Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-01-04 @ 3:34 AM
Study NCT ID:
NCT05937750
Status:
RECRUITING
Last Update Posted:
2025-02-19
First Post:
2023-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Long-term Follow-up Trial of Patients Previously Treated With Imlifidase Prior to Kidney Transplantation and a Non-comparative Transplanted Patient Group
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C039557', 'term': 'phenyl-2-aminoethyl sulfide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a long-term follow-up trial following an open-label, non-randomized trial in highly sensitized adult kidney transplant patients with positive crossmatch (XM) against an available deceased donor.\n\nThe rational for the main trial, 20-HMedIdeS-19 (PAES), being non-randomized is that no other effective or approved desensitization protocol exists in deceased-donor kidney transplantation that would provide a suitable control. A non-comparative concurrent reference cohort from participating sites was included to address differences in-site practice and experience.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2030-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-17', 'studyFirstSubmitDate': '2023-06-13', 'studyFirstSubmitQcDate': '2023-06-30', 'lastUpdatePostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Graft failure-free survival (%) up to 5 years after imlifidase enabled transplantation (imlifidase cohort only)', 'timeFrame': '5-years after transplantation', 'description': 'Graft failure is defined as permanent return to dialysis for at least 6 weeks, re-transplantation, or nephrectomy. Patients not undergoing transplantation will be censored at time zero (i.e. at entry into the PAES trial). Transplanted patients not having an event (graft failure or death) will be censored at the last known date being alive and having a functioning graft.\n\nThe 5-year graft failure-free survival rates will be estimated using the Kaplan-Meier estimator. Time from enrolment to the first of death or graft failure will be used as time variable.'}], 'secondaryOutcomes': [{'measure': 'Graft failure-free survival (%) up to 5 years after transplantation (non-comparative concurrent reference cohort only)', 'timeFrame': '5-years after transplantation', 'description': 'Graft failure is defined as permanent return to dialysis for at least 6 weeks, re-transplantation, or nephrectomy. Patients not undergoing transplantation will be censored at time zero (i.e. at entry into the PAES trial). Transplanted patients not having an event (graft failure or death) will be censored at the last known date being alive and having a functioning graft.\n\nThe 5-year graft failure-free survival rates will be estimated using the Kaplan-Meier estimator. Time from enrolment to the first of death or graft failure will be used as time variable.'}, {'measure': 'Graft failure-free survival (%) up to 2 and 3 years after transplantation', 'timeFrame': '2 and 3-years after transplantation', 'description': 'Graft failure is defined as permanent return to dialysis for at least 6 weeks, re-transplantation, or nephrectomy. Patients not undergoing transplantation will be censored at time zero (i.e. at entry into the PAES trial). Transplanted patients not having an event (graft failure or death) will be censored at the last known date being alive and having a functioning graft.\n\nThe 2 and 3-year graft failure-free survival rates will be estimated using the Kaplan-Meier estimator. Time from enrolment to the first of death or graft failure will be used as time variable.'}, {'measure': 'Renal function as evaluated by estimated Glomerular Filtration Rate (eGFR) and serum/plasma creatinine levels', 'timeFrame': '2, 3, and 5-years after transplantation', 'description': 'Kidney function assessed by eGFR and serum/plasma creatinine will be summarised over 5 years for the imlifidase group and the reference cohort.\n\neGFR is a measure of kidney function. The serum/plasma creatinine levels will be analysed and eGFR will be calculated according to the modification of diet in renal disease (MDRD) equation.\n\nReduced kidney function is characterised by a decreased eGFR value. For patients in the imlifidase group who are not successfully transplanted, or for any enrolled patients without a functioning graft, their eGFR values will be set to 0 mL/min.'}, {'measure': 'Patient survival (%) after transplantation', 'timeFrame': '2, 3, and 5-years after transplantation', 'description': 'Patient survival up to 2, 3 and 5 years, respectively, will be assessed for the imlifidase group and the reference cohort.\n\nThe 2, 3, and 5-year patient survival rates will be extracted from Kaplan-Meier curves.'}, {'measure': 'Graft survival (%) after transplantation', 'timeFrame': '2, 3, and 5-years after transplantation', 'description': 'Graft survival up to 2, 3 and 5 years, respectively, will be assessed for the imlifidase group and the reference cohort.\n\nGraft survival will be presented with Kaplan-Meier curves. Graft failure is defined as permanent return to dialysis for at least 6 weeks, re-transplantation, or nephrectomy. Patients who die will be censored at time of death.'}, {'measure': 'Human Leukocyte Antigen (HLA)/Donor Specific Antibodies (DSA) levels (imlifidase cohort only)', 'timeFrame': '2, 3, and 5-years after transplantation', 'description': 'HLA antibodies will be analysed using an IgG single antigen solid-phase immunoassay for class I and class II (SAB-HLA).\n\nDonor specific antibodies (DSAs) are identified by using the human leukocyte antigen (HLA) profile data from the donor and the recipient to identify HLA-mismatches.\n\nThe mean fluorescence intensity (MFI) will be summarized for all DSAs with an MFI of ≥1000 at any time during the trial (or the PAES trial).'}, {'measure': 'Anti-drug antibody (ADA) levels (imlifidase cohort only)', 'timeFrame': '2, 3, and 5-years after transplantation', 'description': 'Determination of anti-imlifidase IgG (ADA) concentration in serum will be performed centrally using a customised ImmunoCAP to evaluate imlifidase long-term immunogenicity.'}, {'measure': 'Proportion of patients (%) with biopsy- and serology (DSA)-confirmed Antibody Mediated Rejections (AMRs)', 'timeFrame': '2, 3, and 5-years after transplantation', 'description': 'For-cause biopsies will be obtained to confirm diagnosis for suspected AMRs in both treatment arms.\n\nThe biopsies will be analysed locally and centrally and evaluated according to Banff criteria version 2017 or later.'}, {'measure': 'Proportion of patients (%) with biopsy confirmed Cell-Mediated Rejections (CMRs)', 'timeFrame': '2, 3, and 5-years after transplantation', 'description': 'For-cause biopsies will be obtained to confirm diagnosis for suspected CMRs in both treatment arms.\n\nThe biopsies will be analysed locally and centrally and evaluated according to Banff criteria version 2017 or later.'}, {'measure': 'Treatment of graft rejections', 'timeFrame': '2, 3, and 5-years after transplantation', 'description': 'The number of graft rejection episodes treated with dialysis will be recorded'}, {'measure': 'Treatment of graft rejection', 'timeFrame': '2, 3, and 5-years after transplantation', 'description': 'The number of graft rejection episodes treated with plasmapheresis will be recorded'}, {'measure': 'Treatment of graft rejection', 'timeFrame': '2, 3, and 5-years after transplantation', 'description': 'The number of graft rejection episodes treated with medication will be recorded'}, {'measure': 'Adverse events (AEs)/serious adverse events (SAEs) suspected to be related to imlifidase treatment (imlifidase cohort only)', 'timeFrame': '2, 3, and 5-years after transplantation', 'description': 'AEs/SAEs suspected to be related to imlifidase treatment in the PAES trial will be recorded from the time of signed informed consent for participation in the trial until the last trial visit.'}, {'measure': 'Use of immunosuppressive medication', 'timeFrame': '2, 3, and 5-years after transplantation', 'description': "The patient's use of immunosuppressive medications will be recorded for both cohorts from the time of signed informed consent for participation in the trial until the last trial visit."}, {'measure': 'Comorbidities', 'timeFrame': '2, 3, and 5-years after transplantation', 'description': "Information about comorbidities that are medically relevant and registered in the patient' medical record will be collected. Medically relevant comorbidities are infections, malignancy, diabetes mellitus and cardiovascular events."}, {'measure': 'Change in patient reported life participation', 'timeFrame': '2, 3, and 5-years after transplantation', 'description': 'The Patient-Reported Outcomes Measurement Information System (PROMIS) Social Health domain "Ability to participate in social roles \\& activities, PROMIS-SF-8a" will be used as a measure of the patients\' health related quality of life.\n\nThe questionnaire includes 8 questions about a persons ability to participate in different social activities and there are 5 different answers to choose from for each question: Never/Rarely/Sometimes/Usually/Always'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Renal transplantation', 'Kidney transplantation'], 'conditions': ['Long Term Efficacy and Safety']}, 'descriptionModule': {'briefSummary': 'A prospective, post-authorisation long-term follow-up trial of patients previously treated with imlifidase prior to kidney transplantation, including a non-comparative concurrent reference cohort.', 'detailedDescription': "This is a long-term follow-up trial to the post-authorisation efficacy and safety (PAES) trial (trial 20-HMedIdeS-19). The trial will include patients who participated in the PAES trial and were transplanted with a new kidney after treatment with imlifidase (trial drug) or standard of care medication. Imlifidase is a medicine used to prevent the body from rejecting a newly transplanted kidney and is used before transplantation in adults who have antibodies against the donor kidney and are considered 'highly sensitised' based on a positive crossmatch test.\n\nThe purpose of this follow-up trial is to fulfil requirements from the European Medicines Agency (EMA) to continue to evaluate efficacy (kidney function) and safety (side effects) over time, for the patients who were transplanted with a new kidney in the PAES trial. The patients will be followed for up to 5 years after transplantation in the PAES trial to collect valuable long-term data."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '76 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed Informed Consent obtained before any trial-related procedures\n* Willingness and ability to comply with the protocol\n* Previously transplanted in the clinical trial 20-HmedIdeS-19 (PAES)\n\nExclusion Criteria:\n\n* Inability by the judgment of the investigator to participate in the trial for other reasons'}, 'identificationModule': {'nctId': 'NCT05937750', 'acronym': 'PAES-LTFU', 'briefTitle': 'A Long-term Follow-up Trial of Patients Previously Treated With Imlifidase Prior to Kidney Transplantation and a Non-comparative Transplanted Patient Group', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hansa Biopharma AB'}, 'officialTitle': 'A Prospective, Post-authorisation Long-term Follow-up Trial of Patients Previously Treated With Imlifidase Prior to Kidney Transplantation, Including a Non-comparative Concurrent Reference Cohort', 'orgStudyIdInfo': {'id': '20-HMedIdeS-20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Imlifidase', 'description': 'Imlifidase administered in the 20-HMedIdeS-19 (PAES) study', 'interventionNames': ['Drug: Imlifidase administered in the 20-HMedIdeS-19 (PAES) study']}, {'type': 'EXPERIMENTAL', 'label': 'Non-Comparative Concurrent Reference Cohort', 'description': 'Best available treatment administered in the 20-HMedIdeS-19 (PAES) study', 'interventionNames': ['Other: Best available treatment administered in the 20-HMedIdeS-19 (PAES) study']}], 'interventions': [{'name': 'Imlifidase administered in the 20-HMedIdeS-19 (PAES) study', 'type': 'DRUG', 'otherNames': ['IdeS', 'HMED-IdeS', 'Idefirix'], 'description': "Imlifidase is an immunoglobulin G (IgG)-degrading enzyme of Streptococcus pyogenes that is highly selective towards IgG. The cleavage of IgG generates one F(ab')2- and one homodimeric Fc-fragment and efficiently neutralizes Fc-mediated activities of IgG.", 'armGroupLabels': ['Imlifidase']}, {'name': 'Best available treatment administered in the 20-HMedIdeS-19 (PAES) study', 'type': 'OTHER', 'description': "Normal transplantation routine Transplantation and pre- and post-transplantation therapies in accordance with the clinic's normal transplantation routine.", 'armGroupLabels': ['Non-Comparative Concurrent Reference Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Rainer Oberbauer, MD', 'role': 'CONTACT', 'email': 'rainer.oberbauer@meduniwien.ac.at'}, {'name': 'Rainer Oberbauer, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medizinische Universitaet Wien', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '140-21', 'city': 'Prague', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Ondrej Viklický, MD', 'role': 'CONTACT', 'email': 'ondrej.viklicky@ikem.cz'}, {'name': 'Ondrej Viklický, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nephrology Clinic Vídeňská 1958/9', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '35128', 'city': 'Padua', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Paolo Rigotti, MD', 'role': 'CONTACT', 'email': 'paolo.rigotti@unipd.it'}, {'name': 'Paolo Rigotti, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliera di Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '08035', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'O Bestard, MD', 'role': 'CONTACT', 'email': 'oriol.bestard@vallhebron.cat'}, {'name': 'O Bestrad', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario del Vall d´Hebron', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'F Diekmann, MD', 'role': 'CONTACT', 'email': 'fdiekman@clinic.cat'}, {'name': 'F Diekmann, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Unidad de Trasplante Renal', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28041', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Amado Andres, MD', 'role': 'CONTACT', 'email': 'amado.andres@salud.madrid.org'}, {'name': 'Amado Andres', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario 12 De Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '751 85', 'city': 'Uppsala', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Tomas Lorant, MD', 'role': 'CONTACT', 'email': 'tomas.lorant@surgsci.uu.se'}, {'name': 'Tomas Lorant, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Uppsala University Hospital', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'centralContacts': [{'name': 'Central Contact', 'role': 'CONTACT', 'email': 'clinicalstudyinfo@hansabiopharma.com', 'phone': '+46 46 16 56 70'}], 'overallOfficials': [{'name': 'Clinical Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hansa Biopharma AB'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hansa Biopharma AB', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}