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    Summary
    EudraCT Number:2021-002640-70
    Sponsor's Protocol Code Number:20-HMedIdeS-19
    National Competent Authority:Slovenia - JAZMP
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-01-31
    Trial 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 ConcernedSlovenia - JAZMP
    A.2EudraCT number2021-002640-70
    A.3Full title of the trial
    A controlled, open-label post-authorisation efficacy and safety study in imlifidase desensitised kidney transplant patients with positive crossmatch against a deceased donor prior to imlifidase treatment, including non-comparative registry and concurrent reference cohorts
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study in highly sensitised kidney transplant patients with a high degree of antibodies against the donor's kidney to see the efficacy and safety of imlifidase to temporarily remove the antibodies and enable the transplantation.
    A.4.1Sponsor's protocol code number20-HMedIdeS-19
    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 Biopharma 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 Biopharma AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHansa Biopharma AB
    B.5.2Functional name of contact pointClinical contact information
    B.5.3 Address:
    B.5.3.1Street AddressP.O. Box 785
    B.5.3.2Town/ cityLund
    B.5.3.3Post codeSE-220 07
    B.5.3.4CountrySweden
    B.5.6E-mailclinicalstudyinfo@hansabiopharma.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 Yes
    D.2.1.1.1Trade name Idefirix
    D.2.1.1.2Name of the Marketing Authorisation holderHansa Biopharma AB
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/16/1826
    D.3 Description of the IMP
    D.3.1Product nameImlifidase
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNImlifidase
    D.3.9.1CAS number 1947415-68-0
    D.3.9.3Other descriptive nameIMLIFIDASE
    D.3.9.4EV Substance CodeSUB191871
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number11
    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
    E.1.1.1Medical condition in easily understood language
    end stage chronic kidney disease (CKD), are highly sensitized and placed on the kidney transplant list awaiting a kidney transplant.
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10023439
    E.1.2Term Kidney transplant rejection
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the 1-year graft failure-free survival in highly sensitised kidney transplant patients, pre-treated with imlifidase to turn a positive crossmatch against a deceased donor negative
    E.2.2Secondary objectives of the trial
    Secondary objectives relating to imlifidase treatment group
    •renal function up to 1 year after transplantation
    •patient survival 1 year after transplantation
    •graft survival 1 year after transplantation
    •crossmatch conversion within 24 hours of imlifidase treatment
    •HLA/DSA antibody levels up to 1 year after transplantation
    •pharmacokinetic (PK) profile of imlifidase
    •pharmacodynamic (PD) profile of imlifidase
    •immunogenicity profile of imlifidase (anti-drug antibodies [ADAs])
    •delayed graft function (DGF)
    •for further secondary objectives relating to imlifidase treatment group see protocol
    Secondary Objectives relating to the non-comparative concurrent reference cohort (see protocol)
    Secondary Objectives relating to the randomly selected non-comparative historical reference cohort retrieved from the CTS registry (see protocol)
    Exploratory objective relating to the imlifidase treatment group and the concurrent reference cohort (see protocol)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria for all patients
    1. Male or female patient aged 18-75 years
    2. ABO-compatible deceased donor aged 10-70 years

    Inclusion Criteria for imlifidase patients
    1. End-stage renal disease (ESRD) active on the renal transplant waiting list of a kidney allocation system at the time of screening
    2. High sensitisation with the highest unmet medical need unlikely to be transplanted under the available kidney allocation system including prioritisation programmes for highly sensitised patients (see table below for recommended reference thresholds. Note: highest unmet medical need is per investigator's discretion)
    3. Known DSA against an available deceased donor
    4. Positive crossmatch test determined by Complement-Dependent Cytotoxicity crossmatch (CDCXM) and/or Flow Cytometry Crossmatch (FCXM) against an available deceased donor. If physical crossmatch tests are not practically possible due to lack of time, patients may be included on a Virtual Crossmatch (vXM) predictive of a positive crossmatch test.
    5. Signed Informed Consent obtained before any trial-related procedures
    6. Willingness and ability to comply with the protocol
    Recommended reference thresholds for highest unmet medical need depending on sensitisation within different European allocation system (see protocol)

    Inclusion Criteria for patients in the non-comparative concurrent reference cohort
    1. Active on the renal transplant waiting list at a participating trial site at the time of screening
    2. An acceptable kidney transplant from a deceased donor
    3. Signed Informed Consent obtained before any trial related procedures
    4. Willingness and ability to comply with the protocol

    Inclusion Criteria for patients in the non-comparative historical reference cohort
    1. End-stage renal disease with a kidney transplant from a deceased donor
    2. Being transplanted in Europe after 01-Jan-2010 and included in the CTS registry
    3. PRA ≥ 50% (CDC T or B cell PRA, cPRA, or virtual PRA [vPRA])
    4. Maintenance immunosuppression (intention to treat) with calcineurin inhibitor, mycophenolate mofetil (MMF) and corticosteroids in combination
    E.4Principal exclusion criteria
    Exclusion Criteria for imlifidase patients and for patients in the non-comparative concurrent reference cohort
    1. Use of investigational agents within 5 terminal elimination half-lives prior to the transplantation
    2. Malignancy within 5 years prior to transplantation
    3. Positive serology for human immunodeficiency virus (HIV)
    4. Clinically relevant active infection(s) (including hepatitis B [HBV], hepatitis C [HCV], cytomegalovirus [CMV], Epstein Barr Virus [EBV], tuberculosis) as judged by the investigator
    5. Contemporaneous participation in medical device studies
    6. Known mental incapacity or language barriers precluding adequate understanding of the Informed Consent information and the trial activities
    7. Inability by the judgement of the investigator to participate in the trial for any other reason
    Exclusion Criteria for imlifidase patients
    1. Previous treatment with imlifidase
    2. Previous high dose IVIg treatment (2 g/kg) within 28 days prior to imlifidase treatment
    3. Suspicion of Covid-19 infection or positive SARS-CoV-2 test
    4. Breast feeding or pregnancy
    5. Hypersensitivity to the active substance (imlifidase) or to any of the excipients (see section 5.1)
    6. Ongoing serious infections (including HBV, HCV, CMV, EBV, tuberculosis)
    7. Present, or history of, thrombotic thrombocytopenic purpura (TTP), or known familial history of TTP
    8. Severe other condition requiring treatment and close monitoring e.g. cardiac failure ≥ grade 4 (New York Heart Association), unstable coronary disease or oxygen dependent respiratory disease
    9. Female of childbearing potential, not willing to use effective contraception during the 3 weeks following treatment with imlifidase. In the context of this trial, an effective method is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly.
    10. Any other reason that, in the view of the investigator, precludes transplantation

    Exclusion Criteria for patients in the non-comparative historical reference cohort
    1. Patients treated with mTOR (mammalian target of rapamycin) inhibitors
    2. Patients treated with belatacept
    E.5 End points
    E.5.1Primary end point(s)
    1-year graft failure-free survival rate in patients who have been kidney transplanted after imlifidase treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    One year after transplantation
    E.5.2Secondary end point(s)
    Secondary endpoints relating to imlifidase treatment
    - Renal function at several time points between 24 hours and 2 weeks and at 1, 3 and 6 months and 1 year after transplantation as assessed by estimated glomerular filtration rate (eGFR) and serum/plasma creatinine levels
    - Patient survival at 1 year after transplantation
    - Graft survival at 1 year after transplantation
    - Proportion of patients with conversion of a positive crossmatch test to negative within 24 hours after imlifidase treatment
    - HLA/DSA antibody levels at several time points between pre-dose imlifidase and 2 weeks, and at 1, 3 and 6 months and 1 year after imlifidase treatment
    - Imlifidase PK up to 14 days after imlifidase treatment
    - Imlifidase PD up to 9 days after imlifidase treatment
    - ADAs up to 1 year after imlifidase treatment
    - Frequency of DGF
    - Proportion of patients with biopsy- and serology (DSA)-confirmed AMRs over 1 year
    - Proportion of patients with biopsy confirmed CMRs over 1 year.
    - Safety over 1 year as measured by reported SAEs
    - Safety assessed as proportion of patients with infusion-related reactions within 48 hours of imlifidase infusion
    - Safety assessed as proportion of patients with severe or serious infections within 30 days after transplantation
    - Change in patient-reported life participation, as measured by the PROMIS Social Health domain “Ability to participate in social roles & activities, PROMIS-SF-8a”, from baseline to 1 year after transplantation

    Secondary endpoints relating to the non-comparative concurrent reference cohort
    - Graft failure-free survival at 1 year after transplantation
    - Renal function at 1, 3 and 6 months and 1 year after transplantation as assessed by eGFR and serum/plasma creatinine levels
    - Patient survival at 1 year after transplantation
    - Graft survival at 1 year after transplantation
    - Frequency of DGF
    - Proportion of patients with biopsy- and serology (DSA)-confirmed AMRs over 1 year
    - Proportion of patients with biopsy confirmed CMRs over 1 year
    - Safety over 1 year as measured by reported SAEs
    - Safety assessed as proportion of patients with severe or serious infections within 30 days after transplantation
    - Change in patient reported life participation, as measured by the PROMIS Social Health domain “Ability to participate in social roles & activities, PROMIS-SF-8a”, from baseline to 1 year after transplantation

    Secondary endpoints relating to the randomly selected non-comparative historical reference cohort retrieved from the CTS registry
    - Graft survival at 1 year after transplantation
    - Renal function at 3 and 6 months, and 1 year as measured by serum/plasma creatinine category (<130 μmol/L, 130-259 μmol/L, 260-400 μmol/L and >400 μmol/L) (eGFR only available in selected patients)
    - Patient survival at 1 year after transplantation
    - Proportion of patients with rejection episodes (AMRs and CMRs) during the first post-transplant year in patients with a functioning graft at the end of the first post-transplant year
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Renal function at several time points between 24 hours and 2 weeks and at 1, 3 and 6 months and 1 year after transplantation as assessed by eGFR and serum/plasma creatinine levels
    - Patient survival at 1 year after transplantation
    - Graft survival at 1 year after transplantation
    - Proportion of patients with conversion of a positive crossmatch test to negative within 24 hours after imlifidase treatment
    - HLA/DSA antibody levels at several time points between pre-dose imlifidase and 2 weeks and at 1, 3 and 6 months and 1 year after imlifidase treatment
    - Imlifidase PK up to 14 days after imlifidase treatment
    - Imlifidase PD up to 9 days after imlifidase treatment
    - ADAs up to 1 year after imlifidase treatment
    - Frequency of DGF
    For more timepoints see protocol
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 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
    non-comparative concurrent reference cohort; non-comparative historical reference cohort
    E.8.2.4Number of treatment arms in the trial2
    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 EEA20
    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
    United Kingdom
    Austria
    Belgium
    Czechia
    France
    Germany
    Italy
    Netherlands
    Slovenia
    Spain
    Sweden
    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 months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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: 125
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 138
    F.4.2.2In the whole clinical trial 150
    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
    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 Decision2023-10-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-10-26
    P. End of Trial
    P.End of Trial StatusOngoing
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