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    Summary
    EudraCT Number:2016-002064-13
    Sponsor's Protocol Code Number:15-HMedIdeS-06
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-02-12
    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 ConcernedFrance - ANSM
    A.2EudraCT number2016-002064-13
    A.3Full title of the trial
    A Phase II Study to Evaluate the Efficacy of IdeS (IgG endopeptidase) to Desensitize Transplant Patients with a Positive Crossmatch Test
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase II Study to Evaluate the Efficacy of IdeS to reduce antibodies in Transplant Patients with a Positive Crossmatch Test
    A.4.1Sponsor's protocol code number15-HMedIdeS-06
    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 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 pointGunilla Eckerwall
    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 number0046733420 405
    B.5.6E-mailgunilla.eckerwall@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 nameHMED-IdeS
    D.3.2Product code HMED-IdeS
    D.3.4Pharmaceutical form 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 Yes
    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 with donor specific antibodies (ASA)
    E.1.1.1Medical condition in easily understood language
    Chronic Kidney Disease with antibodies to donated organ
    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 asses the IdeS efficacy in creating a negative crossmatch test
    E.2.2Secondary objectives of the trial
    To determine DSA levels at multiple times
    To determine time to creating a negative CDC crossmatch test
    To determine time to creating a negative FACS crossmatch test
    To evaluate safety parameters
    To monitor kidney function after IdeS treatment
    To establish the pharmacokinetic (PK) profile of IdeS
    To establish the pharmacodynamic (PD) profile of IdeS
    To establish the immunogenicity profile (ADA) of IdeS
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male or female age 18-70 years at the time of screening
    Patients on the kidney transplant waitlist who have previously undergone desensitization unsuccessfully or in whom effective desensitization will be highly unlikely. The breadth and strength of sensitization will predict an extremely low likelihood of successful desensitization or kidney paired donation. For Sweden eligible patients must fulfil the criteria to be listed on the Scandia Transplant Acceptable Mismatch Program (STAMP) - on transplantation waiting list more than 1 year - HLA antibody status with PRA more than or equal to 80% based on CDC and/or solid phase assay - HLA status confirmed by two consecutive samples over a period of more than 3 months - proven reactivity against HLA class I or II andtigens or both - last tested sample drawn less than 3 months before acceptande
    Patients with a medically acceptable live donor are eligible if they fulfil the criteria to be listed on the Scandinavian Transplant Kidney Exchange Program (STEP) - recipient with donor specific antibodies - positive crossmatch between recipient and live donor.
    Patients with a live or deceased donor with a positive crossmatch test.
    Patient must be able to understand and sign the informed consent
    E.4Principal exclusion criteria
    Previous treatment with IdeS
    Previous high dose IVIg treatment (2 g/kg BW) within 28 days prior to IdeS treatment
    Lactating or pregnant females, women of child-bearing age who are not willing or able to practice FDA-approved forms of contraception. European centers will follow guidelines issued by EMAs Clinical Trial Facilitation Group (CTFG) 2014-09-15 as follows:
    a - combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: i/ oral - ii/intravaginal - iii/ transdermal
    b. - progesterone-only hormonal contraception associated with inhibition of ovulation: i/oral - ii/ injectable
    c. - vasectomized partner provided that partner is the sole sexual partner of the trial participant and that the vasecomized partner has received medical assessment of the surgical success.
    HIV-positive patients
    Patients with HBV infection or HCV infection
    Patients with active tuberculosis
    A significantly abnormal general serum screening lab result according to the investigator’s judgement.
    Severe other conditions requiring treatment and close monitoring, e.g. cardiac failure, unstable coronary disease or oxygen dependent COPD
    Patients with active CMV or EBV infection
    Patients with a history of clinically significant thrombotic episodes, and patients with active peripheral vascular disease
    Allergy/sensivity to any of the ingredients of IMP
    Patients who have a live donor and test positive for ImmunoCAP anti-IdeS IgE
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy defined as IdeS ability to create a negative crossmatch test within 24 hours after IdeS dosing
    E.5.1.1Timepoint(s) of evaluation of this end point
    Within 24 hours after IdeS dosing
    E.5.2Secondary end point(s)
    DSA levels at pre-dose and 2, 6, 24 and 48 hours and days 7, 14, 21, 28, 64, 90, 120 and 180 post IdeS treatment
    Time to creating a negative CDC crossmatch test
    Time to creating a negative FACS crossmatch test
    Safety parameters (adverse events, clinical laboratory tests, vital signs and ECGs)
    Kidney function after IdeS treatment assessed by, filtration (eGFR), creatinine and proteinuria up to 180 days post treatment
    Pharmacokinetic (PK) profile of IdeS up to day 14
    Pharmacodynamic (PD) profile of IdeS (cleavage and recovery of IgG) up to day 180 post IdeS
    Immunogenicity profile of IdeS by measuring anti-drug antibodies (ADA)
    E.5.2.1Timepoint(s) of evaluation of this end point
    DSA levels at pre-dose and 2, 6, 24 and 48 hours and days 7, 14, 21, 28, 64, 90, 120 and 180 post IdeS treatment
    Safety parameters at 2, 6, 24 and 48 hours and days 3, 7, 9, 14, 21, 28, 64, 90, 120 and 180 post IdeS treatment
    Kidney function at 24 and 48 hours and days 3, 7, 9, 14, 21, 28, 64, 90, 120 and 180 post IdeS treatment

    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
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA2
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Sweden
    United States
    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
    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 months3
    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 months5
    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: 14
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 7
    F.4.2.2In the whole clinical trial 20
    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 Necker hospital according to clinical praxis for kidney transplanted patients.
    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 Decision2017-01-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-07-03
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