Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT05246618
Status:
COMPLETED
Last Update Posted:
2024-06-04
First Post:
2021-11-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
FIH Phase I/IIa Trial Evaluating Safety of TUM012 to Minimize Ischemic Reperfusion Injury in Kidney Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-11-14', 'releaseDate': '2024-09-02'}, {'resetDate': '2025-04-22', 'releaseDate': '2025-04-03'}], 'estimatedResultsFirstSubmitDate': '2024-09-02'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015427', 'term': 'Reperfusion Injury'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-03', 'studyFirstSubmitDate': '2021-11-28', 'studyFirstSubmitQcDate': '2022-02-15', 'lastUpdatePostDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient survival', 'timeFrame': 'One year from randomization', 'description': 'Number'}, {'measure': 'Incidence of graft rejection', 'timeFrame': 'One year from randomization', 'description': 'Number'}, {'measure': 'Graft survival', 'timeFrame': 'One year from randomization', 'description': 'Number'}], 'primaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': 'Three months from randomization', 'description': 'Number of patients with confirmed IMP-related events'}, {'measure': 'Laboratory Analyses (Standard of Care Safety)', 'timeFrame': 'Three months from randomization', 'description': 'Assessment: "normal", "abnormal, not clinically significant", or "abnormal, clinically significant", will as appropriate be reported as Adverse Events.'}, {'measure': '12-lead Electro-Cardiogram (Standard of Care Safety)', 'timeFrame': 'Three months from randomization', 'description': 'Assessment: "normal", "abnormal, not clinically significant", or "abnormal, clinically significant"'}, {'measure': 'Systolic/diastolic BP (Standard of Care Safety)', 'timeFrame': 'Three months from randomization', 'description': 'Assessment: "normal", "abnormal, not clinically significant", or "abnormal clinically significant"'}, {'measure': 'Pulse Rate (Standard of Care Safety)', 'timeFrame': 'Three months from randomization', 'description': 'Assessment: "normal", "abnormal, not clinically significant", or "abnormal clinically significant"'}, {'measure': 'Peripheral blood oxygenation (Standard of Care Safety)', 'timeFrame': 'Three months from randomization', 'description': 'Assessment: "normal", "abnormal, not clinically significant", or "abnormal clinically significant"'}, {'measure': 'Body temperature (Standard of Care Safety)', 'timeFrame': 'Three months from randomization', 'description': 'Assessment: "normal", "abnormal, not clinically significant", or "abnormal clinically significant"'}], 'secondaryOutcomes': [{'measure': 'Exploratory histological evaluation of kidney graft', 'timeFrame': 'Three months from randomization', 'description': 'Biopsy'}, {'measure': 'Exploratory kidney graft function', 'timeFrame': 'Three months from randomization', 'description': 'Number'}, {'measure': 'Exploratory Efficacy: Proteomics', 'timeFrame': 'Three months from randomization', 'description': 'Changed levels from baseline.'}, {'measure': 'Exploratory Efficacy: Markers of IR injury and thromboinflammation plasma level', 'timeFrame': 'Three months from randomization', 'description': 'Changed levels from baseline.'}, {'measure': 'Exploratory Efficacy: Cytokine release plasma level', 'timeFrame': 'Three months from randomization', 'description': 'Changed levels from baseline.'}, {'measure': 'Exploratory Efficacy: Immune cell graft recruitment plasma level', 'timeFrame': 'Three months from randomization', 'description': 'Changed levels from baseline.'}, {'measure': 'Exploratory Efficacy: Pharmacokinetics plasma concentration', 'timeFrame': 'Three months from randomization', 'description': 'Changed levels from baseline.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ex-vivo kidney allograft treatment', 'Transplant outcome'], 'conditions': ['Ischemia-reperfusion Injury', 'Kidney Transplant; Complications']}, 'descriptionModule': {'briefSummary': 'A first-in-human single center, randomized, double-blind, placebo-controlled trial, with primary objective to evaluate safety and tolerability of ex-vivo kidney allograft treatment with TUM012 to reduce ischemia-reperfusion injury in de novo kidney transplant recipients.', 'detailedDescription': 'Graft ischemia and reperfusion related injury is still the leading cause of graft failure in Deceased Donor kidney transplantation. The aim of the trial is to evaluate the safety of ex-vivo treatment of kidney allografts from deceased-donors with TUM012 to diminish ischemia reperfusion related inflammation, and improve overall transplantat outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Standard and extended criteria donor ≥18 years of age, suitable for clinical transplantation and preserved by cold storage.\n* Available, personally signed and dated Informed Consent Form (ICF)\n* Male or female Chronic Kidney Disease (CKD) patient ≥18 years of age, with Glomerular Filtration Rate (GFR) ≤15 mL/min, awaiting their first kidney transplantation\n* ABO-compatible, negative pre-transplant CDC class I and II crossmatch with no Donor Specific Antibodies (DSA), defined as ≤1 000 Mean Fluorescent Intensity (MFI).\n* Patient is suitable for surgery, as judged by the investigator\n* Completed vaccination program for pneumococcal disease, varicella zoster, measles, and SARS-CoV-2 virus\n\nExclusion Criteria:\n\n* Surgically induced injuries compromising ex-vivo treatment and/or transplant outcome, as judged by the transplantation surgeon\n* Previously undergone any organ and/or cell transplantations\n* Patients with positive CDC class I and/or II crossmatch, or negative CDC class I and II crossmatch with pre-existing DSA \\> 1,000 MFI\n* ABO-incompatible DD KT\n* Pregnant or breast-feeding woman\n* Woman of child-bearing potential, unwilling to use an adequate contraceptive method\n* Prior participation in clinical trial with (approved or non-approved) IMP within one month prior to screening for this trial.\n* Prior malignancy diagnosis ≤5 years, except for adequately treated basal cell, or squamous cell skin cancer, and cervical carcinoma in situ\n* Positive result for serum Human Immunodeficiency Virus (HIV), active hepatitis B-, or C-infection in pre-transplant evaluation\n* Clinical signs of ongoing infectious disease, defined as C-Reactive Protein (CRP) \\>10, unless stable since \\>4 weeks (\\<50% increase)\n* Concomitant severe conditions requiring treatment and close monitoring, e.g., cardiac failure \\>grade 3 New York Heart Association (NYHA), unstable coronary disease, or oxygen dependent Chronic Obstructive Pulmonary Disease (COPD)\n* History of any other clinically significant disease or disorder which, in the opinion of the investigator, may either put the patient at increased risk because of participation in the trial, or influence the results or the patient's ability to participate in the trial\n* Patient unlikely to comply with trial procedures, restrictions, and requirements (e.g., caused by substance abuse, concurrent medical condition, etc.), as judged by investigator"}, 'identificationModule': {'nctId': 'NCT05246618', 'briefTitle': 'FIH Phase I/IIa Trial Evaluating Safety of TUM012 to Minimize Ischemic Reperfusion Injury in Kidney Transplantation', 'organization': {'class': 'INDUSTRY', 'fullName': 'iCoat Medical AB'}, 'officialTitle': 'Phase I FIH Phase I/IIa Randomized Placebocontrolled Doubleblind Trial Evaluating Safety and Tolerability of ExVivo Deceased Donor Kidney Allograft Treatment With TUM012 to Minimize Ischemic Reperfusion Injury After Kidney Transplantation', 'orgStudyIdInfo': {'id': 'ATMIRe'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TUM012', 'description': 'Ex-vivo infusion', 'interventionNames': ['Drug: TUM012']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Ex-vivo infusion', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'TUM012', 'type': 'DRUG', 'otherNames': ['Ex-vivo infusion'], 'description': 'Ex-vivo infusion', 'armGroupLabels': ['TUM012']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Ex-vivo infusion'], 'description': 'Ex-vivo infusion', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE-205 02', 'city': 'Malmo', 'country': 'Sweden', 'facility': 'Skane University Hospital', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}], 'overallOfficials': [{'name': 'Ingegerd Dalfelt', 'role': 'STUDY_DIRECTOR', 'affiliation': 'iCoat Medical AB'}]}, 'ipdSharingStatementModule': {'url': 'http://www.icoatmedical.com/', 'infoTypes': ['CSR'], 'timeFrame': 'After End of Trial', 'ipdSharing': 'YES', 'description': 'Individual participant data (IPD) collected in this study will be made available to participating trial patients through the investigational site and to the public through publications.', 'accessCriteria': 'Individual participant data (IPD) collected in this study will be made available to participating trial patients through the investigational site and to the public through publications, as well as on the company website.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'iCoat Medical AB', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'CTC Clinical Trial Consultants AB', 'class': 'INDUSTRY'}, {'name': 'Region Skane', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-09-02', 'type': 'RELEASE'}, {'date': '2024-11-14', 'type': 'RESET'}, {'date': '2025-04-03', 'type': 'RELEASE'}, {'date': '2025-04-22', 'type': 'RESET'}], 'unpostedResponsibleParty': 'iCoat Medical AB'}}}}