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    Summary
    EudraCT Number:2014-000712-34
    Sponsor's Protocol Code Number:13-HMedIdeS-03
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-06-02
    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 ConcernedSweden - MPA
    A.2EudraCT number2014-000712-34
    A.3Full title of the trial
    A PHASE II STUDY TO EVALUATE THE SAFETY, TOLERABILITY, EFFICACY AND PHARMACOKINETICS OF INTRAVENOUS ASCENDING DOSES OF IDES IN KIDNEY TRANSPLANTATION
    En Fas II-studie för att utvärdera säkerhet, tolerabilitet, effekt och farmakokinetik hos intravenösa stigande doser av IdeS vid njurtransplantation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A STUDY TO EVALUATE THE SAFETY AND EFFICACY OF IDES IN KIDNEY TRANSPLANTATION
    Studie för att utvärdera IdeS säkerhet och effekt vid njurtransplantation
    A.4.1Sponsor's protocol code number13-HMedIdeS-03
    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 SponsorHansa Medical AB
    B.1.3.4Country
    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 supportVinnova
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHansa Medical AB
    B.5.2Functional name of contact pointHansa Medical AB
    B.5.3 Address:
    B.5.3.1Street AddressScheelevägen 22
    B.5.3.2Town/ cityLund
    B.5.3.3Post code22007
    B.5.3.4CountrySweden
    B.5.4Telephone number+46768581506
    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 nameHMEDIdeS
    D.3.2Product code HMEDIdeS
    D.3.4Pharmaceutical form Concentrate and solvent for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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
    Removal of anti-HLA antibodies in patients planned to undergo kidney transplantation
    Elimination av HLA-antikroppar hos patienter som ska genomgå njurtransplantation
    E.1.1.1Medical condition in easily understood language
    Treatment of patients planned to undergo kidney transplantation
    Behandling av patienter som ska njurtransplanteras
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To study the safety and tolerability of IdeS min renal transplantation
    Att studera säkerhet och tolerabilitet hos IdeS vid njurtransplantation
    E.2.2Secondary objectives of the trial
    1. To find an IdeS dose which in the majority of the patients results in HLA antibody levels acceptable for transplantation.
    2. Cytotoxic sera screen
    3. FACS crossmatch test
    4. The pharmacokinetic
    5. Pharmacodynamic
    6. Immunogenicity
    7. Kidney function
    1. Att hitta en IdeS-dos som resulterar i HLA-nivåer acceptabla för njurtransplanation i majoriteten av patienterna
    2. Cytotoxisk serumscreen
    3. FACS korstest
    4. farmakokinetik
    5. Farmakodynamik
    6. Immunogenicitet
    7. Njurfunktion
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age 18 years or above
    2. Patients diagnosed with CKD and in dialysis with one of the following conditions will be included:
    • Preformed anti-HLA antibodies (non-DSA, DSA or both), negative T-CDC CXM and at least one antibody MFI > 3000
    1. minst 18 år
    2. Diagnostiserad med kronisk njursjukdom och i dialys och med något av följande :
    • HLA -antikroppar (icke-DSA, DSA eller båda), negativ T-CDC CXM och:
    med minst en antikropp MFI>3000
    E.4Principal exclusion criteria
    Clinical signs of ongoing infectious disease. This includes P-CRP >10.

    Severe other conditions requiring treatment and close monitoring, e.g. cardiac failure > NYHA (New York Heart Association) grade 3, unstable coronary disease or oxygen dependent COPD
    Kliniska tecken på pågående infektion

    Andra allvarliga sjukdomar som kräver behandling eller nogrann uppföljning
    E.5 End points
    E.5.1Primary end point(s)
    Safety parameters (Adverse events, clinical laboratory tests, vital signs and ECGs)
    Säkerhet (Adverse events, laboratorietester, vital signs och ECG)
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    6 månader
    E.5.2Secondary end point(s)
    1. To find an IdeS dose which in the majority of the patients results in HLA antibody levels acceptable for transplantation.
    2. Cytotoxic sera screen
    3. FACS crossmatch test
    4. The pharmacokinetic
    5. Pharmacodynamic
    6. Immunogenicity
    7. Kidney function
    8. Reduction i PRA levels
    1. Att hitta en IdeS-dos som resulterar i HLA-nivåer acceptabla för njurtransplanation i majoriteten av patienterna
    2. Cytotoxisk serumscreen
    3. FACS korstest
    4. farmakokinetik
    5. Farmakodynamik
    6. Immunogenicitet
    7. Njurfunktion
    8. Reduktion i PRA-nivåer
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 h
    24 h
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenecity
    Immunogenicitet
    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 No
    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 No
    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 No
    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 concerned2
    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 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
    LSLV
    LSLV
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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: 12
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    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)
    Follow up at Uppsala university hospital and Karolinska university hospital according to standard procedures for this patient group.
    Uppföljning på Uppsala universitetssjukhus enligt rutiner för denna patientgrupp
    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 Decision2014-07-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-10-13
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