Impact of Microvascular Inflammation on Kidney Allograft Outcome: a Multinational Cohort Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 6,000
- Locations
- 19
- Primary Endpoint
- Microvascular inflammation-related diagnoses according to the Banff 2022 Classification
Study Overview
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:
- 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.
- To assess the association of microvascular inflammation phenotypes with kidney allograft survival.
- To assess the association of microvascular inflammation phenotypes with disease progression, defined by transplant glomerulopathy occurrence (cg and subsequent antibody-mediated rejection episodes.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Microvascular inflammation-related diagnoses according to the Banff 2022 Classification
Time Frame: March 2004 to December 2023
Kidney allograft loss
Time Frame: March 2004 to December 2023
Secondary Outcomes
- Transplant glomerulopathy(March 2004 to December 2023)
- (Recurrent) antibody-mediated rejection episode(March 2004 to December 2023)