An Open Label, Proof of Concept Study to Evaluate the Feasibility and Safety of Kidney Transplant From HCV Positive Donors Into HCV Negative Recipient
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Proportion of Patients With Undetectable Hepatitis C Virus (HCV) Polymerase Chain Reaction (PCR) at 12 Weeks After Completion of HCV Treatment
研究概览
简要总结
To evaluate the safety and feasibility of transplanting kidneys from Hepatitis C virus (HCV) infected donors into recipients without HCV infection
详细描述
This will be an open label, prospective, interventional, proof of concept study to evaluate the feasibility and safety of kidney transplant from HCV positive donors into HCV negative recipients using treatment with pan-genotypic direct acting antiviral therapies (DAAS) for treatment of post-transplant HCV transmission
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
- •Adult age >18 years able to provide consent
- •Lack of available living donor
- •Calculated pre-transplant reactive panel (cPRA) of <80%
- •Estimated post-transplant survival (EPTS) index >20% and <80%
- •Negative pre-transplant human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis B virus (HBV) serology and blood HCV polymerase chain reaction (PCR)
- •No clinically significant pre-transplant liver disease
排除标准
- •Living donor available
- •Dialysis time >5 years
- •Listing for multi-organ transplantation
- •Active or recent history (<6 months) of alcohol abuse or substance abuse
- •Clinically significant liver disease as determined by principal investigator
- •History of hepatocarcinoma
- •Pregnancy or lactation
- •Refusal to accept blood transfusion
- •HIV infection
- •HCV pcr or antibody positive
- •HBV infection
- •Donor Inclusion Criteria:
- •Positive HCV PCR at time of donation
- •Kidney donor profile index (KDPI)<85%
研究组 & 干预措施
Intervention group
kidney transplant recipients who receive kidney allograft from hepatitis C viremic donors followed by treatment with direct acting antiviral therapies.
干预措施: Sofosbuvir / Velpatasvir Oral Tablet [Epclusa] (Drug)
Intervention group
kidney transplant recipients who receive kidney allograft from hepatitis C viremic donors followed by treatment with direct acting antiviral therapies.
干预措施: Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet [MAVYRET] (Drug)
结局指标
主要结局
Proportion of Patients With Undetectable Hepatitis C Virus (HCV) Polymerase Chain Reaction (PCR) at 12 Weeks After Completion of HCV Treatment
时间窗: 12 weeks
Proportion of patients with undetectable hepatitis C virus (HCV) polymerase chain reaction (PCR) at 12 weeks after completion of HCV treatment was to test the efficacy of the treatment.
Elevation in Liver Enzyme >5 Times the Upper Limits, Development of Acute Cholestatic Hepatitis , or Intolerance to Direct Acting Antiviral Therapies
时间窗: 12 weeks
Elevation in liver enzyme \>5 times the upper limits, development of acute cholestatic hepatitis , or intolerance to Direct acting antiviral therapies was to test the safety of utilizing HepC positive kidneys for transplant.
次要结局
- Estimated Glomerular Filtration Rate (eGFR) at 6 and 12 Months Post-transplant(6 and 12 months)
- Patient's Survival at 6 and 12 Months(6 and 12 months)
- Graft Survival at 6 and 12 Months(12 months)
研究者
Reem Daloul
Assistant Professor of Clinical Medicine, Transplant Nephrology
Ohio State University