Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2026-01-12 @ 12:28 PM
Study NCT ID:
NCT05430620
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2022-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intermittent Versus Continuous Surface O2 During HMP of DCD Kidneys
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051799', 'term': 'Delayed Graft Function'}, {'id': 'D015427', 'term': 'Reperfusion Injury'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010100', 'term': 'Oxygen'}], 'ancestors': [{'id': 'D018011', 'term': 'Chalcogens'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005740', 'term': 'Gases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Kidneys originating from deceased donors after circulatory death (DCD), category 3 and 5 (controlled) will be preserved from procurement until transplantation on hypothermic machine perfusion conditions and prospectively randomized into 2 study groups: 1) intermittent surface oxygenation during HMP (surface oxygenation interrupted during organ transport (2-4h)(I-HMPO2 group), and 2) continuous surface oxygenation during HMP (surface oxygenation during the whole machine preservation period included organ transport)(C-HMPO2 group)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-22', 'studyFirstSubmitDate': '2022-06-17', 'studyFirstSubmitQcDate': '2022-06-23', 'lastUpdatePostDateStruct': {'date': '2024-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional delayed graft function', 'timeFrame': 'first 7 days after transplantation', 'description': 'defined as the absence of a decrease in the serum creatinine level of at least 10% per day for at least 3 consecutive days in the first 7 days after transplantation (not including patients in whom acute rejection of calcineurin inhibitor toxicity is proven on biopsy)'}], 'secondaryOutcomes': [{'measure': 'Need for dialysis after transplantation', 'timeFrame': '0-30 days after transplantation', 'description': 'Number of dialysis sessions after transplantation'}, {'measure': 'Delayed graft function', 'timeFrame': 'first 7 days after transplantation', 'description': 'defined as the need for dialysis in the first 7 days after transplantation and preceding the return of kidney function'}, {'measure': 'Serum creatinine reduction ratio', 'timeFrame': 'Day 1-2 after transplantation', 'description': 'alternative definition of DGF= CRR2 \\< or = 30%'}, {'measure': 'Graft survival', 'timeFrame': 'From 1-365 days after transplantation', 'description': 'Functional kidney graft at 7 days, 3, 6, and 12 months'}, {'measure': 'Patient survival (censored and uncensored for death)', 'timeFrame': 'From 1-365 days after transplantation', 'description': 'Patient survival at 7 days, 3, 6, and 12 months'}, {'measure': 'Glomerular filtration rate at 1 year after transplantation', 'timeFrame': 'At 1 year after transplantation (window 30 days)', 'description': '24-hour creatinine clearance'}, {'measure': 'Estimated glomerular filtration rate', 'timeFrame': 'At 3, 6, and 12 months after transplantation with window of 10 days', 'description': 'eGFR defined by the CKD-EPI equation (Chronic Kidney Disease Epidemiology Collaboration) at 3, 6 and 12 months after transplantation'}, {'measure': 'Primary non-function', 'timeFrame': 'Until 3 months after transplantation', 'description': 'defined as the continued need for dialysis at 3 months after transplantation'}, {'measure': 'Biopsy-proven acute rejection', 'timeFrame': 'Until 1 year after transplantation with window of 10 days', 'description': 'Biopsy-proven acute rejection during the 1 year after transplantation'}, {'measure': 'Metabolic analysis on kidney preservation tissue', 'timeFrame': 'Baseline and pre-surgery', 'description': 'Metabolic analysis by 1D proton NMR (e.g., succinate, lactate, acetate, formate, hypoxanthine) on a tissue sample taken before (= baseline) and at the end of the preservation period before transplantation of the kidney'}, {'measure': 'Metabolic analysis on kidney preservation tissue', 'timeFrame': 'Baseline and pre-surgery', 'description': 'Metabolic analysis by liquid chromatography coupled to electrospray ionization mass spectrometry (LC-ESI-MS) (succinate, glutamate, lactate, ATP, ADP, AMP, NADH, NAD+) on a tissue sample taken before (= baseline) and at the end of the preservation period before transplantation of the kidney'}, {'measure': 'Metabolic analysis on preservation fluid', 'timeFrame': 'Baseline and pre-surgery', 'description': 'Metabolic analysis by 1D proton NMR and fluorescence on a perfusion fluid sample taken before (= baseline) and at the end of the preservation period before transplantation of the kidney'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypothermic oxygenated machine perfusion', 'Kidney preservation', 'bubble and surface oxygenation'], 'conditions': ['Delayed Graft Function', 'Kidney Transplant; Complications', 'Ischemia Reperfusion Injury', 'Mitochondrial']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate the feasibility of this bubble and surface oxygenation and to determine the optimal timing of surface oxygenation (continuous versus intermittent) as alternative for membrane-oxygenated kidneys, originating from DCD donors, during HMP on early graft function in clinical practice.', 'detailedDescription': 'Kidneys originating from deceased donors after circulatory death (DCD), category 3 and 5 (controlled) will be preserved from procurement until transplantation on hypothermic machine perfusion conditions and prospectively randomized into 2 study groups: 1) intermittent surface oxygenation during HMP (surface oxygenation interrupted during organ transport (2-4h)(I-HMPO2 group), and 2) continuous surface oxygenation during HMP (surface oxygenation during the whole machine preservation period included organ transport)(C-HMPO2 group).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Listed for a renal transplantation due to end stage renal disease\n* Willingness to comply with the protocol procedures for the duration of the study included scheduled follow-up visits and examinations.\n\nExclusion Criteria:\n\n* Multi-organ recipients\n* Dual kidney transplantation'}, 'identificationModule': {'nctId': 'NCT05430620', 'acronym': 'HMPO2', 'briefTitle': 'Intermittent Versus Continuous Surface O2 During HMP of DCD Kidneys', 'organization': {'class': 'OTHER', 'fullName': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}, 'officialTitle': 'A Prospective Feasibility Trail to Compare the Efficacy of Intermittent Surface Oxygenation With Continuous Surface Oxygenation During Hypothermic Machine Perfusion of Kidneys Donated After Circulatory Death', 'orgStudyIdInfo': {'id': '2021/21MAI/239'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'I-HMPO2', 'description': 'intermittent surface oxygenation during hypothermic machine perfusion (surface oxygenation interrupted during organ transport)', 'interventionNames': ['Drug: Oxygen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'C-HMPO2', 'description': 'continuous surface oxygenation during HMP (surface oxygenation during the whole machine preservation period included organ transport)', 'interventionNames': ['Drug: Oxygen']}], 'interventions': [{'name': 'Oxygen', 'type': 'DRUG', 'otherNames': ['feasibility of bubble and surface oxygenation applied to the LifePort Kidney Transporter (Organ Recovery Systems, Diegem, Belgium)'], 'description': 'Active oxygenation during hypothermic machine perfusion by bubble and surface oxygenation. Intermittent surface oxygenation is compared with continuous surface oxygenation during hypothermic machine perfusion', 'armGroupLabels': ['C-HMPO2', 'I-HMPO2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Brussels', 'state': 'Woluwé-Saint-Lambert', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Tom Darius, MD, PhD', 'role': 'CONTACT', 'email': 'tom.darius@saintluc.uclouvain.be', 'phone': '+3227646065'}, {'name': 'Nathalie Staumont', 'role': 'CONTACT', 'email': 'nathalie.staumont@saintluc.uclouvain.be', 'phone': '+3227642218'}], 'facility': 'Cliniques Universitaires Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'centralContacts': [{'name': 'Tom Darius, Phd', 'role': 'CONTACT', 'email': 'tom.darius@saintluc.uclouvain.be', 'phone': '003227642218'}, {'name': 'Nathalie Staumont', 'role': 'CONTACT', 'email': 'nathalie.Staumont@saintluc.uclouvain.be', 'phone': '003227642218'}], 'overallOfficials': [{'name': 'Tom Darius, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}