Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43854   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2013-004956-39
    Sponsor's Protocol Code Number:SMART-DSA
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-05-06
    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 ConcernedGermany - BfArM
    A.2EudraCT number2013-004956-39
    A.3Full title of the trial
    Study to evaluate the impact of donor-specific HLA-antibodies on graft function and survival after renal transplantation - Long term follow up of the SMART study population
    Studie zur Einschätzung der Bedeutung von donor-spezifischen HLA-Antikörpern auf die Funktion und das Überleben des Transplantats nach Nierentransplantation - Langzeit Beobachtung von Teilnehmern der SMART Studie -
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate the impact of donor-specific antibodies on graft function and survival after renal transplantation - Long term follow up of the SMART study population
    Studie zur Einschätzung der Bedeutung von donor-spezifischen Antikörpern auf die Funktion und das Überleben des Transplantats nach Nierentransplantation - Langzeit Beobachtung von Teilnehmern der SMART Studie -
    A.4.1Sponsor's protocol code numberSMART-DSA
    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 SponsorKlinikum der Universität München
    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 supportPfizer Pharma GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKlinik für Allgemeine, Viszeral-, Transplantations-, Gefäß- und Thoraxchirurgie
    B.5.2Functional name of contact pointKCS Chirurgie
    B.5.3 Address:
    B.5.3.1Street AddressMarchioninistrasse 15
    B.5.3.2Town/ cityMünchen
    B.5.3.3Post code81377
    B.5.3.4CountryGermany
    B.5.4Telephone number0049(0)8970950
    B.5.6E-mailkcs@med.uni-muenchen.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 Rapamune
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameSirolimus
    D.3.4Pharmaceutical form Coated 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 INNSIROLIMUS
    D.3.9.1CAS number 53123-88-9
    D.3.9.4EV Substance CodeSUB10537MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.5 to 2
    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) 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: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Sandimmun
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameCiclosporin
    D.3.4Pharmaceutical form Capsule, soft
    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 INNCICLOSPORIN
    D.3.9.1CAS number 59865-13-3
    D.3.9.4EV Substance CodeSUB06250MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 100
    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) 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
    Renal Transplantation
    Nierentransplantation
    E.1.1.1Medical condition in easily understood language
    Renal transplantation
    Nierentransplantation
    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 18.1
    E.1.2Level LLT
    E.1.2Classification code 10023438
    E.1.2Term Kidney transplant
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Long term treatment effects of a sirolimus based treatment compared to a ciclosporin based regimen shall be studied by comparing the randomized treatment groups of the former SMART-Study. The main question is whether different immunosuppressive regimens correlate with detection of donor specific antibodies in the follow up.
    Durch den Vergleich der beiden in der SMART-Studie randomisierten Patientengruppen nach Studienende sollen Langzeit-Effekte der Sirolimus-basierten Therapie im Vergleich zu einer Cyclosporin-haltigen Therapie untersucht werden. Insbesondere soll untersucht werden, inwieweit durch unterschiedliche, immunsuppressiv wirkende Medikamente (Sirolimus vs. Cyclosporin A) das Vorliegen von donor-spezifischen HLA-Antikörpern beeinflusst wird.
    E.2.2Secondary objectives of the trial
    Are there differences in the long term follow up between different immunosuppressive regimens after renal transplantation and is there a relationship between immunusuppressive therapy and detection of donor-specific antibodies on the one and the long term transplant function/survival on the other hand.
    Wie wird der Langzeitverlauf nach Nierentransplantation durch die unterschiedlichen immunsuppressiv wirkenden Medikamente (Sirolimus vs. Cyclosporin A) verändert? Möglicherweise lässt sich so ein Zusammenhang herstellen zwischen Konzentration / Vorliegen von donor-spezifischen Antikörpern und verabreichter Immunsuppression einerseits und dem klinischen Langzeitverlauf bzw. der Transplantatfunktion andererseits. Weiterhin sollen Erkenntnisse zum Auftreten neuer Begleiterkrankungen und von schwerwiegenden unerwünschten Ereignissen (SAE) gewonnen werden.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients who have participated in the former SMART Trial will be included, if the give written informed consent to participate in the present study.
    The main inclusion criteria into the SMART study were:
    - Male end female patients between 18 and 65 years of age who were scheduled to receive renal transplantation
    - first and second renal transplantation
    - PRA (panel reactive antibody titers) <= 30%
    Aufgenommen in die Studie werden alle Patienten, die in die SMART-Studie randomisiert worden waren und die ihr schriftliches Einverständnis erteilen, an dieser Studie teilzunehmen
    Die Haupt-Einschlus Kriterien in die SMART-Studie waren:
    - Männliche und weibliche Patienten im Alter zwischen 18 und 65 Jahren mit Indikation zur Nierentransplantation
    - Erste oder zweite Nierentransplantation
    - PRA <= 30%
    E.4Principal exclusion criteria
    Missing written informed consent
    Patient do not come to the follow up visit within 3 months
    Fehlendes schriftliches Einverständnis des Patienten
    Patienten, die nicht innerhalb von 3 Monaten zu einem Follow Up Besuch erscheinen
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint is the incidence of de novo donor-specific antibodies at the time of the current visit.
    Das primäre Zielkriterium ist die Inzidenz von de novo donorspezifischen Antikörpern bis zum Zeitpunkt der aktuellen Kontrolluntersuchung
    E.5.1.1Timepoint(s) of evaluation of this end point
    Median about years after transplantation
    Median ca 6 Jahre nach Transplantation
    E.5.2Secondary end point(s)
    Time to first detection of donor-specific antibodies
    Correlation between development of donor-specific antibodies and acute rejections
    Status (de novo) and class and concentration of donor-specific antibodies
    Patient and graft survival
    biopsy proven rejections
    first biopsy proven antibody mediated rejection
    renal function (creatinine, calculated glomerular filtration rate)
    switch of immunosuppressive regimen due to treatment failure
    Frequency of new treatment related concomitant diseases
    Serious adverse events
    Zeit bis zum ersten Nachweis von DSA nach Transplantation,
    Zusammenhang zwischen akuten Abstoßungen und der Entwicklung von DSA,
    DSA nach Status (ob de novo) und Klasse, sowie Konzentration
    Patienten- und Transplantatüberleben,
    biopsiegesicherte Abstoßungen,
    erste biopsiegesicherte Antikörper-vermittelte Abstoßung
    Nierenfunktion (Kreatinin, berechnete GFR/Clearance),
    Therapieversagen (Umstellung der Therapie),
    Auftreten von Tumoren,
    Häufigkeit neu aufgetretener unerwünschte Begleiterkrankungen,
    Schwerwiegende unerwünschte Ereignisse
    E.5.2.1Timepoint(s) of evaluation of this end point
    Median about 6 jears after transplantation
    Median ca. 6 Jahre nach Transplantation
    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 No
    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 Yes
    E.8.1.7.1Other trial design description
    retrospektive Kohortenstudie mit akueller Untersuchung von donor-spezifischen Antikörpern
    retrospective cohort study with current assessment of donor specific antibodies
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 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
    The single planned follow up visit of the last patient included into this follow up study is defined as end of study.
    Der einzige geplante Besuch des letzten in die Beobachtungsstudie eingeschlossenen Patienten wird als Studienende definiert.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years9
    E.8.9.1In the Member State concerned months6
    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: 100
    F.1.3Elderly (>=65 years) No
    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 state100
    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)
    Forther treatment according to local practice.
    Weiterbehandlung nach Maßgabe des behandelnden Arztes.
    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 Decision2014-05-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-05-18
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Tue Apr 23 10:56:45 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA