Impact of Microvascular Inflammation on Kidney Allograft Outcome: a Multinational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6,000
- 试验地点
- 19
- 主要终点
- Microvascular inflammation-related diagnoses according to the Banff 2022 Classification
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Kidney transplant recipients, with at least one kidney transplant biopsy performed, assessed with the Banff classification.
排除标准
- •Missing data for a rejection-related diagnosis according to the 2019 and 2022 Banff classification.
结局指标
主要结局
Microvascular inflammation-related diagnoses according to the Banff 2022 Classification
时间窗: March 2004 to December 2023
Kidney allograft loss
时间窗: March 2004 to December 2023
次要结局
- Transplant glomerulopathy(March 2004 to December 2023)
- (Recurrent) antibody-mediated rejection episode(March 2004 to December 2023)