Non-invasive Blood Test to Diagnose Acute Rejection After Pancreas and Kidney Transplantation: Pancreas and Renal Rejection Diagnosis Using Circulating Donor-derived Cell-free DNA in Peripheral Blood
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 3
- 主要终点
- dd-cfDNA correlation to acute rejection
研究概览
简要总结
Donor-derived cell-free DNA (dd-cfDNA) has shown promise as an early marker for cellular injury caused by rejection. dd-cfDNA changes may also indicate other injuries that lead to progressive decline in transplant organ function associated with, in the case of kidney transplantation, the presence of interstitial fibrosis (IF) and tubular atrophy (TA) seen in biopsy specimens. Here, we will study the utility of dd-cfDNA to predict rejection in pancreas and pancreas-kidney recipients.
详细描述
+Objective The objective of this prospective observational study is to correlate circulating dd-cfDNA to clinical and sub-clinical acute rejection in pancreas transplant alone (PTA), pancreas after kidney (PAK), and simultaneous pancreas kidney (SPK) allograft recipients. The secondary objective study is to correlate circulating dd-cfDNA to pancreas and kidney function, using Hgb1c, C-peptide and insulin requirement to assess pancreas function, and using serum creatinine and estimated glomerular filtration rate (eGFR) to assess kidney function.
The clinical data and specimen collection will also enable future biomarker research.
+Study endpoints Serial dd-cfDNA in individuals over time will be correlated with clinical status and outcomes, such as events of allograft dysfunction or biopsy proven rejection.
The primary endpoints of the study are:
- Clinical T cell as well as antibody mediated acute rejection
- Sub-clinical T cell as well as antibody mediated acute rejection
- Composite of clinical and sub-clinical T cell as well as antibody mediated acute rejection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult recipients (Age > 18 years )
- •All genders and all racial and ethnic groups
- •Pancreas transplant alone (PTA)
- •Simultaneous kidney-pancreas transplantation (SPK)
- •Pancreas-after-kidney (PAK)
- •Simultaneous pancreas and living donor kidney (SPLK)
- •Primary or re-transplants
- •Ability to come for follow-up and undergo biopsy (Performed in accordance to SOC)
- •Provided consent
排除标准
- •Pediatric recipients (Age < 18 years)
- •Pregnant women
- •Patients undergoing multi-organ transplants not otherwise specified (e.g., pancreas-liver, multi-visceral, or pancreas-heart)
- •Patients receiving donor kidney from an identical twin, as part of an SPLK (see above)
- •Did not provide consent
结局指标
主要结局
dd-cfDNA correlation to acute rejection
时间窗: August 1, 2019 to July 31, 2022
To correlate circulating dd-cfDNA to clinical and sub-clinical acute rejection in PTA, PAK, and SPK allograft recipients. 1. Clinical T cell as well as antibody mediated acute rejection. 2. Sub-clinical T cell as well as antibody mediated acute rejection. 3. Composite of clinical and sub-clinical T cell as well as antibody mediated acute rejection.
次要结局
- dd-cfDNA correlation to pancreas and kidney function(August 1, 2019 to July 31, 2022)
研究者
Jonathan Bromberg
Principal Investigator
University of Maryland, Baltimore