Impact of Microvascular Inflammation on Kidney Allograft Outcome
- Conditions
- Kidney Transplant RejectionTransplant;Failure,Kidney
- Registration Number
- NCT06496269
- Lead Sponsor
- Paris Translational Research Center for Organ Transplantation
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6000
- Kidney transplant recipients, with at least one kidney transplant biopsy performed, assessed with the Banff classification.
- Missing data for a rejection-related diagnosis according to the 2019 and 2022 Banff classification.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Microvascular inflammation-related diagnoses according to the Banff 2022 Classification March 2004 to December 2023 Kidney allograft loss March 2004 to December 2023
- Secondary Outcome Measures
Name Time Method (Recurrent) antibody-mediated rejection episode March 2004 to December 2023 Transplant glomerulopathy March 2004 to December 2023
Trial Locations
- Locations (19)
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
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