Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-28 @ 3:58 PM
Study NCT ID:
NCT05049850
Status:
TERMINATED
Last Update Posted:
2025-10-21
First Post:
2021-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Investigate DSA Rebound in Patients Treated With Imlifidase Prior to Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'C442815', 'term': 'Mac-1-like protein, Streptococcus'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicalstudyinfo@hansabiopharma.com', 'phone': '+46 46 16 56 70', 'title': 'Study Director', 'organization': 'Hansa Biopharma AB'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AEs were collected on the AE CRF for each patient, from the time of signing of the informed consent and throughout the trial including the follow-up period. 35 Days in screening phase plus 181 Days in trial, a total of 216 Days.', 'eventGroups': [{'id': 'EG000', 'title': 'Imlifidase', 'description': 'Imlifidase is administered intravenously as one dose of 0.25 mg/kg over 15 minutes within the 24-hour period prior to transplantation. (A second dose may be given if the crossmatch test at 4 hours after the first dose remains positive.)', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Abdominal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Delayed graft function', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Renal infarct', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}], 'seriousEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Post procedural discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Wound evisceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Donor specific antibody present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'International normalised ratio increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Patients With DSA Rebound', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Imlifidase', 'description': 'Imlifidase is administered intravenously as one dose of 0.25 mg/kg over 15 minutes within the 24-hour period prior to transplantation. (A second dose may be given if the crossmatch test at 4 hours after the first dose remains positive.)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 3 months after transplantation', 'description': 'The recurrence of DSA may cause AMR and increased risk of graft loss. Due to the early termination of the trial the primary endpoint was assessed as the incidence of DSA rebound of either immunodominant or total DSA to a mean fluorescence intensity (MFI) level that was ≥50% of the pre-imlifidase value up to 3 months after transplantation (trial day 91).', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients With Kidney Biopsy Proven AMR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Imlifidase', 'description': 'Imlifidase is administered intravenously as one dose of 0.25 mg/kg over 15 minutes within the 24-hour period prior to transplantation. (A second dose may be given if the crossmatch test at 4 hours after the first dose remains positive.)'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 6 months after transplantation', 'description': 'The standardized international Banff classification 2019 for assessment of renal allograft biopsies will be used to assess AMRs reported from the study based on for cause and protocol biopsies.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Patient With DSA Rebound', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Imlifidase', 'description': 'Imlifidase is administered intravenously as one dose of 0.25 mg/kg over 15 minutes within the 24-hour period prior to transplantation. (A second dose may be given if the crossmatch test at 4 hours after the first dose remains positive.)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 6 months after transplantation', 'description': 'See description to primary outcome measure', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients With Negative FCXM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Imlifidase', 'description': 'Imlifidase is administered intravenously as one dose of 0.25 mg/kg over 15 minutes within the 24-hour period prior to transplantation. (A second dose may be given if the crossmatch test at 4 hours after the first dose remains positive.)'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 24 hours after imlifidase treatment', 'description': 'Imlifidase is highly efficacious in converting a positive crossmatch to a negative', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Levels of DSA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Imlifidase', 'description': 'Imlifidase is administered intravenously as one dose of 0.25 mg/kg over 15 minutes within the 24-hour period prior to transplantation. (A second dose may be given if the crossmatch test at 4 hours after the first dose remains positive.)'}], 'classes': [{'title': 'Patient 1, pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22311', 'groupId': 'OG000'}]}]}, {'title': 'Patient 1, Day 181', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8619', 'groupId': 'OG000'}]}]}, {'title': 'Patient 2, pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8526', 'groupId': 'OG000'}]}]}, {'title': 'Patient 2, Day 139', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2172', 'groupId': 'OG000'}]}]}, {'title': 'Patient 3, pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9994', 'groupId': 'OG000'}]}]}, {'title': 'Patient 3, Day 181', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '149', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 4 hours before imlifidase until Day 181', 'description': "Analysis of DSAs before and after imlifidase will be done. The mean fluorescence intensity (MFI) will be presented for the individual patients' DSAs.", 'unitOfMeasure': 'MFI', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 2 of 3 patients had data for DSA collected at the Day 181 timepoint, for patient 2 data from an unscheduled visit at day 139 is presented.'}, {'type': 'SECONDARY', 'title': 'Levels of Complement Binding (C1q) DSA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Imlifidase', 'description': 'Imlifidase is administered intravenously as one dose of 0.25 mg/kg over 15 minutes within the 24-hour period prior to transplantation. (A second dose may be given if the crossmatch test at 4 hours after the first dose remains positive.)'}], 'timeFrame': 'Within 4 hours before imlifidase until Day 181', 'description': "Analysis of C1q DSAs before and after imlifidase will be done. The mean fluorescence intensity (MFI) will be presented for the individual patients' C1q DSAs.", 'reportingStatus': 'POSTED', 'populationDescription': 'Samples for assessment of DSA, including Cq1 DSA, were collected. However, the central laboratory assigned to Cq1 DSA analyzes was never activated due to the premature trial termination, hence analysis of Cq1 DSA was not performed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Graft Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Imlifidase', 'description': 'Imlifidase is administered intravenously as one dose of 0.25 mg/kg over 15 minutes within the 24-hour period prior to transplantation. (A second dose may be given if the crossmatch test at 4 hours after the first dose remains positive.)'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months after transplantation', 'description': 'Graft survival will be summarized by end of trial.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patients Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Imlifidase', 'description': 'Imlifidase is administered intravenously as one dose of 0.25 mg/kg over 15 minutes within the 24-hour period prior to transplantation. (A second dose may be given if the crossmatch test at 4 hours after the first dose remains positive.)'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months after transplantation', 'description': 'Patient survival will be summarized by end of trial.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Imlifidase', 'description': 'Imlifidase is administered intravenously as one dose of 0.25 mg/kg over 15 minutes within the 24-hour period prior to transplantation. (A second dose may be given if the crossmatch test at 4 hours after the first dose remains positive.)'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 6 months after transplantation', 'description': 'Safety is assessed as type, frequency and intensity of adverse events (AEs)/serious adverse events (SAEs) including clinically relevant changes in clinical laboratory tests, vital signs and ECG)', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Results for adverse events is presented in the section Reported Adverse Events.'}, {'type': 'SECONDARY', 'title': 'Kidney Function Assessed by Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Imlifidase', 'description': 'Imlifidase is administered intravenously as one dose of 0.25 mg/kg over 15 minutes within the 24-hour period prior to transplantation. (A second dose may be given if the crossmatch test at 4 hours after the first dose remains positive.)'}], 'classes': [{'title': 'Pre-dose', 'categories': [{'measurements': [{'value': '506', 'groupId': 'OG000', 'lowerLimit': '305', 'upperLimit': '682'}]}]}, {'title': 'Day 181', 'categories': [{'measurements': [{'value': '180', 'groupId': 'OG000', 'lowerLimit': '91', 'upperLimit': '184'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 6 months after transplantation', 'description': 'P-creatinine is a measure of kidney function.', 'unitOfMeasure': 'μmol/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Kidney Function Assessed by Estimated Glomerular Filtration Rate (eGFR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Imlifidase', 'description': 'Imlifidase is administered intravenously as one dose of 0.25 mg/kg over 15 minutes within the 24-hour period prior to transplantation. (A second dose may be given if the crossmatch test at 4 hours after the first dose remains positive.)'}], 'classes': [{'title': 'Pre-dose', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '14'}]}]}, {'title': 'Day 181', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000', 'lowerLimit': '26', 'upperLimit': '60'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 6 months after transplantation', 'description': 'Estimated glomerular filtration rate (eGFR) is a measure of kidney function. eGFR will be calculated as described by the modification of diet in renal disease (MDRD) equation.\n\neGFR for a kidney with normal function is 90 mL/min/1.73m2. Kidney disease is characterized by a decreased eGFR value.', 'unitOfMeasure': 'mL/min/1.73m2', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Kidney Function Assessed by Protein/Creatinine Ratio in Urine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Imlifidase', 'description': 'Imlifidase is administered intravenously as one dose of 0.25 mg/kg over 15 minutes within the 24-hour period prior to transplantation. (A second dose may be given if the crossmatch test at 4 hours after the first dose remains positive.)'}], 'classes': [{'title': '24h post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2158', 'groupId': 'OG000', 'lowerLimit': '1900', 'upperLimit': '120025'}]}]}, {'title': 'Day 181', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1233', 'groupId': 'OG000', 'lowerLimit': '470', 'upperLimit': '1996'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 6 months after transplantation', 'description': 'The protein/creatinine ratio in urine is a measure of kidney function. Will be measured unless patients are anuric.', 'unitOfMeasure': 'mg/g', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 2 of the 3 patients had data collected at the Day 181 timepoint.'}, {'type': 'SECONDARY', 'title': 'Imlifidase Pharmacokinetics (AUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Imlifidase', 'description': 'Imlifidase is administered intravenously as one dose of 0.25 mg/kg over 15 minutes within the 24-hour period prior to transplantation. (A second dose may be given if the crossmatch test at 4 hours after the first dose remains positive.)'}], 'classes': [{'categories': [{'measurements': [{'value': '71.9', 'groupId': 'OG000', 'lowerLimit': '65.6', 'upperLimit': '119'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Within 4 hours before imlifidase dose until Day 15', 'description': 'AUC = Area under the imlifidase plasma concentration versus time curve', 'unitOfMeasure': 'h×μg/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Imlifidase Pharmacokinetics (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Imlifidase', 'description': 'Imlifidase is administered intravenously as one dose of 0.25 mg/kg over 15 minutes within the 24-hour period prior to transplantation. (A second dose may be given if the crossmatch test at 4 hours after the first dose remains positive.)'}], 'classes': [{'categories': [{'measurements': [{'value': '3.70', 'groupId': 'OG000', 'lowerLimit': '3.20', 'upperLimit': '4.10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Within 4 hours before imlifidase dose until Day 15', 'description': 'Cmax = Maximum observed plasma concentration of imlifidase following dosing', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Imlifidase Pharmacokinetics (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Imlifidase', 'description': 'Imlifidase is administered intravenously as one dose of 0.25 mg/kg over 15 minutes within the 24-hour period prior to transplantation. (A second dose may be given if the crossmatch test at 4 hours after the first dose remains positive.)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.13', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '1.25'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Within 4 hours before imlifidase dose until Day 15', 'description': 'tmax = Time point for maximum observed plasma concentration of imlifidase following dosing', 'unitOfMeasure': 'h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Imlifidase Pharmacokinetics (t1/2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Imlifidase', 'description': 'Imlifidase is administered intravenously as one dose of 0.25 mg/kg over 15 minutes within the 24-hour period prior to transplantation. (A second dose may be given if the crossmatch test at 4 hours after the first dose remains positive.)'}], 'classes': [{'title': 't1/2 alpha', 'categories': [{'measurements': [{'value': '6.40', 'groupId': 'OG000', 'lowerLimit': '1.05', 'upperLimit': '9.29'}]}]}, {'title': 't1/2 beta', 'categories': [{'measurements': [{'value': '28.3', 'groupId': 'OG000', 'lowerLimit': '26.7', 'upperLimit': '37.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Within 4 hours before imlifidase dose until Day 15', 'description': 't1/2 = Terminal half-life of imlifidase, the time taken for concentration of imlifidase to decrease from its maximum concentration (Cmax) to half of Cmax in the blood plasma.\n\nt1/2 alpha = alpha phase (distribution/elimination) half-life, an initial phase of rapid decrease in plasma concentration.\n\nt1/2 beta = beta phase (elimination) half-life, a phase of gradual decrease in plasma concentration after the alpha phase.', 'unitOfMeasure': 'h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Imlifidase Pharmacokinetics (CL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Imlifidase', 'description': 'Imlifidase is administered intravenously as one dose of 0.25 mg/kg over 15 minutes within the 24-hour period prior to transplantation. (A second dose may be given if the crossmatch test at 4 hours after the first dose remains positive.)'}], 'classes': [{'categories': [{'measurements': [{'value': '3.48', 'groupId': 'OG000', 'lowerLimit': '2.11', 'upperLimit': '3.81'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Within 4 hours before imlifidase dose until Day 15', 'description': 'CL = Clearance of imlifidase', 'unitOfMeasure': 'mL/h/kg', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Imlifidase Pharmacokinetics (Vz)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Imlifidase', 'description': 'Imlifidase is administered intravenously as one dose of 0.25 mg/kg over 15 minutes within the 24-hour period prior to transplantation. (A second dose may be given if the crossmatch test at 4 hours after the first dose remains positive.)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.142', 'groupId': 'OG000', 'lowerLimit': '0.081', 'upperLimit': '0.205'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Within 4 hours before imlifidase dose until Day 15', 'description': 'Vz = Apparent volume of distribution during terminal phase', 'unitOfMeasure': 'L/kg', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pharmacodynamics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Imlifidase', 'description': 'Imlifidase is administered intravenously as one dose of 0.25 mg/kg over 15 minutes within the 24-hour period prior to transplantation. (A second dose may be given if the crossmatch test at 4 hours after the first dose remains positive.)'}], 'classes': [{'title': 'Pre-dose', 'categories': [{'measurements': [{'value': '11.6', 'groupId': 'OG000', 'lowerLimit': '5.2', 'upperLimit': '15.7'}]}]}, {'title': 'Day 10', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '3.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Within 4 hours before imlifidase dose until Day 10', 'description': 'Concentration of IgG in patient serum will be measured. Scoring of IgG fragments will be done.', 'unitOfMeasure': 'g/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Anti-drug Antibodies (ADA) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Imlifidase', 'description': 'Imlifidase is administered intravenously as one dose of 0.25 mg/kg over 15 minutes within the 24-hour period prior to transplantation. (A second dose may be given if the crossmatch test at 4 hours after the first dose remains positive.)'}], 'classes': [{'title': 'Pre-dose', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '2.4', 'upperLimit': '82.9'}]}]}, {'title': 'Day 181', 'categories': [{'measurements': [{'value': '20.5', 'groupId': 'OG000', 'lowerLimit': '13.7', 'upperLimit': '30.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 6 months after imlifidase', 'description': 'Immunogenicity towards imlifidase will be assessed by the measurement of ADA levels in patient serum using a customized ImmunoCAP analysis.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Patient-reported Life Participation, as Measured PROMIS-SF-8a', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Imlifidase', 'description': 'Imlifidase is administered intravenously as one dose of 0.25 mg/kg over 15 minutes within the 24-hour period prior to transplantation. (A second dose may be given if the crossmatch test at 4 hours after the first dose remains positive.)'}], 'classes': [{'title': 'Screening', 'categories': [{'measurements': [{'value': '53.6', 'groupId': 'OG000', 'lowerLimit': '44', 'upperLimit': '54.6'}]}]}, {'title': 'Day 181', 'categories': [{'measurements': [{'value': '65.4', 'groupId': 'OG000', 'lowerLimit': '60.2', 'upperLimit': '65.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At screening and Day 181', 'description': 'The PROMIS Social Health domain "Ability to participate in social roles \\& activities PROMIS-SF-8" will be used as a measure of the patients\' health related quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PROMIS-SF-8 sores are calculate using the PROMIS® Short Form v2.0-Ability to Participate in Social Roles and Activities 8a scoring manual. The total scale raw score was translated into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10, i.e. a T-score of 40 is one SD below the mean. The lowest possible T-score is 25.9 and the highest possible score is 65.4, a higher score means a better outcome.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Imlifidase', 'description': 'Imlifidase is administered intravenously as one dose of 0.25 mg/kg over 15 minutes within the 24-hour period prior to transplantation. (A second dose may be given if the crossmatch test at 4 hours after the first dose remains positive.)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The Sponsor decided to prematurely terminate the trial after 3 of the 12 patients had been treated and transplanted in the trial due to prioritization of internal resources. This decision was unrelated to either safety or efficacy, no safety issues were raised during the conduct of the trial.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Imlifidase', 'description': 'Imlifidase is administered intravenously as one dose of 0.25 mg/kg over 15 minutes within the 24-hour period prior to transplantation. (A second dose may be given if the crossmatch test at 4 hours after the first dose remains positive.)'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-23', 'size': 943923, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-03-05T06:05', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Company decision, not due to any safety reason', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-03', 'studyFirstSubmitDate': '2021-09-09', 'resultsFirstSubmitDate': '2025-02-04', 'studyFirstSubmitQcDate': '2021-09-09', 'lastUpdatePostDateStruct': {'date': '2025-10-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-03-07', 'studyFirstPostDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Patients With DSA Rebound', 'timeFrame': 'Up to 3 months after transplantation', 'description': 'The recurrence of DSA may cause AMR and increased risk of graft loss. Due to the early termination of the trial the primary endpoint was assessed as the incidence of DSA rebound of either immunodominant or total DSA to a mean fluorescence intensity (MFI) level that was ≥50% of the pre-imlifidase value up to 3 months after transplantation (trial day 91).'}], 'secondaryOutcomes': [{'measure': 'Proportion of Patients With Kidney Biopsy Proven AMR', 'timeFrame': 'Up to 6 months after transplantation', 'description': 'The standardized international Banff classification 2019 for assessment of renal allograft biopsies will be used to assess AMRs reported from the study based on for cause and protocol biopsies.'}, {'measure': 'Proportion of Patient With DSA Rebound', 'timeFrame': 'Up to 6 months after transplantation', 'description': 'See description to primary outcome measure'}, {'measure': 'Proportion of Patients With Negative FCXM', 'timeFrame': 'Up to 24 hours after imlifidase treatment', 'description': 'Imlifidase is highly efficacious in converting a positive crossmatch to a negative'}, {'measure': 'Levels of DSA', 'timeFrame': 'Within 4 hours before imlifidase until Day 181', 'description': "Analysis of DSAs before and after imlifidase will be done. The mean fluorescence intensity (MFI) will be presented for the individual patients' DSAs."}, {'measure': 'Levels of Complement Binding (C1q) DSA', 'timeFrame': 'Within 4 hours before imlifidase until Day 181', 'description': "Analysis of C1q DSAs before and after imlifidase will be done. The mean fluorescence intensity (MFI) will be presented for the individual patients' C1q DSAs."}, {'measure': 'Number of Participants With Graft Survival', 'timeFrame': '6 months after transplantation', 'description': 'Graft survival will be summarized by end of trial.'}, {'measure': 'Patients Survival', 'timeFrame': '6 months after transplantation', 'description': 'Patient survival will be summarized by end of trial.'}, {'measure': 'Number of Participants With Adverse Events (AEs)', 'timeFrame': 'Up to 6 months after transplantation', 'description': 'Safety is assessed as type, frequency and intensity of adverse events (AEs)/serious adverse events (SAEs) including clinically relevant changes in clinical laboratory tests, vital signs and ECG)'}, {'measure': 'Kidney Function Assessed by Creatinine', 'timeFrame': 'Up to 6 months after transplantation', 'description': 'P-creatinine is a measure of kidney function.'}, {'measure': 'Kidney Function Assessed by Estimated Glomerular Filtration Rate (eGFR)', 'timeFrame': 'Up to 6 months after transplantation', 'description': 'Estimated glomerular filtration rate (eGFR) is a measure of kidney function. eGFR will be calculated as described by the modification of diet in renal disease (MDRD) equation.\n\neGFR for a kidney with normal function is 90 mL/min/1.73m2. Kidney disease is characterized by a decreased eGFR value.'}, {'measure': 'Kidney Function Assessed by Protein/Creatinine Ratio in Urine', 'timeFrame': 'Up to 6 months after transplantation', 'description': 'The protein/creatinine ratio in urine is a measure of kidney function. Will be measured unless patients are anuric.'}, {'measure': 'Imlifidase Pharmacokinetics (AUC)', 'timeFrame': 'Within 4 hours before imlifidase dose until Day 15', 'description': 'AUC = Area under the imlifidase plasma concentration versus time curve'}, {'measure': 'Imlifidase Pharmacokinetics (Cmax)', 'timeFrame': 'Within 4 hours before imlifidase dose until Day 15', 'description': 'Cmax = Maximum observed plasma concentration of imlifidase following dosing'}, {'measure': 'Imlifidase Pharmacokinetics (Tmax)', 'timeFrame': 'Within 4 hours before imlifidase dose until Day 15', 'description': 'tmax = Time point for maximum observed plasma concentration of imlifidase following dosing'}, {'measure': 'Imlifidase Pharmacokinetics (t1/2)', 'timeFrame': 'Within 4 hours before imlifidase dose until Day 15', 'description': 't1/2 = Terminal half-life of imlifidase, the time taken for concentration of imlifidase to decrease from its maximum concentration (Cmax) to half of Cmax in the blood plasma.\n\nt1/2 alpha = alpha phase (distribution/elimination) half-life, an initial phase of rapid decrease in plasma concentration.\n\nt1/2 beta = beta phase (elimination) half-life, a phase of gradual decrease in plasma concentration after the alpha phase.'}, {'measure': 'Imlifidase Pharmacokinetics (CL)', 'timeFrame': 'Within 4 hours before imlifidase dose until Day 15', 'description': 'CL = Clearance of imlifidase'}, {'measure': 'Imlifidase Pharmacokinetics (Vz)', 'timeFrame': 'Within 4 hours before imlifidase dose until Day 15', 'description': 'Vz = Apparent volume of distribution during terminal phase'}, {'measure': 'Pharmacodynamics', 'timeFrame': 'Within 4 hours before imlifidase dose until Day 10', 'description': 'Concentration of IgG in patient serum will be measured. Scoring of IgG fragments will be done.'}, {'measure': 'Anti-drug Antibodies (ADA) Levels', 'timeFrame': 'Up to 6 months after imlifidase', 'description': 'Immunogenicity towards imlifidase will be assessed by the measurement of ADA levels in patient serum using a customized ImmunoCAP analysis.'}, {'measure': 'Change in Patient-reported Life Participation, as Measured PROMIS-SF-8a', 'timeFrame': 'At screening and Day 181', 'description': 'The PROMIS Social Health domain "Ability to participate in social roles \\& activities PROMIS-SF-8" will be used as a measure of the patients\' health related quality of life.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Highly sensitized', 'Kidney transplantation', 'Renal transplantation'], 'conditions': ['Kidney Transplantation in Highly Sensitized Patients']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess whether imlifidase in combination with bortezomib, belatacept, rituximab and IVIg can suppress donor specific antibodies (DSA) and the occurrence of antibody-mediated rejection (AMR) in highly sensitized patients with chronic kidney disease with a positive crossmatch towards their living donor during a period of 3 months from transplantation.', 'detailedDescription': "Imlifidase is an immunoglobulin G (IgG)-degrading enzyme of Streptococcus pyogenes that is highly specific for IgG. The cleavage of IgG generates one F(ab')2- and one homodimeric Fc-fragment and efficiently neutralizes Fc-mediated activities of IgG. Clinical studies with imlifidase have demonstrated that the treatment enables transplantation in patients otherwise highly unlikely to be transplanted, by converting a positive crossmatch to a negative.\n\nHowever, as with other desensitization methods, DSA tend to reappear within weeks after treatment and transplantation, which may cause AMR and increased risk of graft loss. In this study, treatment with imlifidase in combination with approved drugs that prevent or suppress DSA rebound by targeting antibody-producing plasma-cells and their B-cell precursors is suggested. These drugs include (i) bortezomib, a proteasome inhibitor which has activity against mature plasma cells, the source of DSA, (ii) belatacept, a fusion protein which is crucial in blocking T-cell co-stimulation and which is effective in reducing de novo DSA generation in humans, (iii) rituximab, an anti-CD20 monoclonal antibody that targets B-cells and which is an immunomodulatory agent, and (iv) intravenous immunoglobulin (IVIg) which is commonly used in desensitization regimens and for the treatment of AMR.\n\nAfter being informed about the study and potential risks, all patients giving written informed consent will undergo a 2-week screening period to determine eligibility for study entry. Patients who meet the eligibility requirements will then start treatment with belatacept and bortezomib about 3 weeks prior to the imlifidase infusion and transplantation. Rituximab will be initiated 8 days after transplantation and IVIg 10 days after transplantation. Induction and maintenance immunosuppression will also be administered. The patients will be hospitalized for approximately 2 weeks following transplantation and after that 9 follow-up visits to the clinic will take place up to 6 months after transplantation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed Informed Consent obtained before any trial-related procedures\n* Male or female age 18 to 70 years at the time of screening\n* Highly sensitized patients registered on the UNOS waiting list for kidney transplantation, with either of the following:\n\n * cPRA ≥ 99.9%\n * cPRA ≥ 98% and have been in kidney paired donation or kidney paired exchange programs for at least 1 year\n* A positive crossmatch towards a living donor\n* Willingness and ability to comply with the protocol\n\nExclusion Criteria:\n\n* Previous treatment with imlifidase\n* Previous high dose IVIg treatment (2 g/kg) within 28 days prior to imlifidase treatment\n* Breast-feeding or pregnancy\n* Women of child-bearing potential not willing or able to practice FDA-approved forms of contraception. Two medically acceptable methods of highly effective contraception must be used for the duration of the study (e.g. oral, transdermal, intravaginal, injectable or implantable contraceptive; intrauterine device; intrauterine hormone-releasing system; vasectomized partner; bilateral tubal occlusion; or double-barrier method). For a woman to be considered postmenopausal this ascertainment must be made according to medical records and clinical history and may be aided by measurement of elevated postmenopausal serum gonadotropin levels (FSH).\n* ABO blood group incompatible transplantations (A2 and A2B kidneys will not be accepted for B recipients)\n* Positive serology for HIV\n* Clinical signs of HBV, HCV, CMV, or EBV infection\n* EBV seronegative or with unknown EBV serostatus\n* Positive SARS-CoV-2 tests at any time point from screening to transplantation\n* Active tuberculosis\n* Ongoing serious infections as judged by the investigator\n* Severe other conditions requiring treatment and close monitoring e.g. cardiac failure ≥ grade 4 (New York Heart Association), unstable coronary disease or oxygen dependent respiratory disease\n* A history of a proven hypercoagulable condition\n* Present, or history of, thrombotic thrombocytopenic purpura (TTP) or known familial history of TTP\n* Intake of investigational drugs (other than imlifidase) within 5 half-lives\n* Contemporaneous participation in a medical device study\n* Known allergy/sensitivity (except local reactions) to imlifidase or to any drug (or the excipients) specified in the protocol\n* Known mental incapacity or language barriers precluding adequate understanding of the Informed Consent information and the trial activities\n* Inability by the judgement of the investigator to participate in the trial for any other reason'}, 'identificationModule': {'nctId': 'NCT05049850', 'briefTitle': 'A Study to Investigate DSA Rebound in Patients Treated With Imlifidase Prior to Transplantation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hansa Biopharma AB'}, 'officialTitle': 'An Open Label, Phase II Study to Investigate DSA Rebound in Patients With a Positive Crossmatch, Made Transplantable With Imlifidase', 'orgStudyIdInfo': {'id': '18-HMedIdeS-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Imlifidase', 'description': 'Imlifidase is administered intravenously as one dose of 0.25 mg/kg over 15 minutes within the 24-hour period prior to transplantation. (A second dose may be given if the crossmatch test at 4 hours after the first dose remains positive.)', 'interventionNames': ['Drug: Imlifidase']}], 'interventions': [{'name': 'Imlifidase', 'type': 'DRUG', 'otherNames': ['IdeS, HMED-IdeS'], 'description': 'Imlifidase is an immunoglobulin G (IgG)-degrading enzyme of Streptococcus pyogenes that is highly specific for IgG.', 'armGroupLabels': ['Imlifidase']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Health Transplant Institute', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], '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'}}}}