A Pilot Study of OmniGraft in Simultaneous Pancreas Kidney Recipients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Number of participants that underwent SPK transplant
研究概览
简要总结
The purpose of this research is learn about how OmniGraf works in kidney pancreas transplant patients. Also, to analyze the performance characteristics of OmniGrafTM (TruGraf Gene Expression Profiling (GEP) and T Cell Receptor Alpha Constant (TRAC) dd-cfDNA) in a population of simultaneous kidney pancreas transplants as a part of routine surveillance, as well as a part of the workup for patients clinically suspected to have rejection of the kidney and/or pancreas.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female adult (≥18 years old) with a history of simultaneous pancreas kidney transplant between 3 months and 1 year prior to enrollment (cohort 1) or at the time of presentation for "for-cause" biopsy
- •Adults able to consent
- •Bladder or enteric drained
- •Type 1 or Type 2 DM
排除标准
- •Recipient of an organ transplant other than a simultaneous pancreas kidney transplant
- •Known to be pregnant
- •Known to be infected with Human Immunodeficiency Virus with actively replicating HIV virus
- •Active BK viremia with >100,000 copies or biopsy proven BK nephropathy
- •Participation in other biomarker studies
- •Pancreas transplant alone
- •Re-transplantation, unless both organs have been removed prior to or at the time of the retransplant procedure.
结局指标
主要结局
Number of participants that underwent SPK transplant
时间窗: Up to 3 years
Number of participants that underwent SPK transplant measured by Omnigraft testing. The Omnigraft test includes TruGraf GEP and TRAC dd-cfDNA.
次要结局
未报告次要终点
研究者
Mariella Ortigosa Goggins
Associate Professor of Clinical
University of Miami