RENAL: Randomized Clinical Trial of TNF-alpha Inhibitor for Improving Renal Dysfunction and Primary Graft Dysfunction After Lung Transplant
试验速览
- 阶段
- 早期 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Occurrence of kidney dysfunction immediately after lung transplant
研究概览
简要总结
The purpose of this study is to assess whether TNFa antibody use before lung transplant can prevent kidney injury after lung transplant.
详细描述
After being informed about the study and potential risks, all patients giving written consent who undergo a lung transplant will be randomized in a 1:1 ratio to either the treatment or control group. Patients randomized to the treatment group will receive one dose of the study drug, Etanercept, via subcutaneous injection just prior to the lung transplant. Patients randomized to the control group will not receive Etanercept. Both groups will receive standard lung transplant care after implantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Planning to undergo transplantation of the lung at Northwestern Memorial Hospital.
- •Willing and able to read, understand, and be capable of giving informed consent.
排除标准
- •Previous or current use of TNFa antibody.
- •Positive virtual or retrospective crossmatch or highly sensitized (pRA > 30%) recipients.
- •Any condition that, in the opinion of the attending physician, would place the patient at undue risk by participating.
研究组 & 干预措施
Etanercept
Participants receive one dose (25mg) Etanercept via subcutaneous injection just prior to lung transplant. Following transplant, participants receive standard lung transplant care.
干预措施: Etanercept Injection [Enbrel] (Drug)
Control
Participants receive standard lung transplant care.
结局指标
主要结局
Occurrence of kidney dysfunction immediately after lung transplant
时间窗: Immediately after lung transplant
Measured by serum creatinine blood tests
Occurrence of kidney dysfunction post-operatively within 1 month after lung transplant
时间窗: Up to 30 days after lung transplant
Measured by serum creatinine blood tests
Occurrence of kidney dysfunction post-operatively within 1 week after lung transplant
时间窗: Within 1-7 days after lung transplant
Measured by serum creatinine blood tests
次要结局
- Length of intensive care unit (ICU) stay(Through study completion, an average of 1 year)
- Occurrence of primary graft dysfunction(Within 3 days post-transplant)
- Length of ventilator use(Through study completion, an average of 1 year)
- Survival(30 days, 90 days, and one year survival post-transplant)
研究者
Chitaru Kurihara
Instructor of Surgery, Feinberg School of Medicine
Northwestern University