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Impact of Microvascular Inflammation on Kidney Allograft Outcome

Impact of Microvascular Inflammation on Kidney Allograft Outcome: a Multinational Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06496269
Enrollment
6000
Registered
2024-07-11
Start date
2023-01-01
Completion date
2023-12-31
Last updated
2024-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplant Rejection, Transplant;Failure,Kidney

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.

Interventions

OTHERNo intervention

No intervention

Sponsors

Paris Translational Research Center for Organ Transplantation
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
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.

Design outcomes

Primary

MeasureTime frame
Microvascular inflammation-related diagnoses according to the Banff 2022 ClassificationMarch 2004 to December 2023
Kidney allograft lossMarch 2004 to December 2023

Secondary

MeasureTime frame
Transplant glomerulopathyMarch 2004 to December 2023
(Recurrent) antibody-mediated rejection episodeMarch 2004 to December 2023

Countries

France, Germany, Spain, Switzerland, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026