Reduction of BK Viremia in Kidney Transplant Patients Using the Seraph 100 Microbind® Affinity (Seraph 100) Blood Filter
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in log 10 viral load
研究概览
简要总结
Reduction of BK Viremia by treating kidney transplant patients.
详细描述
a clinical investigation plan (CIP) for the "Reduction of BK viremia in kidney transplant patients using the Seraph 100 Microbind® Affinity (Seraph 100) Blood Filter" clinical study, where BK is an abbreviation of the name of the first patient whom the virus was isolated from in 1971. This clinical study is intended to evaluate the reduction of BK viremia by treating kidney transplant patients with the Seraph 100 Microbind® Affinity Blood Filter from ExThera Medical. This clinical study is sponsored by ExThera Medical Corporation.
This clinical study will be conducted in accordance with this CIP. All parties involved in the conduct of the clinical study will be qualified by education, training, or experience to perform their tasks and this training will be documented appropriately.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Kidney transplant patients with a BK-viraemia ≥ 10,000 IU/ml.
- •Be ≥ 18 years old and ≤ 90 years old
- •Existing hemodialysis access
排除标准
- •Subject is currently participating in another clinical investigation
- •Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period
- •Presence of comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results
- •Have Child-Pugh Class C cirrhosis
- •Have platelet count <30.000/uL
- •Contraindications for heparin sodium for injection
- •Subjects demonstrating any contraindication for this treatment as described in the IFU
- •Patients without existing hemodialysis access
研究组 & 干预措施
Treatment
Treatment with Microbind® Affinity Blood Filter
干预措施: Extracorporal therapy (Device)
Control
Antibiotics
结局指标
主要结局
Change in log 10 viral load
时间窗: At day 0 and the following 3 treatments within five days after beginning with the first treatment.
Time-weighted change from baseline in log10 viral load within five days after first treatment.
次要结局
- Number of participants with inoperative hypotension(At 0 and the following 3 treatments within five days after beginning with the first treatment.)
- Number of participants with increase in serum creatinine(At day 0 and the following 3 treatments within five days after beginning with the first treatment.)
- Number of participants with decreasing haemoglobin measurements(At day 0 and the following 3 treatments within five days after beginning with the first treatment.)
- Number of participants with leukopenia(At day 0 and the following 3 treatments within five days after beginning with the first treatment.)