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    Summary
    EudraCT Number:2013-005417-13
    Sponsor's Protocol Code Number:13-HMedIdeS-02
    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:2014-03-03
    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 ConcernedSweden - MPA
    A.2EudraCT number2013-005417-13
    A.3Full title of the trial
    A PHASE II STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND EFFICACY OF INTRAVENOUS IDES AFTER ADMINISTRATION OF ASCENDING DOSES IN CHRONIC KIDNEY DISEASE PATIENTS
    Fas II för att utvärdera säkerhet, tolerabilitet och effekt av IdeS givet som intravenös behandling i stigande doser hos patienter med kronisk njursjukdom
    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 CHRONIC KIDNEY DISEASE PATIENTS
    EN STUDIE FÖR ATT UTVÄRDERA SÄKERHETEN OCH EFFEKTEN MED IDES I PATIENTER MED KRONISK NJURSJUKDOM
    A.4.1Sponsor's protocol code number13-HMedIdeS-02
    A.5.4Other Identifiers
    Name:Doc No 2014-007Number:2014-007
    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.1.3.4CountrySweden
    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.4.1Name of organisation providing supportHansa Medical AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    B.Sponsor: 2
    B.1.1Name of SponsorHansa Medical AB
    B.1.3.4CountrySweden
    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 supportHansa Medical AB
    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 AddressScheelvägen 22
    B.5.3.2Town/ cityLund
    B.5.3.3Post code22007
    B.5.3.4CountrySweden
    B.5.4Telephone number+46768581506
    B.5.6E-maillena.winstedt@hansamedical.com
    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
    Chronic kidney disease (CKD) stage 5 and on waiting list for renal transplantation
    Patienter med kronisk njursvikt som står på väntelistan för njurtransplantation
    E.1.1.1Medical condition in easily understood language
    Patients with chronic kidney failure who requires dialysis and are on the waiting list for kidney transplantation
    Patienter med kronisk njursvikt som är beroende av dialys och står på väntelistan för njurtransplantation
    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 find an IdeS dosing scheme which in the majority of the patients results in HLA antibody levels which are acceptable for transplantation. This will be measured as an MFI less than 1100 as measured in a single antigen bead (SAB) assay, within 24 hours from dosing
    Att hitta ett doseringsschema för IdeS som i merparten av patienterna resulterar i nivåer av HLA-antikroppar som är acceptabla för en transplantation. Detta kommer att definieras som ett MFI på 1100 eller mindre i en "single antigen bead (SAB) assay", inom 24 timmar efter dosering.
    E.2.2Secondary objectives of the trial
    To determine the following in CKD patients:
    1. Cytotoxic sera screen
    2. FACS crossmatch test against available donor cells
    3. The safety and tolerability of IdeS
    4. The pharmacokinetic (PK) profile of IdeS
    5. Pharmacodynamic (PD) profile of IdeS (cleavage of IgG)
    6. The immunogenicity profile of IdeS
    Analys av följande i patienter med kronisk njursvikt:
    1. Cytotoxisk serum screen
    2. FACS korstest mot tillgängligadonatorceller
    3. Säkerhet hos IdeS
    4. PK-profil
    5. PD-profil (klyvning av IgG)
    6. TImmunogenicitet (ADA)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age 18 years or above

    Diagnosed with CKD and in dialysis with identified antibodies against at least two HLA antigens of which at least one is 3000 MFI or more as measured by SAB assay on at least two occasions.
    18 år och äldre

    Diagnostiserad med kronisk njursvikt och i dialys med antikroppar mot minst två olika HLA-antigen varav minst ett är på över 3000 MFIuppmätt med SAB-analys vid minst två tillfällen.
    E.4Principal exclusion criteria
    1. Tested positive for IgE antibodies against IdeS
    2. Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and human immunodeficiency virus (HIV)
    3. Clinical signs of ongoing infectious disease.
    4. Patients who have had their spleen removed
    5.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
    6. Hypogammaglobulinemia defined as any values of P-total IgG less than 3 g/L
    7.Patients with an ongoing relapse in an autoimmune disease. However, patients with diabetes or IgA-nephritis will not be excluded from the study
    8.Patients who have undergone liver-, heart- or lungtransplantation
    9. Patients that have received cell transplantation or cell therapy within 5 years.
    10. Patients who have previously been treated with biological therapies based on antibodies within at least 5 T½ of the drug.
    1. Positiv test för anti-IdeS_antikroppar av IgE-typ
    2. Positiv test för hepatit B eller C eller HIV
    3.Symptom på pågående infektion
    4. Patienter med borttagen mjälte
    5. Annan allvarlig sjukdom, tex hjärtsvikt eller syrgasberoende COPD
    6. Hypogammaglobulinemi
    7. Patienter med relapserande autoimmun sjukdom. Patienter med diabetes eller igGA-nefrit kan dock inkluderas
    8.Patienter som genomgått lever- hjärt- eller lungtransplantation
    9. Patienter som genomgått celltransplantation eller cellterapi inom 5 år före inklusion
    10. Patienter som genomgått behandling med biologiska läkemedel baserade på antikroppar inom 5 halveringstider för det läkemedlet
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy defined as the IdeS dosing scheme resulting in HLA antibody levels which are acceptable for transplantation, measured as an MFI of less than 1100 as measured in an SAB assay, within 24 hours from dosing
    Effekt definierad som det dosschema som resulterar i nivåer av HLA-antikroppar som är acceptabla vid en njurtransplantation, uppmätt som MFI på 1100 eller mindre i en SAB-analys, inom 24 timmar från dosering.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1, 2, and 24 hours, 64 days
    1, 2, 24 timmar, 64 dagar
    E.5.2Secondary end point(s)
    Reduction of PRA levels in cytotoxic sera screen after IdeS treatment (efficacy)
    Result in FACS crossmatch test against available donor cells after IdeS treatment (efficacy)
    Safety parameters (Adverse events, clinical laboratory tests, vital signs and ECGs)
    Pharmacokinetic (PK) profile of IdeS
    Pharmacodynamic (PD) profile of IdeS (cleavage of IgG)
    • Immunogenicity of IdeS by measuring anti drug antibodies (ADA)
    Reduktion av PRA-nivåer i cytotoxisk screen efter behandling med IdeS
    Resultat i FACS-korstest mot tillgängliga donatorceller efter behandling med IdeS
    Säkerhetsparametrar (AEs, labtester, vital signs och EKG)
    PK-profil
    PD-profil
    Immunogenicitet (ADA)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy up to and including 24 hours after dosing
    PK up to and including 21 days
    PD up to and including 64 days
    ADA until day 365
    Effekt till och med 24 timmar efter dos
    PK till och med dag 21 efter dos
    PD till och med dag 54 efter dos
    ADA till och med dag 365 efter dos
    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 No
    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
    Immunogenicity
    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 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 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
    LVLS
    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 months
    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: 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 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 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)
    Continued dialysis
    Fortsatt dialys
    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 Decision2014-04-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-05-08
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