (se il paziente ha avuto recentemente una recidiva può essere arruolato solo dopo aver terminato la terapia con PDN oppure deve essere ritornato alla sua dose di mantenimento abituale)
    E.4Principal exclusion criteria
    • Patients with comorbidities not related to the INS • Patients with steroid-resistant INS • Patients who achieved remission in more than 21 days during the last relapse (pcs at risk of secondary steroid resistance) • Patients who have fallen in the previous year while receiving therapy with PDN higher dose of 30 mg/m2 on alternate days (severe steroid dependency, which may require the addition of an immunosuppressant drug) • Patients who are on maintenance therapy with PDN at the higher dose of 15 mg/m2 every other day • Patients receiving other immunosuppressive drugs (should have been suspended for at least 3 months) • Patients treated with antihypertensive drugs
    • Pazienti con comorbidità non correlata alla INS • Pazienti con INS steroido resistente • Pazienti che hanno raggiunto la remissione in più di 21 giorni durante l’ultimo relapse (pz a rischio di steroido resistenza secondaria) • Pazienti che sono ricaduti nell’anno precedente mentre ricevevano una terapia con PDN a dosaggio maggiore di 30 mg/m2 a giorni alterni (grave steroido dipendenza che può richiedere l’aggiunta di un farmaco immunosoppressore) • Pazienti che sono in terapia di mantenimento con PDN alla dose maggiore di 15 mg/m2 a giorni alterni • Pazienti che assumono altri farmaci immunosoppressori (devono essere stati sospesi da almeno 3 mesi) • Pazienti in terapia con farmaci antipertensivi
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome of the study was the proportion of patients in remission at 6 months after treatment. Is also evaluated the relative toxicity of the PDN in the two protocols.
    L’outcome primario dello studio è la percentuale di pazienti in remissione dopo 6 mesi dal trattamento. Verrà valutata anche la tossicità relativa al PDN nei due protocolli.
    E.5.1.1Timepoint(s) of evaluation of this end point
    six months
    6 mesi
    E.5.2Secondary end point(s)
    Secondary outcomes include: - Changes in blood pressure - Changes in body mass index and weight - Frequency of infections and other adverse events. Serious adverse events will be recorded from the time of obtaining informed consent throughout the study period. Subjects who will discontinue the study prematurely will continue to be monitored for safety where possible (although they will probably receive PDN as their standard treatment for INS, or will be switched to more intensive immunosuppressive medications, which are more likely to be responsible for new adverse events). - Frequency of borderline dipsticks after remission (`trace`) - Frequency of self-remitting proteinuria after remission.
    Gli endpoint secondari includono: - Variazioni della pressione sanguigna - Variazione indice di massa corporea e il peso - Frequenza delle infezioni e altri eventi avversi. Gli eventi avversi gravi saranno registrati a partire dal momento in cui è stato ottenuto il consenso informato per tutto il periodo di studio. I soggetti che interromperanno prematuramente lo studio saranno monitorati per la sicurezza, se possibile (anche se probabilmente riceveranno PDN come trattamento standard per INS, o passeranno a farmaci immunosoppressivi più intensivi, che hanno una maggiore probabilità di essere responsabili di nuovi eventi avversi). - Frequenza di dipsticks borderline dopo remissione (`traccia`) - Frequenza di proteinuria auto-remittente dopo la remissione.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months
    12 mesi
    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 No
    E.8.1.6Cross over Yes
    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
    Trattamento standard
    Standard therapy
    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 concerned12
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months42
    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: 126
    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: 63
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 63
    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 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 state126
    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)
    Initially, all patients in both treatment arms, will receive the same induction therapy equal to 60 mg/m2 PDN os x (max dose 60 mg) divided in two daily doses of up to 7 days after remission
    Inizialmente tutti i pazienti, in entrambi i bracci di trattamento, riceveranno la stessa terapia di induzione pari a 60 mg/m2 di PDN x os (dose max 60 mg) divisi in due dosi giornaliere fino a 7 giorni dopo la remissione.
    Successivamente i pazienti randomizzati nel braccio “short” riceveranno 18 “full doses” di PDN a giorni alterni. “Full dose” per un peso corporeo compreso tra 10 e 40 Kg = [peso in Kg + 10]; peso corporeo superiore a 40 Kg = 50 mg.
    I pazienti randomizzati nel bra
    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 Decision2012-09-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-20
    P. End of Trial
    P.End of Trial StatusOngoing
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