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    Summary
    EudraCT Number:2019-002068-29
    Sponsor's Protocol Code Number:ANCA_CGM
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2019-09-12
    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 ConcernedAustria - BASG
    A.2EudraCT number2019-002068-29
    A.3Full title of the trial
    Influence of once vs twice daily corticosteroid administration on glycemia assessed by continuous glucose monitoring in patients with ANCA vasculitis
    Auswirkung einer einmal vs zweimal täglichen Kortikosteroidgabe auf die Blutzuckerwerte bei Patienten mit ANCA-Vaskulitis gemessen mittels kontinuierlicher Blutzuckermessung
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Influence of split corticosteroid dose on glucose metabolism in patients with autoimmune kidney disease
    Auswirkung einer aufgeteilten Kortikosteroid-Dosis auf den Glukosestoffwechsel bei Patienten mit Autoimmunerkrankung der Nieren
    A.3.2Name or abbreviated title of the trial where available
    ANCA_CGM
    ANCA_CGM
    A.4.1Sponsor's protocol code numberANCA_CGM
    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 SponsorMedizinische Universität Graz, Universitätsklinik für Innere Medizin, Klinische Abteilung für Nephrologie
    B.1.3.4CountryAustria
    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 supportMedizinische Universität Graz
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedizinische Universität Graz
    B.5.2Functional name of contact pointDiabetes Studienambulanz
    B.5.3 Address:
    B.5.3.1Street AddressAuenbruggerplatz 15
    B.5.3.2Town/ cityGraz
    B.5.3.3Post code8036
    B.5.3.4CountryAustria
    B.5.4Telephone number+43316385 78062
    B.5.5Fax number+43316385 14332
    B.5.6E-mailtina.poettler@medunigraz.at
    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 Aprednislon
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Gesellschaft mbH
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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.3.8INN - Proposed INN Prednisolone
    D.3.9.3Other descriptive namePREDNISOLONE
    D.3.9.4EV Substance CodeSUB10018MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    ANCA vasculitis
    ANCA-assoziierte Vaskulitis
    E.1.1.1Medical condition in easily understood language
    Autoimmune swelling or inflammation of blood vessels
    Autoimmun bedingte Schwellung oder Entzündung der Blutgefässe
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    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
    To investigate the efficacy of splitting the total daily corticosteroid dose in two equal corticosteroid doses in patients with ANCA vasculitis
    Evaluierung der Wirksamkeit des Aufteilens der täglichen Kortikosteroid-Dosis auf eine zweimal tägliche Gabe in Patienten mit ANCA-assoziierten Vaskulitis

    E.2.2Secondary objectives of the trial
    Safety
    To investigate the safety of splitting the total daily corticosteroid dose in two equal corticosteroid doses in patients with ANCA vasculitis

    Efficacy
    To investigate further efficacy parameters of dividing the total daily corticosteroid dose in two equal corticosteroid doses in patients with ANCA vasculitis

    Sicherheit
    Evaluierung der Sicherheit des Aufteilens der täglichen Kortikosteroid-Dosis auf eine zweimal tägliche Gabe in Patienten mit ANCA-assoziierten Vaskulitis

    Wirksamkeit
    Evaluierung der weiteren Wirksamkeitparameter des Aufteilens der täglichen Kortikosteroid-Dosis auf eine zweimal tägliche Gabe in Patienten mit ANCA-assoziierten Vaskulitis
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Informed consent obtained after being advised of the nature of the study
    •Male or female aged 18-80 years (both inclusive)
    •Newly diagnosed ANCA vasculitis with involvement of the kidney requiring high-dose corticosteroid therapy
    •Einwilligung nach Aufklärung über die Art der Studie
    •Männer oder Frauen im Alter von 18-80 Jahren (beides inklusive)
    •Neu diagnostizierte ANCA-assoziierte Vaskulitis die hoch dosierte Kortikosteroidtherapie erfordert
    E.4Principal exclusion criteria
    •Pre-existing diabetes mellitus
    •Continuous parenteral nutrition
    •Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods during the study
    •History of bleeding disorder
    •Current participation in another clinical study
    •Significant acute or chronic illness that may interfere with subject safety or integrity of results as judged by the investigator
    •Significant history of alcoholism or drug abuse or a positive result in urine drug/alcohol screen
    •Any mental condition rendering the patient incapable of giving his/her consent
    •Known or suspected allergy to insulins glargine, aspart, glulisine or lispro
    •Vorbestehender Diabetes mellitus
    •Kontinuierliche parenterale Ernährung
    •Schwangere oder stillende Frauen, Frauen die schwanger werden möchten bzw. während der Studie keine adäquate Schwangerschaftsverhütung betreiben
    •Diagnostizierte Bluterkrankung
    •Teilnahme an einer anderen Studie, welche die Ergebnisse der Studie beeinflussen könnte
    •Jede Krankheit oder jeder Zustand, die nach Meinung des Prüfers oder behandelnden Arztes die Studie oder die Sicherheit des Patienten beeinträchtigen könnten
    •Alkohol oder Drogenmissbrauch oder positiver Alkohol/Drogen Urintest
    •Jeder geistige Zustand, der den Patienten unfähig macht, seine Zustimmung zu geben
    •Bekannte oder erwartete Allergie auf Insulin glargin, aspart, glulisin oder lispro

    E.5 End points
    E.5.1Primary end point(s)
    Mean percentage of time in target (70-140mg/dl) assessed by blinded continuous glucose monitoring (CGM)
    Mittlerer Prozentsatz der Glukosemessung im Zielbereich (70-140mg/dl) gemessen mittels verblindeter kontinuierlicher Glukosemessung (CGM)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Following study completion
    Nach Studienende
    E.5.2Secondary end point(s)
    •Number and percentage of glucose measurements (CGM, BG) in the following ranges: 0-<40mg/dl (BG only), 40-<70mg/dl, 70-<100mg/dl, 100-140mg/dl, >140-180mg/dl, 180-<300mg/dl, ≥ 300mg/dl
    •Time of glucose measurements (CGM, BG) in the following ranges: 0-<40mg/dl (BG only), 40-<70mg/dl, 70-<100mg/dl, 100-140mg/dl, >140-180mg/dl, 180-<300mg/dl, ≥ 300mg/dl
    •Mean daily blood glucose as calculated by premeal and bedtime glucose values: overall and per treatment day
    •Mean pre-breakfast BG, mean pre-lunch BG, mean pre-dinner BG and mean bedtime BG
    •Pre-enrolment HbA1c
    •Mean pre-enrolment BG
    •Number of additionally required BG measurements
    •Number of insulin injections per day
    •Daily insulin dose (basal, bolus, total)
    •Relevant concomitant medication (corticosteroids, parenteral nutrition, antibiotics, oral hypoglycemic agents)
    •Relevant medication at time of hospital discharge (insulin therapy – type and dose, oral hypoglycemic agents)
    •Post-discharge diabetes therapy (insulin therapy – type and total daily dose, oral hypoglycemic agents)
    •HbA1c
    •Adverse events
    •Corticosteroid dose
    •Body weight and BMI
    •Hypoglycemic events
    •Birmingham Vasculitis Score (BVAS)
    •Serum-Creatinine and glomerular filtration rate evaluated by the CKD-EPI formula
    •Albuminuria (Urinary Albumin/Creatinine Ratio)
    •Erythrocytes and casts in the urinary sediment
    •Quality of life assessment by SF-36 questionnaire
    •Anzahl und Prozent der Glukosewerte (CGM, BG) in den folgenden Bereichen: 0-<40mg/dl (nur Blutglukose), 40-<70mg/dl, 70-<100mg/dl, 100 140mg/dl, >140-180mg/dl, 180-<300mg/dl, ≥ 300mg/dl
    •Zeit der Glukosewerte (CGM, BG) in den folgenden Bereichen: 0-<40mg/dl (nur Blutglukose), 40-<70mg/dl, 70-<100mg/dl, 100-140mg/dl, >140 180mg/dl, 180-<300mg/dl, ≥ 300mg/dl
    •Mittlere tägliche Blutglukose basierend auf den präprandialen und bedtime Glukosewerten: gesamt und pro Behandlungstag
    •Mittlere Blutglukose vor den jeweiligen Zeitpunkten: vor dem Frühstück, vor dem Mittagessen, vor dem Abendessen, bedtime
    •HbA1c
    •Mittlere Blutglukose vor Studienstart während des stationären Aufenthaltes
    •Anzahl der zusätzlichen Blutglukosewerte
    •Anzahl der Insulininjektionen pro Tag
    •Insulin-Tagesdosis (Basis, Bolus, Gesamt)
    •Relevante Begleitmedikation während des stationären Aufenthaltes (Kortikosteroide,
    parenterale Ernährung, orale Antidiabetika)
    •Relevante Diabetesmedikation bei Entlassung aus der stationären Versorgung
    (Insulintherapie – Art und Dosis, orale Antidiabetika)
    •Diabetestherapie bei Entlassung aus der stationären Versorgung
    •HbA1c bei Entlassung aus der stationären Versorgung
    •Unerwünschte Zwischenfälle bei Entlassung aus der stationären Versorgung
    •Kortikosteroid-Dosis bei Entlassung aus der stationären Versorgung
    •Körpergewicht und BMI bei Entlassung aus der stationären Versorgung
    •Hypoglykämie bei Entlassung aus der stationären Versorgung
    •Birmingham Vasculitis Score (BVAS) bei Entlassung aus der stationären Versorgung
    •Kreatinin und GFR bestimmt mit der CKD-EPI Formel bei Erstdiagnose und bei Entlassung
    •Protein- und Albuminurie bei Erstdiagnose und bei Entlassung
    •Erythrozyten und Harnsediment bei Erstdiagnose und bei Entlassung
    •Lebensqualität gemessen am SF-36 Fragebogen
    E.5.2.1Timepoint(s) of evaluation of this end point
    Following study completion
    Nach Studienende
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Intraindividueller Vergeleich
    Within-subject comparison
    E.8.2.4Number of treatment arms in the trial2
    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 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
    Letzte Visite des/der letzten TeilnehmerIn
    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 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: 8
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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)
    According to local treatment standards for ANCA vasculitis
    Nach lokalen Behandlungsrichtlinien für ANCA-assoziierte Vaskulitis
    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 Decision2019-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-08-27
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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