The Induction Agent Effect on BK Viremia in Renal and Pancreas Transplant Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- BK Virus Viremia titer, >400 copies by Polymerase Chain Reaction (PCR)
研究概览
简要总结
The increase immunosuppression in our transplant population has led to an unacceptable rate of patients at risk for BK virus nephropathy. Reducing induction immunosuppression by switching from Thymoglobulin to Simulect will reduce the incidence of serum positivity for BK by PCR.
详细描述
Our standard of care has been changed from Thymoglobulin to Simulect and now patients were enrolled in this observational trial to gather data on their outcomes related to BK viremia and rejection rates. Two groups of patients were compared.
Retrospective (historical or control) group of subjects: patients who had received a kidney transplant and were inducted with Thymoglobulin prior to study initiation.
Prospective group of subjects: patients who is scheduled to receive kidney transplant and will be inducted with Simulect (Basiliximab).
Inductions in both groups was/is Standard of Care at a time of treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •De novo transplant
- •Aged 18-75
排除标准
- •Serious medical condition which, in the opinion of the Principal Investigator, might interfere with the subject's ability to successfully complete the protocol.
- •Any medical condition which, in the opinion of the Principal Investigator, might compromise the safety of the subject in participating in the protocol
结局指标
主要结局
BK Virus Viremia titer, >400 copies by Polymerase Chain Reaction (PCR)
时间窗: One year
BKVV (BK Visus Viremia) titer is measured by PCR at 1, 3,6,9 and 12 month time points.
次要结局
- Incidence of Acute Rejection of Transplanted Kidney(One year)