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    The EU Clinical Trials Register currently displays   42567   clinical trials with a EudraCT protocol, of which   7008   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2021-002984-23
    Sponsor's Protocol Code Number:33-391ex20/21
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-07-19
    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 number2021-002984-23
    A.3Full title of the trial
    Retrospective quantification of anti-SARS-CoV-2 antibody response after mRNA COVID-19 vaccine in patients treated with peritoneal dialysis
    Retrospektive Quantifizierung anti-SARS-CoV2 Antikörper Anwort nach mRNA COVID-19 Impfstoff bei Perionealdialysepatient*innen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Determination of Covid-19 antibodies after vaccination with a mRNA vaccine in peritoneal dialysis patients
    Bestimmung von Covid-19 Antikörpern nach Impfung mit einem mRNA Impfstoff in PeritonealdialysepatientInnen
    A.4.1Sponsor's protocol code number33-391ex20/21
    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 SponsorMedical University of Graz
    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 supportMedical University of Graz
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical University of Graz
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressAuenbruggerplatz 27
    B.5.3.2Town/ cityGraz
    B.5.3.3Post code8036
    B.5.3.4CountryAustria
    B.5.6E-mailalexander.kirsch@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 Covid-19 Vaccine Moderna
    D.2.1.1.2Name of the Marketing Authorisation holderModerna Biotech Spain, S.L.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameCO­VID‑19 Vac­ci­ne Mo­der­na
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCOVID-19 mRNA Vaccine (nucleoside modified)
    D.3.9.1CAS number PR1
    D.3.9.2Current sponsor code005791
    D.3.9.3Other descriptive nameCOVID-19 mRNA vaccine Moderna (CX-024414)
    D.3.9.4EV Substance CodeSUB207171
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) Yes
    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
    Chronic peritoneal dialysis patients
    Chronische Peritonealdialyse PatientInnen
    E.1.1.1Medical condition in easily understood language
    Patients who suffer CKD and undergo a special form of dialysis, i.e. peritoneal dialysis
    Patienten die an einer chronischen Nierenerkrankung leiden und eine spezielle Form der Dialyse, nämlich der Peritonealdialyse untergehen
    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
    The present study aims to determine the serological immune response to the new SARS-CoV-2 vaccine (COVID-19 vaccine Moderna) in patients on chronic PD, as assessed by Roche Elecsys Anti-SARS-CoV2 S (Roche, )which detects antibodies against the SARS-CoV-2 virus (including neutralizing antibodies). Based on this study, conclusions can be drawn on whether the immune response is sufficient or alternative dosing regimens of vaccines might need further exploration.
    Diese Studie versucht die serologische Immunantwort auf die neue SARS-CoV-2 Impfung von Moderna in chronischen PD Patienten durch Assessment der Antikörper via des Roche Elecsys Anti-SARS-CoV-2 S festzustellen. Basierend auf dieser Studie können Rückschlüsse auf die suffiziente Immunantwort in diesen Patienten geben oder ob alternative Dosierregime untersucht werden müssen.
    E.2.2Secondary objectives of the trial
    Exploratory analysis: associations between baseline (immune) parameters, age strata (18- 59 and >=60 years of age), frailty score, HBV responder-status (non-responder: HBV titer <10 IE/L, low-responder: HBV titer 10-99 IE/L, responder: anti-HBs titer >100IE/L) with the serological response to the SARS-CoV-2 vaccination.
    Explorative Analyse:
    Assoziationen zwischen den Baseline Immunparamtern, Altersstratifizierung, Gebrechlichkeitsscore, HBV Immunantwortstatus
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    18 to 90 years of age
    End stage kidney disease patient undergoing peritoneal dialysis
    Patient was scheduled to receive an approved SARS-CoV2 vaccine as part of their routinely performed care
    Provided written informed consent for the “Bio-Bank”
    Alter zwischen 18 und 90 Jahren
    Dialysepflichtige Nierenerkrankung (PD)
    Patient hatte geplante Impfung mit Moderna Impfstoff
    Unterschriebener IC für die Biobank
    E.4Principal exclusion criteria
    No informed consent of the “Bio-Bank” was obtained
    Falls der IC nicht unterschrieben wurde
    E.5 End points
    E.5.1Primary end point(s)
    The anti-SARS-CoV2 level (estimated as geometric mean concentration, GMC) in patients on chronic dialysis (peritoneal dialysis) after the vaccination with COVID- 19 vaccine Moderna
    Anstieg der GMC (Geometrie mean concentration) in chronischen Dialysepatientinnen (PD) nach der Impfung mit dem COVID-19 Impfstoff von Moderna
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 weeks after first vaccination dose and 4 weeks after second vaccination dose
    4 Wochen nach erfolgter 1. und 4 Wochen nach erfolgter 2. Teilimpfung
    E.5.2Secondary end point(s)
    -
    -
    E.5.2.1Timepoint(s) of evaluation of this end point
    -
    -
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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 Yes
    E.8.1.7.1Other trial design description
    Retrospektive, nicht-invasive Studie
    Retrospective, non invasive study
    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.8.3 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-07-19. Yes
    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 state50
    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)
    none
    keine
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-08-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-15
    P. End of Trial
    P.End of Trial StatusOngoing
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