Skip to main content
OpenTrials
Completed

NCT Number: NCT06496269

Impact of Microvascular Inflammation on Kidney Allograft Outcome

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.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Bordeaux University Hospital, Department of Nephrology, Transplantation, Dialysis and Apheresis, Bordeaux, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Microvascular inflammation-related diagnoses according to the Banff 2022 Classification

    Time frame: March 2004 to December 2023

  2. Kidney allograft loss

    Time frame: March 2004 to December 2023

Secondary outcomes

  1. Transplant glomerulopathy

    Time frame: March 2004 to December 2023

  2. (Recurrent) antibody-mediated rejection episode

    Time frame: March 2004 to December 2023

Sponsors and collaborators

Lead sponsor

Paris Translational Research Center for Organ Transplantation

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 11, 2024
Registry last updated
Jul 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.