Urine CXCL10 Chemokine Monitoring Post-renal Transplant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 241
- 试验地点
- 1
- 主要终点
- Subclinical T-cell mediated rejection in 1-year surveillance biopsy defined by t>0 and/or v>0
研究概览
简要总结
In this study investigators will investigate whether early treatment of allograft rejection, as detected by urine CXCL10-monitoring, improves outcomes in renal allograft recipients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
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
- •All consenting adult (age>=18) renal allograft recipients
排除标准
- •Human Leucocyte Antigen (HLA) -identical living donor transplantation
- •Primary non-function
- •Participation in immunosuppression interventional trials
研究组 & 干预措施
Intervention
Urine CXCL10-chemokine levels will be monitored at specific time points post-transplant. Sustained elevated levels will trigger performance of a renal allograft biopsy. Any rejection will be treated. Rejection treatment according to clinical standard-of-care
干预措施: Rejection treatment according to clinical standard-of-care (Drug)
结局指标
主要结局
Subclinical T-cell mediated rejection in 1-year surveillance biopsy defined by t>0 and/or v>0
时间窗: First year post-transplant
1-year composite outcome consisting of at least one of the primary outcomes 1 to 4
Interstitial fibrosis / tubular atrophy with inflammation (IFTA+i defined by the Mayo Clinic criteria) in 1-year surveillance biopsy
时间窗: First year post-transplant
1-year composite outcome consisting of at least one of the primary outcomes 1 to 4
Graft loss not due to death of the patient
时间窗: First year post-transplant
1-year composite outcome consisting of at least one of the primary outcomes 1 to 4
Biopsy-proven clinical acute rejection
时间窗: 4-weeks up to 1-year post-transplant
1-year composite outcome consisting of at least one of the primary outcomes 1 to 4
次要结局
- Proteinuria(yearly up to 10 years)
- Graft and its cause(yearly up to 10 years)
- Biopsy-proven rejection(yearly up to 10 years)
- Safety assessed by biopsy-related complications within the first year post-transplant(First year post-transplant)
- Efficacy assessed by development of IFTA from implantation to 1-year (∆ ci, ct, cv)(First year post-transplant)
- Efficacy assessed by microvascular inflammation at 1-year (ptc, g, c4d, cg)(First year post-transplant)
- Efficacy assessed by Proteinuria >500mg/day at 6- and 12-months post-transplant(First year post-transplant)
- Safety assessed by total number of biopsies, indication for biopsy and CXCL10-triggered biopsies within the first year post-transplant(First year post-transplant)
- Safety assessed by immunosuppression-related complications as infections and cancer within the first year post-transplant(First year post-transplant)
- Allograft function measured by creatinine and eGFR(yearly up to 10 years)
- Efficacy assessed by number of days from transplantation to biopsy-proven clinical acute rejection(First year post-transplant)
- Death and its cause(yearly up to 10 years)