Long Term Surveillance of Islet Transplant Recipients Following Complete Graft Loss
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- determine the rate of allosensitization in patients after failed islet transplantation
研究概览
简要总结
This is a single-center, prospective, open label study in islet transplant recipients following islet graft loss.
详细描述
After complete islet graft loss is determined, patient's maintenance immunosuppression (i.e. sirolimus, tacrolimus, MMF and/or Myfortic®) will be discontinued and they will be monitored for 10 years thereafter, for the appearance of allosensitization using panel reactive antibody (PRA) levels and monitor the persistence of elevated PRA levels. Primary objective is to determine the rate of allosensitization in patients 3 years after failed islet transplantation (i.e. stimulated c-peptide <0.3mg/mL) and monitor the persistence of elevated PRA levels (≥ 20%) at year 3, 6, and 9. Timing, frequency and level of change in PRA will be monitored after all immunosuppression is discontinued.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •1. History of at least one islet alone transplant (ie islet transplant in the absence of any other organ transplant).
排除标准
- •Inability to provide written informed consent.
- •Mentally unstable and/or unable to comply with the procedures of the study protocol.
- •History of any solid organ transplant.
结局指标
主要结局
determine the rate of allosensitization in patients after failed islet transplantation
时间窗: 10 years
次要结局
未报告次要终点
研究者
Rodolfo Alejandro
Professor of Medicine
University of Miami