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    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2022-002684-29
    Sponsor's Protocol Code Number:IP-001-21
    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:2023-01-04
    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 number2022-002684-29
    A.3Full title of the trial
    A Study of GlucoThera Plus for PeRitoneal DiAlysis in Children.
    Studio di Glucothera Plus nella dialisi peritoneale in età pediatrica.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of GlucoThera Plus for PeRitoneal DiAlysis in Children.
    Studio di Glucothera Plus nella dialisi peritoneale in età pediatrica.
    A.3.2Name or abbreviated title of the trial where available
    ASTRA
    ASTRA
    A.4.1Sponsor's protocol code numberIP-001-21
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/060/2022
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorIPERBOREAL PHARMA S.R.L.
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIPERBOREAL PHARMA S.R.L.
    B.5.2Functional name of contact pointNS
    B.5.3 Address:
    B.5.3.1Street AddressVia Piave 110/7
    B.5.3.2Town/ cityPescara
    B.5.3.3Post code65122
    B.5.3.4CountryItaly
    B.5.4Telephone number0852034834
    B.5.6E-maila.arduini@iperboreal.com
    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 No
    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 nameGlucothera Plus
    D.3.2Product code [N.A.]
    D.3.4Pharmaceutical form Solution for peritoneal dialysis
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraperitoneal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 14431-43-7
    D.3.9.2Current sponsor codeN.A.
    D.3.9.3Other descriptive nameD-glucose
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 541-15-1
    D.3.9.2Current sponsor codeN.A.
    D.3.9.3Other descriptive namelevocarnitine
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    End-Stage Renal Disease (ESRD)
    Malattia renale allo stadio terminale
    E.1.1.1Medical condition in easily understood language
    Renal disease
    Insufficienza renale
    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 21.0
    E.1.2Level PT
    E.1.2Classification code 10077512
    E.1.2Term End stage renal disease
    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
    The primary objective of this study is to demonstrate the safety of Glucothera Plus in the pediatric population.
    L'obiettivo primario è dimostrare la sicurezza di Glucothera Plus nella popolazione pediatrica.
    E.2.2Secondary objectives of the trial
    Efficacy parameters assessment (including restoration of carnitine levels).
    Valutazione dei parametri di efficacia (compreso il ripristino dei livelli di carnitina nel sangue).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible for this study, subjects must meet all of the following inclusion criteria:
    1. Male and female patients younger than 18 years old.
    2. Diagnosed with ESRD and in treatment with CAPD or APD for the last 6 months
    3. L-carnitine plasma level lower or equal to 30 nmol/ml
    4. Have not experienced peritonitis episodes in the last 3 months
    5. Dwell volume from 800 ml/m2 to 1200 ml/m2 body surface
    6. Provide the informed consent to participate in the study
    Saranno arruolati i pazienti che soddisfano tutti i seguenti criteri:
    1. Pazienti di sesso maschile e femminile di età inferiore a 18 anni.
    2. Diagnosi di ESRD e trattamento con CAPD o APD negli ultimi 6 mesi
    3. Livello di carnitina nel plasma inferiore o uguale a 30 nmol/ml
    4. Nessun episodio di peritonite negli ultimi 3 mesi
    5. Volume di riempimento compreso tra 800 e 1200 ml/m2 di superficie corporea.
    6. Fornitura del consenso informato di partecipazione allo studio
    E.4Principal exclusion criteria
    If any of the following criteria are met, subjects are not eligible for this study:
    1. Male and female patients 18 years old or older
    2. Subjects with reduced efficiency of peritoneal dialysis due to anatomic anomalies or intraperitoneal adesions
    3. Uncontrolled hyperphosphatemia
    4. Participation in a clinical trial with an investigational drug within one month prior start of study. Prior participation in this trial.
    5. Suspicion of drug abuse
    6. Severe pulmonary, cardiac or hepatic disease/insufficiency
    7. Clinically significant abnormal liver function test (Gamma-GT > 4 times the upper normal limit and/or transaminases AST and/or ALT > 3 upper normal limits)
    8. Any kind of malignancy
    9. Lack of appropriate caregiver support
    10. Impeding/major abdominal surgery
    11. Enrolment in another clinical trial involving medical or device based interventions during a) the 30 days before the screening or b) 5-times the half-life of the used investigational product (the longest period should be considered).
    12. Ipersensibility to Glucose, L-Carnitine and other Glucothera Plus components.
    13. Evidence of any condition that, according to the investigators’ judgment, could expose the subject to undue risk and/or prevent the subject from participating in the study procedures and/or potentially affecting the study quality data.
    14. Female patients who are pregnant or breast-feeding or women of childbearing potential
    not receiving adequate contraceptive methods.
    Non saranno arruolati i pazienti che soddisfano uno qualsiasi dei seguenti criteri:
    1. Pazienti di sesso maschile e femminile di età uguale o superiore a 18 anni
    2. Soggetti con efficienza ridotta della dialisi peritoneale dovuta ad anomalie anatomiche o adesioni intraperitoneali
    3. Iperfosfatemia incontrollata
    4. Partecipazione a uno studio clinico di sperimentazione farmacologica entro un mese prima dell'inizio del presente studio. Partecipazione pregressa al presente studio.
    5. Sospetto abuso di sostanze
    6. Malattia/insufficienza polmonare, cardiaca o epatica grave.
    7. Esame di funzionalità epatica significativamente anomalo sul piano clinico (gamma-GT > 4 volte il limite superiore di norma e/o transaminasi AST e/o ALT > 3 volte il limite superiore di norma)
    8. Malignità di qualsiasi tipo
    9. Supporto inadeguato da parte dell'accompagnatore
    10. Chirurgia addominale maggiore/ostacolante
    11. Arruolamento in altro studio clinico che prevede interventi di tipo medico o l'ausilio di dispositivi a) nei 30 giorni precedenti lo screening o b) in un periodo corrispondente a 5 volte l'emivita del prodotto sperimentale utilizzato (considerare il periodo più lungo).
    12. Ipersensibilità a glucosio, L-carnitina e altri componenti di Glucothera Plus.
    13. Evidenze di qualsiasi patologia che, nel parere degli sperimentatori, possa esporre il soggetto a rischi immotivati e/o che possa impedire la partecipazione del soggetto alle procedura di studio e/o che possa interferire con la qualità dei dati dello studio.
    14. Pazienti di sesso femminile in gravidanza o in allattamento o donne potenzialmente fertili con accesso inadeguato ai metodi contraccettivi.
    E.5 End points
    E.5.1Primary end point(s)
    The primary end-point is the Safety assessed on the basis of continuous adverse events reporting, including evaluation of blood pressure and body weight
    Valutazione della sicurezza sulla base della segnalazione continua degli eventi avversi e del rilevamento di pressione sanguigna e peso corporeo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    For whole study duration
    Per tutta la durata dello studio
    E.5.2Secondary end point(s)
    Residual kidney function at baseline and after 4 weeks; Carnitine plasma levels at screening, after 4 weeks run-in (at baseline) and after 4 weeks treatment.; Tolerability assessment, laboratory (blood chemistry and hematology); Net Peritoneal ultrafiltration (24 hours) at baseline and after 4 weeks; Diuresis (24 hours urinary volume) daily at baseline and after 4 weeks; Peritoneal Equilibration Test at baseline and after 4 weeks; Weekly Kt/V urea at baseline and after 4 weeks
    Funzionalità renale residua al basale e a 4 settimane; Livelli di carnitina nel plasma allo screening, dopo le quattro settimane di inserimento (basale) e dopo 4 settimane di trattamento.; Valutazione della tollerabilità, esami di laboratorio (ematochimica ed ematologia); Ultrafiltrazione peritoneale netta (24 ore) al basale e a 4 settimane; Diuresi giornaliera (volume urinario su 24 ore) al basale e dopo 4 settimane; Test di equilibrazione peritoneale (Peritoneal Equilibration Test, PET) al basale e a 4 settimane; Kt/V (urea) settimanale al basale e a 4 settimane
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visit 2 (treatment start) and visit 3 (end of treatment, 28 days after treatment start); Visit 1 (screening), visit 2 (treatment start) and visit 3 (end of treatment, 28 days after treatment start); Visit 2 (treatment start), visit 3 (end of treatment, 28 days after treatment start) and visit 4 (end of follow-up, 28 days after end of treatment); Visit 2 (treatment start) and visit 3 (end of treatment, 28 days after treatment start); Visit 2 (treatment start) and visit 3 (end of treatment, 28 days after treatment start); Visit 2 (treatment start) and visit 3 (end of treatment, 28 days after treatment start); Visit 2 (treatment start) and visit 3 (end of tratment, 28 days after treatment start)
    Visita 2 (inizio del trattamento) e visita 3 (fine del trattamento, 28 giorni dall'inizio del trattamento); Visita 1 (screening), visita 2 (inizio del trattamento) e visita 3 (fine del trattamento, 28 giorni dall'inizio del trattamento); Visita 2 (inizio del trattamento), visita 3 (fine del trattamento, 28 giorni dall'inizio del trattamento) e visita 4 (fine della fase di follow-up, 28 giorni dopo la fine del trattamento); Visita 2 (inizio del trattamento) e visita 3 (fine del trattamento, 28 giorni dall'inizio del trattamento); Visita 2 (inizio del trattamento) e visita 3 (fine del trattamento, 28 giorni dall'inizio del trattamento); Visita 2 (inizio del trattamento) e visita 3 (fine del trattamento, 28 giorni dall'inizio del trattamento); Visita 2 (inizio del trattamento) e visita 3 (fin
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 Information not present in EudraCT
    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 months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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: 5
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 15
    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 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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Minors
    Minori
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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)
    After the study patients come back to their standard perioteal dyalisis treatment, with marketed peritoneal dialisis solution and according to nephrologist prescription
    I pazienti che concludono la sperimentazione tornano al trattamento di dialisi peritoneale standard, con soluzioni per dialisi in commercio e secondo la prescrizione nefrologica
    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 Decision2023-07-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-02-14
    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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