A Trial of Transplanting Hepatitis C Kidneys Into Hepatitis C-Negative Kidney Recipients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 22
- 主要终点
- Post-treatment sustained virologic response (SVR) to direct-acting antiviral (DAA)
研究概览
简要总结
The Transplanting Hepatitis C Kidneys into Negative KidnEy Recipients [THINKER-NEXT] study will include adult kidney transplant candidates without hepatitis C virus (HCV) infection on the transplant waiting list who will consent to kidney transplantation from a deceased donor infected with HCV, followed by treatment with a direct acting antiviral. The one-year allograft function and one-year risk of CMV infection will be compared between THINKER-NEXT kidney transplant recipients and matched recipients who received hepatitis C uninfected kidney transplants (these patients are called Transplant Cohort). The survival rate of patients opting-in for offers of kidneys from HCV-viremic donors will be compared to the survival rate of matched comparators from the kidney transplant waitlist who did not consent to receive offers of a HCV-viremic kidney. Lastly, renal pathologic findings will be compared among HCV-viremic donors and HCV-negative comparator donors.
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
- •Able to provide informed consent
- •Active waiting list status for isolated kidney transplant
- •18 years of age or older
- •No living kidney donor
- •Panel reactive antibody (PRA) ≤97% (most recent cPRA at time of screening). Patients with a PRA of 98-100% at screening can be included unless patient has a most recent cytotoxic PRA of >25% or calculated PRA >50% where multiple moderate level HLA antibodies exist and in the opinion of the local site investigator represents substantial HLA sensitization. If patient has a PRA of 98-100%, the donor-recipient pair must meet additional eligibility criteria.
排除标准
- •Hepatocellular carcinoma
- •Hepatitis B surface antigen and/or DNA positive
- •Active Hepatitis C infection
- •HIV RNA-positive or HIV antibody positive
- •Other chronic liver disease (excluding non-alcoholic fatty liver disease [NAFLD] with normal liver enzymes)
- •Persistently elevated liver transaminases (defined as the upper limit of normal at the reference laboratory)
- •Advanced hepatic fibrosis or cirrhosis
- •Primary Focal Segmental Glomerulosclerosis (FSGS), FSGS recurring in initial transplant, or other disease process at high risk of early graft failure per the treating transplant nephrologist
- •Current use of amiodarone or dronedarone (due to interaction with sofosbuvir)
- •Transplant candidate requires antibody desensitization protocol for transplantation
- •Female who is pregnant, planning to become pregnant during the study, or breast-feeding
- •Participation in another interventional study, from a period starting 6 months prior to screening to last study visit, that the study PIs judge would interfere with either the aims or the safety of the THINKER-NEXT study.
研究组 & 干预措施
Epclusa (sofosbuvir/velpatasvir)
Epclusa is taken by mouth for 12 weeks as per the FDA label.
干预措施: Epclusa (Drug)
结局指标
主要结局
Post-treatment sustained virologic response (SVR) to direct-acting antiviral (DAA)
时间窗: Baseline to 24 weeks
The primary analysis will be based on a calculation of SVR rates (number of subjects with SVR-12; negative HCV RNA 12 weeks after completing Epclusa therapy)/(number of subjects treated with Epclusa post-kidney transplantation)
次要结局
未报告次要终点