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    The EU Clinical Trials Register currently displays   42336   clinical trials with a EudraCT protocol, of which   6971   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2012-004004-36
    Sponsor's Protocol Code Number:ZP-PDProtec-102
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-12-03
    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 ConcernedAustria - BASG
    A.2EudraCT number2012-004004-36
    A.3Full title of the trial
    Pilot Study to define the Feasibility of ex-vivo LPS stimulated Cytokine release for Testing Efficacy of the Addition of Alanyl-Glutamine-Dipeptide to Dialysis Solutions in Peritoneal Dialysis (PD)
    Eine Pilotstudie zur Erhebung der Machbarkeit der ex-vivo LPS stimulierten Zytokin Freisetzung als Test für Wirksamkeit des Zusatzes von Alanyl-Glutamin-Dipeptide zur Dialyse-Lösung bei Peritoneal-Dialyse
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pilot Study to define the Feasibility of Cytokine Release for Testing Efficacy of the Additon of Alanyl-Glutamine-Dipeptide to Dialysis Solutions in Peritoneal Dialysis
    Eine Pilotstude zur Erhebung der Machbarkeit der Zytokin Freisetzung als Test für die Wirksamkeit des Zusatzes von Alanyl-Glutamin-Dipeptid zur Dialyse-Lösung bei Peritoneal-Dialyse.
    A.4.1Sponsor's protocol code numberZP-PDProtec-102
    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 SponsorMed. Univ. Wien, UK für Kinder und Jugendheilkunde
    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 supportMed. University of Vienna
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMed. University of Vienna
    B.5.2Functional name of contact pointChristoph Aufricht, Representatitve
    B.5.3 Address:
    B.5.3.1Street AddressWähringer Gürtel 18-20
    B.5.3.2Town/ cityWien
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.4Telephone number004301404002288
    B.5.6E-mailchristoph.aufricht@meduniwien.ac.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 Dipeptiven - concentrate for solution for injection/infusion
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi Austria Graz
    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 Concentrate for solution for injection/infusion
    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 39537-23-0
    D.3.9.2Current sponsor codeMedical University of Vienna
    D.3.9.3Other descriptive nameN(2)-L-ALANYL-L-GLUTAMINE
    D.3.9.4EV Substance CodeSUB34011
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number200
    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
    Peritoneal dialysis is a process of removing metabolic waste products
    and excess water from the patient's body,
    replacing the function of the diseased kidneys.
    Currently, despite the clear benefits of PD, long-term treatment is
    limited due to an inherent lack of
    biocompatibility of current PD fluids. The combination of standard PDFs
    and alanyl-glutamine-dipeptide is
    designed as a cytoprotective PDF that allows a significantly longer
    duration of the treatment
    E.1.1.1Medical condition in easily understood language
    The combination of standard peritoneal dialysis fluid and alanylglutamine-
    dipeptide is designed as a cytoprotective PDF that allows a
    significantly longer duration of the treatment.
    E.1.1.2Therapeutic area Body processes [G] - Cell Physiological Phenomena [G04]
    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 objective of this study is to evaluate the feasibility and safety of the
    addition of alanyl-glutamine-dipeptide to
    dialysis solutions in "Peritoneal Dialysis" (PD) patients.
    Zu welchem Zeitpunkt des gesammelten Dialysats kann der Outcome Parameter „ex-vivo LPS stimulierten Zytokin Freisetzung aus peritonealen Leukozyten“ in über 80% der Patienten aussagekräftige Daten bringen? (Machbarkeit)
    E.2.2Secondary objectives of the trial
    Efficacy on cellular level of 2 different dosis of alanyl glutamine
    Vergleich mit vs. ohne Zugabe von Dipeptiven® in zwei Dosierungen (8
    mmol und 16 mmol) zu Physioneal® hinsichtlich:
    LPS stimulierte Zytokin Freisetzung, Cell count, Zytospin, FACS , Cell
    culture, Protein/omics, RNA/mRNA, Gln, Phagozytose, CA125, AOPPs,
    GSH/GSSG ratio und Verträglichkeit .
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    An Open Label, Randomized, Two-Period Crossover Study to Evaluate the
    Safety and Efficacy of the Addition of Alanyl-Glutamine-Dipeptide to
    Dialy-sis Solution in Peritoneal Dialysis (PD)
    objective: Primary Objective
    To evaluate treatment safety and efficacy of Alanyl-Glutamine-Dipeptide
    as addition to dialysis solution in PD.
    Eine offene, randomisierte, zwei Phasen, cross-over Studie zur
    Evaluierung der Sicherheit und Wirksamkeit der zusätzlichen Gabe von
    Alanyl-Glutamin-Dipeptid zur Dialyse-Lösung bei Peritoneal-Dialyse.
    Ziel: Die Anwendung von Alanyl-Glutamin-Dipeptid in Peritoneal-Dialyse-
    Lösungen , Wirkung auf Expression der Hitze-Schock-Proteine
    E.3Principal inclusion criteria
    signed informed consent
    female, male aged > 19
    chronic kindney failure; stable for 2 month on PD with Physioneal®
    no peritonitis within 2 month of study start
    negative pregnancy test for females with childbearing potential
    Unterzeichnete Patienteninformation/Einverständniserklärung vor Beginn der studienspezifischen Untersuchungen
    Frauen und Männer > 19
    chronisches Nierenversagen, 2 Monate stabile PD mit Physioneal®
    keine Peritionitis in den letzten zwei Monaten
    keine schwerwiegenden Begleiterkrankungen
    Negativer Schwangerschaftstest und ausreichende Verhütung bei Frauen im gebärfähigen Alter
    E.4Principal exclusion criteria
    maligne disease treated with chemotherapy or radiation
    limited efficacy of PD due to anatomical abnormalities or severe intraabdominal
    adhesion
    clinically significant increased markers of inflammation
    body weight < 50 kg
    Patient under Immunsuppressiva
    Bekannte Überempfindlichkeit auf das Prüfpräparat
    Behandlung mit einem anderen Prüfpräparat während eines Monats vor Studienbeginn
    Maligne Erkrankung mit laufender Chemo- oder Strahlentherapie
    Schwangerschaft und Stillperiode
    Begrenzte Effektivität der PD auf Grund anatomischer Anomalien oder schwere intraabdomineller Verwachsungen
    CRP>5mg/dl
    Körpergewicht < 50 kg
    laufende Immunsuppressive Therapie
    E.5 End points
    E.5.1Primary end point(s)
    cytokine release for different timepoints
    ex-vivo LPS (Lipopolysaccharid) stimulierte Zytokin Freisetzung aus
    peritonealen Leukozyten zu verschiedenen Zeitpunkten jeder
    Behandlungssequenz (nach 6-12h Dialysat Verweildauer(ZP0), nach 60
    und 240 Minuten)

    Sicherheit
    E.5.1.1Timepoint(s) of evaluation of this end point
    within 111 days
    innerhalb von 111 Tagen
    E.5.2Secondary end point(s)
    peritoneale cellpopulation at three different timepoints - characterised through
    Cell Count
    Zytospin
    FACS
    Protein/omics
    RNA/ mRNA
    Gln, Phagozytosis
    Vergleich mit vs. ohne Zugabe von Dipeptiven® in zwei Dosierungen (8mmol und 16mmol) zu Physioneal® hinisichtlich:
    LPS stimulierte Zytokin Freisetzung, Cell count, Zytospin, FACS, Cell culture, Protein/omics, RNA/mRNA, Gln, Phagozytosis, CA 125, AOPPs, GSH/GSSG ratio
    E.5.2.1Timepoint(s) of evaluation of this end point
    within 111 days
    innerhalb 111 Tage
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    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
    PDF without Alanyl-Glutamine-Dipeptide
    E.8.2.4Number of treatment arms in the trial6
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    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: 4
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 No
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-01-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-10
    P. End of Trial
    P.End of Trial StatusCompleted
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