Loading clinical trials...
Loading clinical trials...
Impact of Microvascular Inflammation on Kidney Allograft Outcome: a Multinational Cohort Study
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.
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. The aims of this study are: 1. 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. 2. To assess the association of microvascular inflammation phenotypes with kidney allograft survival. 3. To assess the association of microvascular inflammation phenotypes with disease progression, defined by transplant glomerulopathy occurrence (cg and subsequent antibody-mediated rejection episodes.
Age
All ages
Sex
ALL
Healthy Volunteers
No
Pediatric Nephrology, UCLA Mattel Children's Hospital
Los Angeles, California, United States
Division of Pediatric Nephrology, Children's Pediatric Institute
Atlanta, Georgia, United States
Division of Pediatric Nephrology, Children's Mercy Hospital
Kansas City, Missouri, United States
Acute Dialysis Units, Pediatric Kidney Transplant
Charleston, South Carolina, United States
Division of Pediatric Nephrology and Hypertension, Le Bonheur Children's Hospital
Memphis, Tennessee, United States
Department of Pediatrics, Seattle Children's Hospital
Seattle, Washington, United States
Division of Nephrology, Department of Medicine, University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States
Bordeaux University Hospital, Department of Nephrology, Transplantation, Dialysis and Apheresis
Bordeaux, France
Department of Transplantation, Nephrology and Clinical Immunology, Hospices Civils de Lyon
Lyon, France
Department of Nephrology, Centre Hospitalier Universitaire de Montpellier
Montpellier, France
Start Date
January 1, 2023
Primary Completion Date
December 31, 2023
Completion Date
December 31, 2023
Last Updated
July 11, 2024
6,000
ACTUAL participants
No intervention
OTHER
Lead Sponsor
Paris Translational Research Center for Organ Transplantation
NCT07006532
NCT04736381
NCT04702022
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions