Transplantation of HCV Donor Kidneys in HCV Negative or Previously Successfully Treated Recipients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- 1-year graft and patient survival
研究概览
简要总结
To determine the efficacy and safety of transplanting HCV positive kidney allografts to HCV sero-negative patients who are on the waiting list.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Male or female
- •Age 18 and older
- •English and Spanish speaking patients
- •Active on the waiting list for kidney transplantation
- •Donor organ with Antibody and NAT (nucleic acid test) positive for HCV
- •HCV negative recipient; this includes patients who never had HCV and those with HCV previously eradicated with antiviral therapy. The latter is defined as those with undetectable HCV viral load at least 3 months since stopping therapy.
- •Willing and able to provide written informed consent
排除标准
- •Participants co-infected with HIV
- •Donor previously treated with an NS5a containing regimen (if treatment history of donor known)
- •Known allergies or hypersensitivity to DAA or RBV
- •Pregnancy and/or actively breastfeeding
研究组 & 干预措施
Recipient of HCV positive kidney graft
A single center, open-label, pilot study examining 20 adult HCV negative kidney transplant patients who receive an HCV infected graft. Target start date for antiviral therapy will be within 3 months after kidney transplantation, unless extenuating clinical circumstances arise (such as the development of fibrosing cholestatic HCV, which would prompt earlier treatment, or clinical events or comorbidities which would prompt delay in treatment).
干预措施: Kidney Transplantation (Procedure)
结局指标
主要结局
1-year graft and patient survival
时间窗: From the date of transplant through the last day of 12 month post transplant
Will track subjects post transplant for 12 months
次要结局
未报告次要终点