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    Summary
    EudraCT Number:2011-004301-24
    Sponsor's Protocol Code Number:THEONEstudyreftrial(ONErgt11)
    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:2013-08-14
    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 number2011-004301-24
    A.3Full title of the trial
    The ONE Study: A Unified Approach to Evaluating Cellular Immunotherapy in Solid Organ Transplantation – Reference Group Trial
    Studio The ONE: approccio unificato per valutare l'immunoterapia cellulare nel trapianto d'organo - studio sul gruppo di riferimento
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The ONE Study: A Unified Approach to Evaluating Cellular Immunotherapy in Solid Organ Transplantation – Reference Group Trial
    studio UNO: un approccio unificato per valutare l'immunoterapia cellulare nel trapianto di organo solido
    A.3.2Name or abbreviated title of the trial where available
    ONErgt11
    ONErgt11
    A.4.1Sponsor's protocol code numberTHEONEstudyreftrial(ONErgt11)
    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 SponsorFree State of Bavaria, represented by the University of Regensburg, represented by Prof. Edward K. Gessler
    B.1.3.4CountryGermany
    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 supportEuropean Commission
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital Regensburg
    B.5.2Functional name of contact pointClinical Study Center Surgery
    B.5.3 Address:
    B.5.3.1Street AddressFranz-Josef-Strauss-Allee 11
    B.5.3.2Town/ cityRegensburg
    B.5.3.3Post code93053
    B.5.3.4CountryGermany
    B.5.4Telephone number+499419444895
    B.5.5Fax number+499419446772
    B.5.6E-mailtheonestudy@klinik.uni-regensburg.de
    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 Simulect
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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 Powder and solvent 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 INNBasiliximab
    D.3.9.1CAS number 179045-86-4
    D.3.9.3Other descriptive nameBASILIXIMAB
    D.3.9.4EV Substance CodeSUB12468MIG
    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 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 No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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.3.1Product nameMycophenolate mofetil
    D.3.4Pharmaceutical form Tablet and solvent for rectal suspension
    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 INNMycophenolate mofetil
    D.3.9.1CAS number 115007-34-6
    D.3.9.3Other descriptive nameMYCOPHENOLATE MOFETIL
    D.3.9.4EV Substance CodeSUB03360MIG
    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: 3
    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.3.1Product namePrednisolone
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    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 INNPREDNISOLONE
    D.3.9.1CAS number 50-24-8
    D.3.9.4EV Substance CodeSUB10018MIG
    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: 4
    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.3.1Product namePrednisolone
    D.3.4Pharmaceutical form Powder and solution for solution for injection
    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 INNPREDNISOLONE
    D.3.9.1CAS number 50-24-8
    D.3.9.4EV Substance CodeSUB10018MIG
    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: 5
    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.3.1Product nameTacrolimus
    D.3.4Pharmaceutical form Capsule, hard
    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 INNTACROLIMUS
    D.3.9.1CAS number 104987-11-3
    D.3.9.4EV Substance CodeSUB10797MIG
    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: 6
    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.3.1Product nameMycophenolic acid
    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 INNMYCOPHENOLIC ACID
    D.3.9.1CAS number 24280-93-1
    D.3.9.4EV Substance CodeSUB09098MIG
    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
    Kidney allograft rejection following living-donor renal transplantation.
    rigetto di trapianto renale conseguente a trapianto da donatore vivente
    E.1.1.1Medical condition in easily understood language
    Kidney graft rejection in patients receiving a kidney transplant from a living organ donor.
    rigetto del trapianto renale in pazienti che ricevono un trapianto di rene da donatore vivente
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10051366
    E.1.2Term Kidney graft dysfunction
    E.1.2System Organ Class 100000004863
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10049581
    E.1.2Term Graft rejection episode
    E.1.2System Organ Class 100000004870
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10050436
    E.1.2Term Prophylaxis against renal transplant rejection
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10069030
    E.1.2Term Graft failure
    E.1.2System Organ Class 100000004863
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10038297
    E.1.2Term Rejection acute renal
    E.1.2System Organ Class 100000004870
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10021510
    E.1.2Term Immunosuppression NOS
    E.1.2System Organ Class 100000004870
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10038299
    E.1.2Term Rejection chronic renal
    E.1.2System Organ Class 100000004863
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10066543
    E.1.2Term Acute allograft rejection
    E.1.2System Organ Class 100000004870
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To confirm the rate of acute kidney graft rejection in the study population under standard immunosuppressive therapy in order to corroborate historical renal transplantation statistics and generate reference ranges for future clinical research within The ONE Study.

    The Reference Group Trial is the first clinical trial planned within the context of The ONE Study, an international, non-commercial research project that ultimately aims in subsequent trials to test several alternative GMP cell products as adjunct immunosuppressive treatments in kidney transplantation. Future trials will assess whether immunoregulatory cell infusion could allow for a reduction in the use of pharmacological maintenance therapy in transplant recipients and alleviate the drawbacks associated with traditional immunosuppressive agents.
    confermare il tasso di rigetto acuto del trapianto renale studiando la popolazione in trattamento con terapia standard immunosoppressiva, al fine di supportare le statistiche esistenti di trapianto renale e creare linee guida per la futura ricerca clinica nell'ambito dello studio ONE.
    Lo studio sul “Gruppo di Riferimento” è il primo trial clinico previsto nell'ambito dello studio ONE, un progetto di ricerca internazionale, non commerciale
    che mira, in ultima analisi, nel corso degli studi successivi a testare diversi
    prodotti alternativi cellulari (GMP) come coadiuvante dei trattamenti immunosoppressivi nel trapianto di rene. Studi futuri valuteranno se
    infusioni di cellule immunomodulanti potrebbero consentire una riduzione nell'uso della terapia farmacologica di mantenimento nei pazienti trapiantati e
    alleviare gli inconvenienti legati ai tradizionali agenti immunosoppressivi
    E.2.2Secondary objectives of the trial
    The Reference Group Trial will also measure various clinical, immunological and health-economic parameters to generate reference ranges for future cell therapy studies within The ONE Study project.
    An Immune Monitoring Subpr. will use scientific lab. assays to investigate the progression of the immunological response in trial patients by measuring functional and molecular correlates of immune reactivity. Results will be used as a reference data set for the future study "The ONE Study cell therapy"
    Lo studio del “Gruppo di Riferimento” misurerà anche i diversi parametri clinici, immunologici e salute-economici di riferimento per generare range per futuri studi di terapia cellulare all'interno dello studio THE ONE.
    Un sottoprogetto di Monitoraggio Immunitario utilizzerà test di lab. scient. per indagare la progressione della risposta immunologica dei pazienti in studio misurando la funzionalità e le correlazioni molecolari della reattività immunitaria.
    I risultati saranno utilizzati per il futuro studio “THE ONE- terapia cellulare” .
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The main inclusion criteria for trial patients (organ recipients) are:

    • Chronic renal insufficiency necessitating kidney transplantation and approved to receive a primary kidney allograft from a living donor
    • Aged at least 18 years
    • Signed and dated written informed consent.
    •insufficienza renale cronica che richiede il trapianto di rene e che sia
    approvato per ricevere un trapianto di rene da un donatore vivente
    •Età maggiore di 18 anni
    •Consenso informato datato e firmato
    E.4Principal exclusion criteria
    The main exclusion criteria for trial patients (organ recipients) are:

    • Patient has previously received, or is scheduled to receive, any tissue or organ transplant other than the planned kidney graft
    • Known sensitivity to tacrolimus, mycophenolate or corticosteroids
    • Genetically identical to the prospective organ donor at the HLA loci
    • PRA grade > 40% within 6 months prior to enrolment
    • Previous treatment with any desensitisation procedure (with or without IVIg)
    • Concomitant malignancy or history of malignancy within 5 years prior to planned study entry (excluding successfully-treated non-metastatic basal/squamous cell carcinoma of the skin)
    • Evidence of significant local or systemic infection
    • HIV-positive, EBV-negative or suffering chronic viral hepatitis
    • Significant liver disease (persistently elevated AST and/or ALT levels > 2 x ULN)
    • Known primary haematological disorders.
    •Pazienti che abbiano ricevuto, o siano in attesa di ricevere trapianto di qualsiasi organo o tessuto, oltre al già programmato trapianto di rene
    •Intolleranza nota verso tacrolimus, micofenolato e corticosteroidi.
    °Prospettico dei loci HLA geneticamente identico al donatore.
    •Pra > 40% nei sei mesi precedenti l’arruolamento
    •Precedenti trattamenti con procedure di desensibilizzazione ( con o senza IVIg)
    •Neoplasie concomitanti o storia di neoplasia nei 5 anni precedenti l’arruolamento ( escludendo: i carcinomi della pelle non metastatici trattati con successo)
    •Infezioni locali o sistemiche documentate
    •Soggetti HIV positivi, EBV negativi o affetti da epatiti virali croniche
    •Significativi problemi epatici ( persistenza di valori elevati di AST o ALT > 2 x ULN)
    •Patologie ematologiche maligne o pre-maligne note
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the incidence of biopsy-confirmed acute rejection (BCAR).
    L’ end point primario consiste nella valutazione dell’ incidenza dei rigetti acuti, confermati con biopsia. (BCAR).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Incidences of BCAR occurring within 60 weeks following kidney transplantation will be evaluated in the final analysis.
    nell’analisi finale verrà valutata l’incidenza di BCAR avvenuti nelle 60 settimane successive al trapianto di rene
    E.5.2Secondary end point(s)
    Secondary endpoints include:

    • Time to first acute rejection episode
    • Severity of acute rejection episodes (based on response to treatment and histological scoring)
    • Total immunosuppressive burden at 60 weeks post-transplantation
    • Incidence of chronic graft dysfunction
    • Incidence of graft loss through rejection (acute/chronic)
    • Incidence of adverse drug reactions
    • Incidence of major infections
    • Incidence of neoplasia.
    •valutazione del tempo del primo episodio di rigetto acuto
    •valutazione del grado di severità dell’episodio di rigetto acuto ( sulla base della risposta al trattamento e ai punteggi istologici)
    •valutazione totale delle risposte immunosoppressive a 60 settimane post trapianto
    •valutazione dell’ incidenza di disfunzioni croniche di organo
    •valutazione di perdita dell’organo in seguito a reazione ( acuta/cronica)
    •valutazione dell’ incidenze di reazioni avverse ai farmaci
    •valutazione dell’incidenze di infezioni
    •valutazione dell’incidenza di neoplasie
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints occurring within 60 weeks following kidney transplantation will be evaluated in the final analysis.
    nell’ analisi finale verranno valutati gli end point secondari avvenuti entro 60 settimane dal trapianto di rene.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Establishment of immunological reference ranges in renal transplant patients treated with conventional immunosuppression.
    Istituzione di range immunologici di riferimento nel trapianto renale per pazienti trattati con terapia immunosoppressiva convenzionale
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    France
    Germany
    Italy
    United Kingdom
    United States
    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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    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 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) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 51
    F.4.2.2In the whole clinical trial 60
    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)
    Not different from the expected normal treatment of the condition. Details provided in the protocol - see page 40, protocol version 2.0, 10/12/2012.
    Nessuna differenza con il normale trattamento della patologia. Per ulteriori dettagli riferirsi alla pagina 40, protocollo versione 2.0, del 10/12/2012
    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 Decision2013-05-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-04
    P. End of Trial
    P.End of Trial StatusCompleted
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