NCT01592253Unknown不适用
Investigation of the Safety and Immunologic Biomarker After Conversion From Calcineurin Inhibitor to Rapamune in Stable Renal Transplant Recipient
适应症
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- biopsy proven acute rejection
研究概览
简要总结
For patients who meet the inclusion criteria and who agree to participate in this study, the investigators sampled peripheral blood 10cc and performed the analysis for immunologic profile just before the conversion of immune suppressant. At 1 month, 6 month, and 1 year from the conversion of Immune suppressant (CNI to rapamune), the investigators performed tha analysis fo immune profile again. During the study period, the interval of the visit of subclinic and the kinds of laboratory test (Blood and urine test) would not change compared to before the start of this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Renal transplant recipient who has passed at least 10 years
- •No acute rejection episode during the previous 6 months
- •No change of prescription of immune suppressants
- •Normal allograft function (MDRD eGFR > 80 mL/min/1.73 m2)
- •Change of allograft function less than 10 % of baseline value durant the previous 1 year
- •No proteinuria and hematuria
排除标准
- •Patients who donut want to participate in this study
- •Patients who should continue immune suppressant due to another cause (e/g combined autoimmune disease)
结局指标
主要结局
biopsy proven acute rejection
时间窗: Study duration is 12 months
Number of episode of biopsy proven acute rejection
次要结局
- Serum Creatinine, MDRD eGFR(Study duration is 12 months)
研究者
ChulWoo Yang
professor
Seoul St. Mary's Hospital
研究点 (1)
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