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    Summary
    EudraCT Number:2012-001923-11
    Sponsor's Protocol Code Number:Nef-202
    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:2012-09-24
    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 number2012-001923-11
    A.3Full title of the trial
    A Multicentre, Interventional treatment, Randomised, Double-Blind, Single Group Assignment Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon in primary IgA nephropathy patients at risk of developing end-stage renal disease
    Studio Interventistico Multicentrico, Randomizzato, in doppio Cieco, Singolo Gruppo di Assegnazione, Controllato vs. Placebo per valutare l'Efficacia e la Sicurezza di due differenti dosi di Nefecon in pazienti con nefropatie primaria da IgA a rischio di sviluppare una malattia renale all'ultimo stadio
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess if two different doses of Nefecon taken as a capsule are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal disease
    Studio per valutare se due differenti dosi di Nefecon assunto in capsule sono sicure ed efficaci in pazienti con nefropatia primaria da IgA a rischio di sviluppare una malattia renale all’ultimo stadio.
    A.3.2Name or abbreviated title of the trial where available
    NEFIGAN Trial
    NEFIGAN Trial
    A.4.1Sponsor's protocol code numberNef-202
    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 SponsorCROWN OY
    B.1.3.4CountryFinland
    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 supportPharmalink AB
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportCROWN OY
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharmalink AB
    B.5.2Functional name of contact pointProject Director (Alex Mecer)
    B.5.3 Address:
    B.5.3.1Street AddressEngelbrekts kyrogata 7B
    B.5.3.2Town/ cityStockolm
    B.5.3.3Post code11426
    B.5.3.4CountrySweden
    B.5.4Telephone number4684113005
    B.5.5Fax number46861113303
    B.5.6E-mailalex.mercer@pharmalink.se
    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 nameNefecon
    D.3.2Product code A07EA06
    D.3.4Pharmaceutical form Modified-release 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 INNBUDESONIDE
    D.3.9.1CAS number 51333-22-3
    D.3.9.4EV Substance CodeSUB05955MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 Yes
    D.3.11.13.1Other medicinal product typecorticosteroide topico
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboModified-release capsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Primary IgA nephropathy at risk of developing end stage renal disease
    Nefropatia primaria da IgA in pazienti a rischio di sviluppare una malattia renale all'ultimo stadio
    E.1.1.1Medical condition in easily understood language
    Primary IgA Nephropathy
    Nefropatia primaria da IgA
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10037034
    E.1.2Term Proteinuria present
    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 objective of the trial is to evaluate efficacy and safety of two different doses of Nefecon in the treatment of patients with primary IgA nephropathy (IgAN) at risk of developing end-stage renal disease, under rigorous blood pressure control with an angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin 2 receptor blocker (ARB).
    L'obiettivo dello studio è di valutare l'efficacia e la sicurezza di due diversi dosaggi di Nefecon nel trattamento di pazienti con nefropatia primaria da IgA (IgAN) a rischio di sviluppare un’insufficienza renale all’ultimo stadio, sotto rigoroso controllo della pressione arteriosa con inibitori dell’enzima di conversione dell'angiotensina (ACE-Inibitori) e/o di un bloccante del recettore dell'angiotensina 2 (ARB).
    E.2.2Secondary objectives of the trial
    To investigate whether patients on Nefecon achieve a larger mean reduction in urine protein creatinine ratio (UPCR) compared to patients on placebo at 9 months compared to baseline UPCR values
    Verificare se i pazienti in trattamento con Nefecon ottengono una maggiore riduzione media del rapporto proteine /creatinina urinario (UPCR) rispetto ai pazienti trattati con placebo a 9 mesi in confronton con i valori di UPCR al basale.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    OTHER SUBSTUDIES:
    Exploratory Analysis: Percentage change from baseline at 9 and 12 months on exploratory markers/biomarkers
    Urine and serum total IgA1/2, secretory IgA etc
    ALTRI SOTTOSTUDI:
    Analisi esplorative. Cambiamento percentuale dal Basale a 9 e 12 mesi su markers/biomarkers esplorativi
    IgA1/2 urinarie e seriche totali, IgA secretorie etc.
    E.3Principal inclusion criteria
    1.Female or male patients ≥18 years
    2.Biopsy-verified IgA nephropathy
    3.Urine protein creatinine ratio ≥0.5 g/g (56.5 mg/mmol)
    4.eGFR ≥50 mL/min per 1.73 m2 using CKD-EPI formula
    5.Willing to change antihypertensive medication regimen if applicable
    6.Willing and able to give informed consent
    1.Pazienti femmine o maschi di età ≥18 anni
    2.Nefropatia da IgA verificata con biopsia
    3.Rapporto urinario proteine/creatinina ≥0.5 g/g (56.5 mg/mmol)
    4.eGFR ≥50 mL/min per 1.73 m2 utilizzando l’equazione CKD-EPI
    5.Disponibile a cambiare il regime antiipertensivo, se applicabile
    6.Disponibile ed in grado di dare il consenso informato
    E.4Principal exclusion criteria
    1.Secondary forms of IgA nephropathy as defined by the treating physician (for example, Henoch–Schönlein purpura patients and those with associated alcoholic cirrhosis)
    2.Presence of crescent formation in ≥50% of glomeruli assessed on renal biopsy
    3.Kidney transplanted patients
    4.Severe gastrointestinal disorders (including peptic ulcer disease and inflammatory bowel disease) which may impair drug effect, or other conditions which could modify the effect of the trial drug as judged by the Investigator
    5.Consumption of an investigational drug within 30 days prior to enrolment
    6.Hyperlipidaemia defined as unacceptable levels of lipids according to the discretion of the Investigator
    7.Morbid obesity defined as a body mass index (BMI) >45 kg/m2
    8. Patients currently treated with systemic immunosuppressive or systemic corticosteroid drugs (excluding topical or nasal steroids) or have been previously treated for more than one week within the last 24 months.
    9. Patients currently treated chronically (daily dosing) with inhaled corticosteroid drugs or have previously been treated chronically for more than one month within the last 12 months
    10. Patients previously treated with immunosuppressive or systemic corticosteroids for the treatment of IgA nephropathy
    11.Patients unable to take oral medication or intolerant to budesonide or other corticosteroid preparations
    12.Patients with known allergy or intolerance to ACEI, ARB or to any component of the trial drug formulation
    13.Patients with acute or chronic infectious disease incl. hepatitis, HIV positive patients and patients with chronic urinary tract infections
    14.Severe liver disease according to the discretion of the Investigator
    15.Patients with Type 1 or 2 diabetes
    16.Patients with uncontrolled cardiovascular disease as judged by the Investigator
    17.Patients with current malignancy or history of malignancy during the last three years
    18. History or presence of psychological or psychiatric illness (including steroid induced psychosis) which may interfere with the patient´s ability to adhere to the protocol
    19. Patients with untreated osteoporosis
    20. Patients with glaucoma or cataract
    21. Alcohol or drug abuse (present)
    22. Patients unwilling to meet the requirements of the protocol
    23. Other medical or social reasons for exclusion at the discretion of the Investigator
    24. Life expectancy < 1 year
    25. For women only; pregnant or breast feeding or unwilling to use adequate contraception during the trial (only women of child bearing potential
    1.Forme secondarie di nefropatia da IgA come definite dai trattati medici (per esempio, pazienti affetti da Henoch–Schönlein purpura e pazienti con associata cirrosi alcolica)
    2.Presenza di crescenti formazioni nel ≥50% dei glomeruli valutati con la biopsia renale
    3.Pazienti con trapianto renale
    4.Gravi disordini gastrointestinali (includendo ulcera peptica e malattie infiammatorie intestinali) che potrebbero danneggiare l’effetto del farmaco od alterare le condizioni che possono modificare l’effetto del farmaco dello studio come giudicato dallo sperimentatore
    5.Consumo di un farmaco sperimentale nei 30 giorni prima dell’arruolamento
    6.Iperlipidemia definita come livelli inaccettabili di lipidi in accordo alla discrezione dello sperimentatore
    7.Obesità patologica definita con indice di massa corporea (BMI) &gt;45 kg/m2
    8.Pazienti correntemente trattati con immunosoppressori sistemici o con farmaci corticosteroidi sistemici (escludendo gli steroidi per via topica o nasale) o che sono stati trattati in precedenza per più di una settimana negli ultimi 24 mesi.
    9.Pazienti trattati correntemente e cronicamente (dosaggio giornaliero)con farmaci corticosteroidi per via inalatoria or o che sono stati trattati cronicamente in precedenza per più di un mese negli ultimi 12 mesi.
    10.Pazienti precedentemente trattati con immunosoppressivi o corticosteroidi sistemici per il trattamento della nefropatia da IgA.
    11.Pazienti non in grado di assumere un farmaco per via orale od intolleranti alla budesonide od ad altre preparazioni corticosteroidee
    12.Pazienti con conosciuta allergia od intolleranza agli ACE-inibitori, ARB o a qualsiasi componente presente nella formulazione del farmaco dello studio
    13.Pazienti con malattie infettive acute o croniche incluse epatiti, pazienti con HIV positive e pazienti con infezioni croniche del tratto urinario.
    14.Malattie epatiche gravi in accordo al giudizio dello sperimentatore
    15.Pazienti con diabete di Tipo 1 o 2
    16.Pazienti con malattie cardiovascolari non controllate come giudicate dallo sperimentatore
    17.Pazienti con corrente tumore maligno o storia tumorale maligna durante gli ultimi 3 anni
    18.Storia o presenza di malattia psicologica o psichiatrica (includendo psicosi indotta da steroide) che possa interferire sulla capacità del paziente ad aderire al protocollo
    19.Pazienti con osteoporosi non trattata
    20.Pazienti con glaucoma o cataratta
    21.Alcool od abuso di droga (presente)
    22.Pazienti riluttanti a rispettare le richieste del protocollo
    23.Altre ragioni mediche o sociali per l’esclusione a discrezione dello Sperimentatore
    24.Spettanza di vita &lt; 1 anno
    25.Per le solo donne: pazienti in gravidanza od in allattamento o riluttanti ad utilizzare un adeguato metodo di contraccezione durante lo studio ( solo per donne in età fertile)
    E.5 End points
    E.5.1Primary end point(s)
    To investigate whether patients on Nefecon achieve a larger mean reduction in urine protein creatinine ratio (UPCR) compared to patients on placebo during a 9 months trial
    Verificare se i pazienti in trattamento con Nefecon ottengono una maggiore riduzione media del rapporto proteine /creatinina urinario (UPCR) rispetto ai pazienti trattati con placebo durante i 9 mesi dello studio
    E.5.1.1Timepoint(s) of evaluation of this end point
    Nine months of treatment
    Nove Mesi di trattamento
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoint(s)
    -remission defined as Complete Remission (<0.3g/g UPCR), Partial Remission (≥0.3g/g to <1.0g/g + 50% reduction in UPCR from baseline), Treatment Failure (≥1.0g/g OR <50% reduction in UPCR from baseline) at Month 9
    -percentage change in urine albumin creatinine ratio (UACR) and urine albumin from baseline at Month 9
    -achieving reduction by ≥50% in UPCR at Month 9 compared to baseline
    -percentage change in serum creatinine, chronic kidney disease epidemiology collaboration equation (CKD-EPI) estimated glomerular filtration rate (eGFR), modification of diet in renal disease study equation (MDRD) eGFR and creatinine clearance from baseline at 9 months

    Tertiary Efficacy Endpoint(s)
    -achieving defined reductions (≥30%, ≥35%, ≥40%, ≥45%, ≥50%, ≥55%, ≥60%) of UPCR, UACR and urine albumin at Month 9 compared to baseline
    -achieving defined reductions (≥30%, ≥35%, ≥40%, ≥45%, ≥50%, ≥55%, ≥60%) of UPCR, UACR and urine albumin from baseline at Months 1, 3, 5, 7, 10.5 and 12
    - percentage change in UPCR, UACR and urine albumin from baseline at 1, 3, 5, 7, 10.5 and 12 months
    - percentage change in serum creatinine, CKD-EPI eGFR, MDRD eGFR and creatinine clearance from baseline at 1, 3, 5, 7, 10.5, and 12 months
    -percentage change in Cystatin C-basedeGFR from baseline at Months 9 and 12
    -microhematuria at Months 9 and 12
    La remissione sarà definita come Completa Remissione (<0.3g/g UPCR), Parziale Remissione (≥0.3g/g a <1.0g/g + 50% di riduzione dell’ UPCR rispetto al basale), Fallimento del Trattamento (≥1.0g/g o riduzione <50% in UPCR rispetto al basale al Mese 9.
    -Cambiamento percentuale nel rapporto urinario albumina creatinina (UACR) ed albumina urinaria dal basale al Mese 9.
    -Raggiungimento di una riduzione ≥50% in UPCR al Mese 9 rispetto al basale
    -Cambiamento percentuale nella creatinina serica, epidemiologia dell’insufficienza renale cronica valutata con l’equazione (CKD-EPI) che stima la velocità di filtrazione glomerulare (eGFR) e con l’equazione sulla Modificazione della Dieta nella Malattia Renale (MDRD) che stima sempre l’eGFR e la clearance della creatinina dal basale a 9 Mesi.

    Obbiettivi Terziari di Efficacia
    -Raggiungimento di riduzioni definite (≥30%, ≥35%, ≥40%, ≥45%, ≥50%, ≥55%, ≥60%) di UPCR, UACR ed albumina urinaria al Mese 9 in confronto al basale.
    -Raggiungimento di riduzioni definite (≥30%, ≥35%, ≥40%, ≥45%, ≥50%, ≥55%, ≥60%) di UPCR, UACR ed albumina urinaria dal basale ai Mesi 1, 3, 5, 7, 10.5 e 12
    -Cambiamento percentuale in UPCR, UACR e albumina urinaria dal basale a 1, 3, 5, 7, 10.5 e 12 mesi.
    -Cambiamento percentuale nella creatinine serica, CKD-EPI eGFR, MDRD eGFR e nella clearance della creatinina dal basale a 1, 3, 5, 7, 10.5 e 12 mesi
    -Cambiamento percentuale in Cistatina C-basata sull’ eGFR dal basale ai Mesi 9 e 12
    -microematuria ai Mesi 9 e 12
    E.5.2.1Timepoint(s) of evaluation of this end point
    Nine months of treatment
    Nove mesi di trattamento
    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 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 Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    - Stesso farmaco ad altro dosaggio
    - same IMP used at different dosage
    E.8.2.4Number of treatment arms in the trial3
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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 months30
    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 months30
    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.1.1Number of subjects for this age range: 0
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 200
    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)
    Normal treatment in accordance with the guide lines of the general practice
    Trattamento previsto dalle linee guida della pratica clinica
    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 Decision2012-09-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-09-09
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