A Randomized Open Label Trial of Oral Sirolimus for Decrease of Stenosis in Arteriovenous Fistula in Hemo-dialysis Patients When Compared With Standard Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Comparison of the sirolimus group to the control group from time of assisted primary and secondary patency rates to access abandonment
研究概览
简要总结
Dialysis patients presenting for angioplasty intervention for graft failure will be randomized to receive either Sirolimus or not receive Sirolimus (standard of care) to assess the time from primary failure or angioplasty intervention to second or next angioplasty intervention or graft failure.
详细描述
This is a randomized control study to determine the feasibility of using sirolimus peri-angioplasty to compare the time from primary failure or angioplasty intervention to second or next angioplasty intervention or graft failure to a control group who would not have received Sirolimus
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
- 未提供
排除标准
- •A woman who is pregnant or breastfeeding
- •Active malignancy
- •Concomitant treatment with immunosuppressant medications
- •Active infection or treated for infection within the last 30 days
- •Pre-existing interstitial lung disease
- •Thrombocytopenia with platelets less than 100 109/L
- •Previous renal or other solid organ transplant
- •Preexisting liver failure
- •Life expectancy less than 6 months
- •Planned major surgery or major surgery within the last 6 months
- •History of malignancy within the previous 5 years (with the exception of adequately treated basal cell or squamous cell carcinoma of the skin).
- •Known history of any coronary intervention within the 6 months prior to current screening
- •Prior or current use of Sirolimus or any of its derivatives within 3 months prior to angioplasty
- •Active gastrointestinal disorder that may interfere with drug absorption
- •Known to be HIV positive or known active hepatitis B or C infection
- •Treatment with voriconazole, terfenadine, cisapride, astemizole, pimozide, or ketoconazole (known to interact with Sirolimus) that is not discontinued before starting Sirolimus treatment.
研究组 & 干预措施
Sirolimus
Participants will take sirolimus for 3 days prior to procedure and 30 days post procedure.
干预措施: Sirolimus (Drug)
结局指标
主要结局
Comparison of the sirolimus group to the control group from time of assisted primary and secondary patency rates to access abandonment
时间窗: 12 months
Comparison of the sirolimus group to the control group from time of assisted primary and secondary patency rates to access abandonment
次要结局
- Secondary End point(12 months)