Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-24 @ 5:24 PM
Study NCT ID:
NCT04711850
Status:
TERMINATED
Last Update Posted:
2025-05-28
First Post:
2021-01-13
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
An Long-term Follow-up Trial of Kidney Tx Patients Treated With Imlifidase or PE After an AMR
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C442815', 'term': 'Mac-1-like protein, Streptococcus'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@hansabiopharma.com', 'phone': '+4646165670', 'title': 'Vice President Research and Development', 'organization': 'Hansa Biopharma AB'}, 'certainAgreement': {'otherDetails': 'At the end of the study, one or more manuscripts for joint publication may be prepared in collaboration between the investigator(s) offered authorship and Hansa Biopharma.\n\nAny confidential information relating to imlifidase or the study, including any data and results from the study will be the exclusive property of Hansa Biopharma AB. The investigators and any other persons involved in the trial will protect the confidentiality of the proprietary information belonging to Hansa Biopharma AB', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Early termination leading to small number of subjects analyzed.'}}, 'adverseEventsModule': {'timeFrame': 'From inclusion in the study until end of study (Year 3).', 'description': 'Only AEs related to trial procedure or related to IMP administered in feeder trial were to be collected.', 'eventGroups': [{'id': 'EG000', 'title': 'Imlifidase Treatment in Feeder Study 16-HMedIdeS-12', 'description': 'No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with imlifidase.\n\nImlifidase: Immunoglobulin G degrading enzyme of Streptococcus pyogenes', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Plasma Exchange (PE) Treatment in Feeder Study 16-HMedIdeS-12', 'description': 'No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with PE.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Graft Survival at Year 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Imlifidase Treatment in Feeder Study 16-HMedIdeS-12', 'description': 'No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with imlifidase.\n\nImlifidase: Immunoglobulin G degrading enzyme of Streptococcus pyogenes'}, {'id': 'OG001', 'title': 'Plasma Exchange (PE) Treatment in Feeder Study 16-HMedIdeS-12', 'description': 'No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with PE.'}], 'classes': [{'categories': [{'title': 'Number of patients with a functioning graft', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Number of patients with graft loss', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Censored (patients being censored up to the time point)', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 years after start of AMR treatment in feeder study (16-HMedIdeS-12)', 'description': 'Graft survival is defined as time from start of AMR treatment in feeder study (16-HMedIdeS-12) to graft loss. Graft loss is defined as permanent return to dialysis for at least 6 weeks, re-transplantation, or nephrectomy.\n\nData table show number of patients with a functioning graft at Year 3.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the premature termination of the trial, 7 patients in the Imlifidase treatment group and 6 patients in the Plasma exchange treatment group had no graft survival data for the 3 year timepoint'}, {'type': 'SECONDARY', 'title': 'Overall Graft Survival at Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Imlifidase Treatment in Feeder Study 16-HMedIdeS-12', 'description': 'No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with imlifidase.\n\nImlifidase: Immunoglobulin G degrading enzyme of Streptococcus pyogenes'}, {'id': 'OG001', 'title': 'Plasma Exchange (PE) Treatment in Feeder Study 16-HMedIdeS-12', 'description': 'No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with PE.'}], 'classes': [{'categories': [{'title': 'Number of patients with a functioning graft', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Number of patients with graft loss', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Censored (patients being censored up to the time point)', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years after start of AMR treatment in feeder study (16-HMedIdeS-12)', 'description': 'Graft survival is defined as time from start of AMR treatment in feeder study (16-HMedIdeS-12) to graft loss. Graft loss is defined as permanent return to dialysis for at least 6 weeks, re-transplantation, or nephrectomy.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the premature termination of the trial, 6 patients in the Imlifidase treatment group and 4 patients in the Plasma exchange treatment group have no graft survival data for Year 2.'}, {'type': 'SECONDARY', 'title': 'Overall Graft Survival at Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Imlifidase Treatment in Feeder Study 16-HMedIdeS-12', 'description': 'No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with imlifidase.\n\nImlifidase: Immunoglobulin G degrading enzyme of Streptococcus pyogenes'}, {'id': 'OG001', 'title': 'Plasma Exchange (PE) Treatment in Feeder Study 16-HMedIdeS-12', 'description': 'No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with PE.'}], 'classes': [{'categories': [{'title': 'Number of patients with a functioning graft', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Number of patients with graft loss', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Censored (patients being censored up to the time point)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year after start of AMR treatment in feeder study (16-HMedIdeS-12)', 'description': 'Graft survival is defined as time from start of AMR treatment in feeder study (16-HMedIdeS-12) to graft loss. Graft loss is defined as permanent return to dialysis for at least 6 weeks, re-transplantation, or nephrectomy.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the premature termination of the trial, 1 patient in each treatment group have no data for Year 1.'}, {'type': 'SECONDARY', 'title': 'Patient Survival at Year 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Imlifidase Treatment in Feeder Study 16-HMedIdeS-12', 'description': 'No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with imlifidase.\n\nImlifidase: Immunoglobulin G degrading enzyme of Streptococcus pyogenes'}, {'id': 'OG001', 'title': 'Plasma Exchange (PE) Treatment in Feeder Study 16-HMedIdeS-12', 'description': 'No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with PE.'}], 'classes': [{'categories': [{'title': 'At risk (patients being at risk for event at the time point)', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Event (patients having events up to the time point)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Censored (patients being censored up to the time point)', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 years after start of AMR treatment in feeder study (16-HMedIdeS-12)', 'description': 'Overall patient survival is defined as time from start of AMR treatment in feeder study (16-HMedIdeS-12) to death for any cause.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the premature termination of the trial, 9 patients in the Imlifidase treatment group and 7 patients in the Plasma exchange treatment group have no survival data for the 3 year timepoint.'}, {'type': 'SECONDARY', 'title': 'Kidney Function as Evaluated by eGFR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Imlifidase Treatment in Feeder Study 16-HMedIdeS-12', 'description': 'No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with imlifidase.\n\nImlifidase: Immunoglobulin G degrading enzyme of Streptococcus pyogenes'}, {'id': 'OG001', 'title': 'Plasma Exchange (PE) Treatment in Feeder Study 16-HMedIdeS-12', 'description': 'No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with PE.'}], 'classes': [{'title': 'Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.1', 'spread': '20.9', 'groupId': 'OG000'}, {'value': '36.6', 'spread': '12.3', 'groupId': 'OG001'}]}]}, {'title': 'Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.2', 'spread': '6.4', 'groupId': 'OG000'}, {'value': '39.7', 'groupId': 'OG001'}]}]}, {'title': 'Year 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1, 2 and 3 years after start of AMR treatment in feeder study (16-HMedIdeS-12)', 'description': 'Estimated glomerular filtration rate (eGFR) was calculated as described by the Modification of Diet in Renal Disease Study (MDRD) equation. eGFR is a measure of kidney function. eGFR for a kidney with normal function is 90 mL/min/1.72m2. Kidney disease is characterised by a decreased eGFR value.', 'unitOfMeasure': 'mL/min/1.73 m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the premature termination of the trial a large proportion of the patients did not complete the trial and no data were collected for Year 3 in the "Plasma exchange treatment in feeder Study 16-HMedIdeS-12" arm.'}, {'type': 'SECONDARY', 'title': 'Kidney Function as Evaluated by S/P-creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Imlifidase Treatment in Feeder Study 16-HMedIdeS-12', 'description': 'No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with imlifidase.\n\nImlifidase: Immunoglobulin G degrading enzyme of Streptococcus pyogenes'}, {'id': 'OG001', 'title': 'Plasma Exchange (PE) Treatment in Feeder Study 16-HMedIdeS-12', 'description': 'No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with PE.'}], 'classes': [{'title': 'Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '297', 'groupId': 'OG000', 'lowerLimit': '81', 'upperLimit': '795'}, {'value': '187', 'groupId': 'OG001', 'lowerLimit': '102', 'upperLimit': '288'}]}]}, {'title': 'Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '130', 'groupId': 'OG000', 'lowerLimit': '107', 'upperLimit': '161'}, {'value': '187', 'groupId': 'OG001'}]}]}, {'title': 'Year 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '144', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1, 2 and 3 years after start of AMR treatment in feeder study (16-HMedIdeS-12)', 'description': 'S/P-creatinine is a measure of kidney function. Kidney disease is characterized by an increased S/P-creatinine level.', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to premature termination of the trial by the Sponsor, only very few patients had assessments at Year 2 and Year 3 and no data were collected for Year 3 in the "Plasma exchange treatment in feeder Study 16-HMedIdeS-12" arm.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Presumed or Biopsy Proven AMR Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Imlifidase Treatment in Feeder Study 16-HMedIdeS-12', 'description': 'No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with imlifidase.\n\nImlifidase: Immunoglobulin G degrading enzyme of Streptococcus pyogenes'}, {'id': 'OG001', 'title': 'Plasma Exchange (PE) Treatment in Feeder Study 16-HMedIdeS-12', 'description': 'No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with PE.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 years after start of AMR treatment in feeder study (16-HMedIdeS-12)', 'description': 'Information about rejection episodes will be collected, according to Banff 2017 or later classification. For-cause biopsies together with contemporaneous local DSA analyses, kidney function parameters (creatinine, albumin/creatinine ratio in urine) and treatments (e.g. plasma exchange and IVIg) will be collected to assess the rejection episodes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Presumed or Biopsy-proven Rejection Episodes (Other Than AMR Episodes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Imlifidase Treatment in Feeder Study 16-HMedIdeS-12', 'description': 'No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with imlifidase.\n\nImlifidase: Immunoglobulin G degrading enzyme of Streptococcus pyogenes'}, {'id': 'OG001', 'title': 'Plasma Exchange (PE) Treatment in Feeder Study 16-HMedIdeS-12', 'description': 'No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with PE.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 years after start of AMR treatment in feeder study (16-HMedIdeS-12)', 'description': 'Information about rejection episodes will be collected, according to Banff 2017 or later classification. For-cause biopsies together with contemporaneous local DSA analyses, kidney function parameters (creatinine, albumin/creatinine ratio in urine) and treatments (e.g. plasma exchange and IVIg) will be collected to assess the rejection episodes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'DSA Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Imlifidase Treatment in Feeder Study 16-HMedIdeS-12', 'description': 'No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with imlifidase.\n\nImlifidase: Immunoglobulin G degrading enzyme of Streptococcus pyogenes'}, {'id': 'OG001', 'title': 'Plasma Exchange (PE) Treatment in Feeder Study 16-HMedIdeS-12', 'description': 'No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with PE.'}], 'classes': [{'title': 'Visit 2 - feeder trial pre-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10764', 'spread': '7603', 'groupId': 'OG000'}, {'value': '15794', 'spread': '5897', 'groupId': 'OG001'}]}]}, {'title': '1 year post dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5964', 'spread': '5539', 'groupId': 'OG000'}, {'value': '3672', 'spread': '643', 'groupId': 'OG001'}]}]}, {'title': '2 years post dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2156', 'spread': '1025', 'groupId': 'OG000'}, {'value': '12362', 'groupId': 'OG001'}]}]}, {'title': '3 years post dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '974', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1, 2 and 3 years after start of AMR treatment in feeder study (16-HMedIdeS-12)', 'description': 'DSA levels will be measured using single antigen bead human leukocyte antigen (SAB-HLA) assay', 'unitOfMeasure': 'Mean Fluorescence Intensity', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to premature termination of the trial by the Sponsor, some patients have no DSA assessments done at Year 1, Year 2 and Year 3 and no data were collected for Year 3 in the "Plasma exchange treatment in feeder Study 16-HMedIdeS-12" arm.'}, {'type': 'SECONDARY', 'title': 'ADA Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Imlifidase Treatment in Feeder Study 16-HMedIdeS-12', 'description': 'No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with imlifidase.\n\nImlifidase: Immunoglobulin G degrading enzyme of Streptococcus pyogenes'}, {'id': 'OG001', 'title': 'Plasma Exchange (PE) Treatment in Feeder Study 16-HMedIdeS-12', 'description': 'No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with PE.'}], 'classes': [{'title': '1 year post dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75', 'spread': '405', 'groupId': 'OG000'}]}]}, {'title': '2 years post dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41', 'spread': '1426', 'groupId': 'OG000'}]}]}, {'title': '3 years post dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1,2 and 3 years after start of AMR treatment in feeder study (16-HMedIdeS-12)', 'description': 'The immunogenicity of imlifidase will be assessed by measuring ADA levels.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients exposed to imlifidase were assessed for anti-imlifidase antibodies (ADA).\n\nDue to premature termination of the trial by the Sponsor, some imlifidase treated patients have no ADA assessments done at Year 1, Year 2 and Year 3'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Imlifidase Treatment in Feeder Study 16-HMedIdeS-12', 'description': 'No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with imlifidase.\n\nImlifidase: Immunoglobulin G degrading enzyme of Streptococcus pyogenes'}, {'id': 'FG001', 'title': 'Plasma Exchange (PE) Treatment in Feeder Study 16-HMedIdeS-12', 'description': 'No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with PE.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Graft loss', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Patient not eligible as no AMR in feeder trial', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Sponsor decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Imlifidase Treatment in Feeder Study 16-HMedIdeS-12', 'description': 'No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with imlifidase.\n\nImlifidase: Immunoglobulin G degrading enzyme of Streptococcus pyogenes'}, {'id': 'BG001', 'title': 'Plasma Exchange (PE) Treatment in Feeder Study 16-HMedIdeS-12', 'description': 'No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with PE.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.9', 'spread': '17.6', 'groupId': 'BG000'}, {'value': '48.0', 'spread': '13.5', 'groupId': 'BG001'}, {'value': '46.7', 'spread': '15.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Austria', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '27.1', 'spread': '6.9', 'groupId': 'BG000'}, {'value': '29.0', 'spread': '7.1', 'groupId': 'BG001'}, {'value': '27.8', 'spread': '6.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-22', 'size': 820834, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-02-25T06:40', 'hasProtocol': True}, {'date': '2023-05-12', 'size': 486548, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-02-25T06:39', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples collected for DSA and ADA may be stored for a maximum of 5 years after completion of the trial.\n\nA full chain of custody is maintained for all samples throughout their life cycle.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'This is an internal decision based on prioritisations and no safety issues have been raised during the trial.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-16', 'studyFirstSubmitDate': '2021-01-13', 'resultsFirstSubmitDate': '2025-02-25', 'studyFirstSubmitQcDate': '2021-01-13', 'lastUpdatePostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-25', 'studyFirstPostDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Graft Survival at Year 3', 'timeFrame': '3 years after start of AMR treatment in feeder study (16-HMedIdeS-12)', 'description': 'Graft survival is defined as time from start of AMR treatment in feeder study (16-HMedIdeS-12) to graft loss. Graft loss is defined as permanent return to dialysis for at least 6 weeks, re-transplantation, or nephrectomy.\n\nData table show number of patients with a functioning graft at Year 3.'}], 'secondaryOutcomes': [{'measure': 'Overall Graft Survival at Year 2', 'timeFrame': '2 years after start of AMR treatment in feeder study (16-HMedIdeS-12)', 'description': 'Graft survival is defined as time from start of AMR treatment in feeder study (16-HMedIdeS-12) to graft loss. Graft loss is defined as permanent return to dialysis for at least 6 weeks, re-transplantation, or nephrectomy.'}, {'measure': 'Overall Graft Survival at Year 1', 'timeFrame': '1 year after start of AMR treatment in feeder study (16-HMedIdeS-12)', 'description': 'Graft survival is defined as time from start of AMR treatment in feeder study (16-HMedIdeS-12) to graft loss. Graft loss is defined as permanent return to dialysis for at least 6 weeks, re-transplantation, or nephrectomy.'}, {'measure': 'Patient Survival at Year 3', 'timeFrame': '3 years after start of AMR treatment in feeder study (16-HMedIdeS-12)', 'description': 'Overall patient survival is defined as time from start of AMR treatment in feeder study (16-HMedIdeS-12) to death for any cause.'}, {'measure': 'Kidney Function as Evaluated by eGFR', 'timeFrame': '1, 2 and 3 years after start of AMR treatment in feeder study (16-HMedIdeS-12)', 'description': 'Estimated glomerular filtration rate (eGFR) was calculated as described by the Modification of Diet in Renal Disease Study (MDRD) equation. eGFR is a measure of kidney function. eGFR for a kidney with normal function is 90 mL/min/1.72m2. Kidney disease is characterised by a decreased eGFR value.'}, {'measure': 'Kidney Function as Evaluated by S/P-creatinine', 'timeFrame': '1, 2 and 3 years after start of AMR treatment in feeder study (16-HMedIdeS-12)', 'description': 'S/P-creatinine is a measure of kidney function. Kidney disease is characterized by an increased S/P-creatinine level.'}, {'measure': 'Number of Participants With Presumed or Biopsy Proven AMR Episodes', 'timeFrame': '3 years after start of AMR treatment in feeder study (16-HMedIdeS-12)', 'description': 'Information about rejection episodes will be collected, according to Banff 2017 or later classification. For-cause biopsies together with contemporaneous local DSA analyses, kidney function parameters (creatinine, albumin/creatinine ratio in urine) and treatments (e.g. plasma exchange and IVIg) will be collected to assess the rejection episodes.'}, {'measure': 'Number of Participants With Presumed or Biopsy-proven Rejection Episodes (Other Than AMR Episodes)', 'timeFrame': '3 years after start of AMR treatment in feeder study (16-HMedIdeS-12)', 'description': 'Information about rejection episodes will be collected, according to Banff 2017 or later classification. For-cause biopsies together with contemporaneous local DSA analyses, kidney function parameters (creatinine, albumin/creatinine ratio in urine) and treatments (e.g. plasma exchange and IVIg) will be collected to assess the rejection episodes.'}, {'measure': 'DSA Levels', 'timeFrame': '1, 2 and 3 years after start of AMR treatment in feeder study (16-HMedIdeS-12)', 'description': 'DSA levels will be measured using single antigen bead human leukocyte antigen (SAB-HLA) assay'}, {'measure': 'ADA Levels', 'timeFrame': '1,2 and 3 years after start of AMR treatment in feeder study (16-HMedIdeS-12)', 'description': 'The immunogenicity of imlifidase will be assessed by measuring ADA levels.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kidney Transplant Rejection']}, 'referencesModule': {'references': [{'pmid': '39023092', 'type': 'DERIVED', 'citation': 'Halleck F, Bohmig GA, Couzi L, Rostaing L, Einecke G, Lefaucheur C, Legendre C, Montgomery R, Hughes P, Chandraker A, Wyburn K, Halloran P, Maldonado AQ, Sjoholm K, Runstrom A, Lefevre P, Tollemar J, Jordan S. A Randomized Trial Comparing Imlifidase to Plasmapheresis in Kidney Transplant Recipients With Antibody-Mediated Rejection. Clin Transplant. 2024 Jul;38(7):e15383. doi: 10.1111/ctr.15383.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this trial is to collect data and provide a better understanding of the long-term outcome of imlifidase treatment on active or chronic active antibody-mediated rejection (AMR) in kidney transplant recipients. This is done by collecting data during an extended follow-up period of 3 years of clinical study trial 16-HMedIdeS-12, in which patients received either imlifidase or plasma exchange (PE) as AMR treatment. Data for parameters such as kidney graft survival, patient survival, kidney function, treatment of rebound of donor specific antibodies (DSA) and anti-drug antibodies (ADAs) are collected.', 'detailedDescription': 'AMR is one of the most challenging adverse events following kidney transplantation and a major cause of graft dysfunction and graft loss. AMR is triggered by donor-specific antibodies (DSA).Transplant glomerulopathy is a known consequence of persistent DSA positivity which results in graft failure and return to dialysis with attendant consequences for the patient and financial costs for the health care system.\n\nThe time from transplantation to onset of clinical symptoms of AMR varies largely between individuals. An early AMR (\\<30 days post-transplant) is commonly classified as active AMR and most often triggered by an immunological recall response with pre-existing DSA. A late AMR (\\>30 days post-transplant) is classified as either active or chronic active AMR and is caused by either a recall DSA response or newly developing naïve immune response associated with de novo DSA production.\n\nThere is no currently approved therapy for AMR and patients are often treated with a combination of therapies i.e., high dose IVIg +/- rituximab, PE with low dose IVIg +/- rituximab, and eculizumab which makes analysis of efficacy of any single agent difficult. Hence, there is a large unmet clinical need for new therapies to treat AMR.\n\nImlifidase is an IgG-degrading enzyme of Streptococcus pyogenes that cleaves all four human subclasses of IgG with high efficacy and specificity. The rapidity of the IgG cleavage by imlifidase is considered a major advantage as compared with PE, which often requires several rounds over several days to achieve a sufficient DSA reduction. Within a few hours after imlifidase dosing, the entire pool of IgG is completely cleaved and thereby a window where IgG levels are kept very low for approximately one week is created.\n\nThe short-term efficacy and safety of imlifidase in active and chronic active AMR is being investigated in a randomized, open-label, multi-centre trial, using PE as an active control (i.e. the feeder study: 16-HMedIdeS-12). A total of 30 subjects will be included in this study (20 in the imlifidase arm and 10 in the plasma exchange arm). The primary objective is to investigate the efficacy of imlifidase in removing DSA in patients who are experiencing an AMR episode after kidney transplantation.\n\nWhile a rapid removal of DSA by imlifidase might be expected, DSA is likely to rebound unless well-controlled by concomitant immunosuppressive therapy. Therefore, there is also a need to address the long-term outcome of imlifidase as an AMR therapy. This will be studied during an extended follow-up period of 3 years in this study. Data for parameters such as kidney graft survival, patient survival, kidney function, treatment of rebound of donor specific antibodies (DSA) and anti-drug antibodies (ADAs) will be collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have been treated with imlifidase or plasma exchange in the feeder study 16-HMedIdeS-12 may be included.', '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* Previous treatment with imlifidase or plasma exchange in the trial 16-HMedIdeS-12\n\nNote: The primary objective of this trial is overall graft survival after treatment with imlifidase or plasma exchange. Therefore, subjects can also be included even if the subject did not fully complete the feeder trial follow up but was dosed with imlifidase or plasma exchange in the trial 16-HMedIdeS-12.\n\nExclusion Criteria:\n\n• Inability by the judgement of the investigator to participate in the trial for any other reason'}, 'identificationModule': {'nctId': 'NCT04711850', 'briefTitle': 'An Long-term Follow-up Trial of Kidney Tx Patients Treated With Imlifidase or PE After an AMR', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hansa Biopharma AB'}, 'officialTitle': 'A Prospective, Observational Long-term Follow-up Trial of Kidney Transplant Patients Treated With Imlifidase or Plasma Exchange After an Active/Chronic Active Antibody-Mediated Rejection Episode', 'orgStudyIdInfo': {'id': '20-HMedIdes-18'}, 'secondaryIdInfos': [{'id': '2020-004777-49', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Imlifidase treatment in feeder Study 16-HMedIdeS-12', 'description': 'No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with imlifidase.', 'interventionNames': ['Drug: Imlifidase']}, {'label': 'Plasma exchange (PE) treatment in feeder Study 16-HMedIdeS-12', 'description': 'No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with PE.'}], 'interventions': [{'name': 'Imlifidase', 'type': 'DRUG', 'otherNames': ['IdeS, HMED-IdeS'], 'description': 'Immunoglobulin G degrading enzyme of Streptococcus pyogenes', 'armGroupLabels': ['Imlifidase treatment in feeder Study 16-HMedIdeS-12']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Universitätsklinik für Innere Medizin III, Klinische Abteilung für Nephrologie MUW', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Hôpital Pellegrin', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'CHU Grenoble Alpes - Néphrologie, dialyse et transplantation', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '75475', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Saint-Louis. Service de Néphrologie et Transplantation', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75742', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Necker - Service de Néphrologie - Transplantation', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité-Universitätsmedizin. Dept. of Nephrology and Medical Intensive Care', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Hanover', 'country': 'Germany', 'facility': 'Medizinische Hochschule Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}], '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'}}}}