Ignite Creation Date:
2025-12-24 @ 11:11 PM
Ignite Modification Date:
2025-12-28 @ 7:59 AM
Study NCT ID:
NCT06496269
Status:
COMPLETED
Last Update Posted:
2024-07-11
First Post:
2024-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Microvascular Inflammation on Kidney Allograft Outcome
Sponsor:
Paris Translational Research Center for Organ Transplantation
Organization:
Study Overview
Official Title:
Impact of Microvascular Inflammation on Kidney Allograft Outcome: a Multinational Cohort Study
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: