Evaluating Urinary CXCL10 for Enhanced Detection of Acute Rejection in Kidney Transplant Patients With Low DD-CFDNA: Diagnostic Performance and Transport Stability Across Shipping Conditions (CLEAR-CXCL10)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Assess urinary CXCL10 compared to dd-cfDNA for diagnosing acute rejection in kidney transplant recipients
研究概览
简要总结
Kidney transplant rejection remains a significant challenge to long-term graft survival. While histological biopsy continues to be the gold standard for diagnosing rejection, noninvasive biomarkers such as donor-derived cell-free DNA (dd-cfDNA) have gained traction for their ability to detect allograft injury. However, dd-cfDNA may lack sensitivity in certain clinical scenarios particularly in cases of localized immune activation leading to false negatives despite biopsy-confirmed rejection.
详细描述
One promising biomarker is CXCL10 (C-X-C motif chemokine ligand 10), a chemokine induced by interferon-γ that plays a central role in recruiting CXCR3+ T cells during immune responses. A 2021 study by Arnau et al. found that urinary CXCL10 levels were significantly associated with Banff scores of acute graft injury and donor-specific antibodies, and could discriminate both T-cell-mediated and antibody-mediated rejection in kidney transplant recipients, identifying CXCL10 as a promising candidate non-invasive biomarker for monitoring allograft rejection.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prospective Inclusion Criteria:
- •Age ≥18 years
- •Undergoing a clinically indicated biopsy
- •Able to provide informed consent
- •Willing to provide a urine sample and allow access to relevant clinical
- •Retrospective Inclusion Criteria:
- •Age ≥18 years
- •Biopsy-confirmed rejection (positive histology)
- •Donor-derived cell-free DNA<1% result at time of biopsy
- •Availability of stored urine sample collected at time of biopsy
排除标准
- •(applies to both arms):
- •Individuals under 18 years of age
- •Individuals unable to provide informed consent (for prospective enrollment)
- •Pregnant women
- •Prisoners
- •Adults unable to consent
研究组 & 干预措施
Prospective (Kidney Transplant recipients)
There will be 30 Prospective (Kidney Transplant recipients) subjects enrolled
干预措施: Prospective Cohort Enrollment (Other)
Retrospective (Kidney Transplant recipients)
There will be 20 Retrospective (Kidney Transplant recipients) subjects enrolled
干预措施: Retrospective Cohort Enrollment (Other)
结局指标
主要结局
Assess urinary CXCL10 compared to dd-cfDNA for diagnosing acute rejection in kidney transplant recipients
时间窗: From date of inclusion until loss of follow-up, graft loss or death assessed up to 5 years.
Assess whether urinary CXCL10 concentration (pg/mL) demonstrates improved sensitivity compared to donor-derived cell-free DNA (dd-cfDNA) for diagnosing acute rejection in kidney transplant recipients, specifically among discordant cases with biopsy-confirmed rejection and dd-cfDNA levels below 1%. Urine sample collected prospectively, during clinically indicated biopsy visit. Urine sample collected retrospectively, during clinically indicated retrospective biopsy visit.
Assess the stability of urinary CXCL10 under different transport conditions
时间窗: From date of inclusion until loss of follow-up, graft loss or death assessed up to 5 years.
Assess the stability of urinary CXCL10 (percent recovery) under different transport conditions-refrigerated, and ambient (room temperature)-to determine whether ambient shipping is a viable alternative to cold-chain transport for clinical testing. Urine sample collected prospectively, during clinically indicated biopsy visit. Urine sample collected retrospectively, during clinically indicated retrospective biopsy visit.
次要结局
- Compare urinary CXCL10 concentrations to assess potential degradation or variability.(From date of inclusion until loss of follow-up, graft loss or death assessed up to 5 years.)
- Determine whether ambient shipping (urine sample) affects the clinical reliability of CXCL10 measurements(From date of inclusion until loss of follow-up, graft loss or death assessed up to 5 years.)
- Assess the feasibility of implementing ambient (urine sample) shipping as a cost-effective alternative(From date of inclusion until loss of follow-up, graft loss or death assessed up to 5 years.)