DRKS00024859尚未招募2 期
Reduction of BK viremia in kidney transplant patients using the Seraph 100 Microbind® Affinity (Seraph 100) Blood Filter - CP026
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 90 Years（—）
- 性别
- All
入选标准
- •1. Kidney transplant patients with a BK-viraemia = 10,000 IU/ml
- •2. Be = 18 years old and = 90 years old
- •3. Existing hemodialysis access
排除标准
- •1.Subject is currently participating in another clinical investigation
- •2. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period
- •3. 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
- •4. Have Child-Pugh Class C cirrhosis
- •5. Have platelet count <30.000/uL
- •6. Contraindications for heparin sodium for injection
- •7. Subjects demonstrating any contraindication for this treatment as described in the IFU
- •8. Patients without existing hemodialysis access
研究者
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