Ignite Creation Date:
2025-12-24 @ 11:11 PM
Ignite Modification Date:
2026-03-09 @ 9:20 PM
Study NCT ID:
NCT06496269
Status:
COMPLETED
Last Update Posted:
2024-07-11
First Post:
2024-07-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Microvascular Inflammation on Kidney Allograft Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-03', 'studyFirstSubmitDate': '2024-07-03', 'studyFirstSubmitQcDate': '2024-07-03', 'lastUpdatePostDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Microvascular inflammation-related diagnoses according to the Banff 2022 Classification', 'timeFrame': 'March 2004 to December 2023'}, {'measure': 'Kidney allograft loss', 'timeFrame': 'March 2004 to December 2023'}], 'secondaryOutcomes': [{'measure': 'Transplant glomerulopathy', 'timeFrame': 'March 2004 to December 2023'}, {'measure': '(Recurrent) antibody-mediated rejection episode', 'timeFrame': 'March 2004 to December 2023'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Transplant;Failure,Kidney', 'Kidney Transplant Rejection']}, 'referencesModule': {'references': [{'pmid': '39450752', 'type': 'DERIVED', 'citation': 'Sablik M, Sannier A, Raynaud M, Goutaudier V, Divard G, Astor BC, Weng P, Smith J, Garro R, Warady BA, Zahr RS, Twombley K, Dharnidharka VR, Dandamudi RS, Fila M, Huang E, Sellier-Leclerc AL, Tonshoff B, Rabant M, Verine J, Del Bello A, Berney T, Boyer O, Catar RA, Danger R, Giral M, Yoo D, Girardin FR, Alsadi A, Gourraud PA, Morelon E, Le Quintrec M, Try M, Villard J, Zhong W, Bestard O, Budde K, Chauveau B, Couzi L, Brouard S, Hogan J, Legendre C, Anglicheau D, Aubert O, Kamar N, Lefaucheur C, Loupy A. Microvascular Inflammation of Kidney Allografts and Clinical Outcomes. N Engl J Med. 2025 Feb 20;392(8):763-776. doi: 10.1056/NEJMoa2408835. Epub 2024 Oct 24.'}]}, 'descriptionModule': {'briefSummary': 'Graft microvascular inflammation poses a significant challenge to successful kidney transplantation due to its heterogeneous clinical presentation. There is a critical need to unravel the clinical significance of newly defined allograft microvascular inflammation phenotypes in the Banff 2022 classification and assess the implications of these new phenotypes on kidney transplant precision diagnostics and patient risk stratification.', 'detailedDescription': 'Antibody-mediated rejection is a major cause of graft failure in kidney transplant recipients, with allograft microvascular inflammation serving as the hallmark histological lesion of antibody-mediated graft injury. However, the frequent occurrence of graft microvascular inflammation in the absence of circulating anti-HLA donor-specific antibodies highlights the incomplete understanding of the mechanisms underlying this inflammation. This heterogenous presentation poses a significant challenge in the clinical setting, as current treatment strategies often prove ineffective, hindering the improvement of allograft and patient care. The Banff 2022 classification update has reappraised lesions of microvascular inflammation, identifying new diagnostic phenotypes of microvascular inflammation. However, the clinical significance of these phenotypes is yet to be determined.\n\nThe aims of this study are:\n\n1. To determine the impact of the revised Banff 2022 Classification on the diagnostic classification of phenotypes related to microvascular inflammation, compared to previous Banff 2019 Classification.\n2. To assess the association of microvascular inflammation phenotypes with kidney allograft survival.\n3. To assess the association of microvascular inflammation phenotypes with disease progression, defined by transplant glomerulopathy occurrence (cg and subsequent antibody-mediated rejection episodes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Kidney transplant recipients of all sexes recruited in observational studies performed in Europe and United States, with at least one kidney biopsy performed with all the relevant data to provide a diagnosis according to the 2019 and 2022 Banff classification, including clinical data (recipient and donor's age, sex and transplant characteristics).", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Kidney transplant recipients, with at least one kidney transplant biopsy performed, assessed with the Banff classification.\n\nExclusion Criteria:\n\n* Missing data for a rejection-related diagnosis according to the 2019 and 2022 Banff classification.'}, 'identificationModule': {'nctId': 'NCT06496269', 'briefTitle': 'Impact of Microvascular Inflammation on Kidney Allograft Outcome', 'organization': {'class': 'OTHER', 'fullName': 'Paris Translational Research Center for Organ Transplantation'}, 'officialTitle': 'Impact of Microvascular Inflammation on Kidney Allograft Outcome: a Multinational Cohort Study', 'orgStudyIdInfo': {'id': 'MVI_Kidney_002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Pediatric Nephrology, UCLA Mattel Children's Hospital", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '30329', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Division of Pediatric Nephrology, Children's Pediatric Institute", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Division of Pediatric Nephrology, Children's Mercy Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Acute Dialysis Units, Pediatric Kidney Transplant', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '38103', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': "Division of Pediatric Nephrology and Hypertension, Le Bonheur Children's Hospital", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Department of Pediatrics, Seattle Children's Hospital", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Division of Nephrology, Department of Medicine, University of Wisconsin School of Medicine and Public Health', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'city': 'Bordeaux', 'country': 'France', 'facility': 'Bordeaux University Hospital, Department of Nephrology, Transplantation, Dialysis and Apheresis', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Department of Transplantation, Nephrology and Clinical Immunology, Hospices Civils de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Montpellier', 'country': 'France', 'facility': 'Department of Nephrology, Centre Hospitalier Universitaire de Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Nantes', 'country': 'France', 'facility': 'Nantes University Hospital, Department of Nephrology', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Paris', 'country': 'France', 'facility': 'Division of Pediatric Nephrology, Necker Hospital, AP-HP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'Division of Pediatric Nephrology, Robert Debré Hospital, AP-HP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'Kidney Transplant Department, Necker Hospital, Assistance Publique - Hôpitaux de Paris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'Kidney Transplant Department, Saint-Louis Hospital, Assistance Publique - Hôpitaux de Paris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'Department of Nephrology-Dialysis-Transplantation, Centre Hospitalier Universitaire de Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Department of Nephrology and Critical Care Medicine, Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Berlin Institute of Health', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': "Department of Nephrology and Kidney Transplantation, Vall d'Hebrón University Hospital", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Division of Abdominal and Transplantation Surgery, Department of Surgery, Geneva University Hospitals,', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'overallOfficials': [{'name': 'Alexandre Loupy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Paris Institute for Transplantation and Organ Regeneration'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The data analyzed during the current study are available on reasonable request including standards for General Data Protection Regulation and Institutional Review Board approval.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Paris Translational Research Center for Organ Transplantation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}