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Impact of Microvascular Inflammation on Kidney Allograft Outcome

Completed
Conditions
Kidney Transplant Rejection
Transplant;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
Inclusion Criteria
  • Kidney transplant recipients, with at least one kidney transplant biopsy performed, assessed with the Banff classification.
Exclusion Criteria
  • 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
NameTimeMethod
Microvascular inflammation-related diagnoses according to the Banff 2022 ClassificationMarch 2004 to December 2023
Kidney allograft lossMarch 2004 to December 2023
Secondary Outcome Measures
NameTimeMethod
(Recurrent) antibody-mediated rejection episodeMarch 2004 to December 2023
Transplant glomerulopathyMarch 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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Pediatric Nephrology, UCLA Mattel Children's Hospital
🇺🇸Los Angeles, California, United States

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