Immunosuppression Reduction in Failed Allograft Guided by cfDNA
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- cPRA Concentrations
研究概览
简要总结
The optimal timing for immunosuppression tapering for patients with failed kidney transplant is not known. This pilot study would be to correlate rise in cf-DNA and increase in cPRA.
详细描述
This is an observational cohort study collecting data and blood specimens at designated time points. The primary outcome will be comparing the cPRA in patients that have a rise in cf-DNA to those that do not have a rise in cf-DNA. Seondary outcomes include comparison of the combined incidence of need for transfusion, need for methylprednisolone and allograft nephrectomy, ESA dose, allograft tenderness, and gross hematuria.
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
- •Failed allograft requiring dialysis
- •No living donor available for re-transplant option or anticipated deceased donor within the next 12 months
- •Patient to be enrolled prior to 3rd HD (hemodialysis) session or within 1 week of starting peritoneal dialysis
排除标准
- •17 years or younger
- •cPRA at entrance of 100%
- •Primary non-function of the allograft
- •Multi-organ transplant
结局指标
主要结局
cPRA Concentrations
时间窗: 1 day
Outcome is reported as the serum concentration of calculated Panel Reactive Antibody (cPRA) at baseline.
cf-DNA Concentrations
时间窗: up to 24 weeks
Outcome is reported as the serum concentration of circulating-free DNA (cfDNA) at baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, and 24 weeks.
次要结局
- Incidence of Need for Transfusion(24 weeks)
- Incidence of Need for Methylprednisolone and Allograft Nephrectomy(24 weeks)
- Incidence of Allograft Tenderness(24 weeks)
- Incidence of Gross Hematuria(24 weeks)
- Incidence of ESA Dose(24 weeks)