NCT01974999已完成不适用
A Retrospective Multicenter Study to Determine 5-Year Clinical Outcomes in Subjects Previously Enrolled in the CTOT-01 Study (CTOT-17)
National Institute of Allergy and Infectious Diseases (NIAID)7 个研究点 分布在 2 个国家目标入组 184 人开始时间: 2013年10月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 7
- 主要终点
- Change in estimated glomerular filtration Rate (eGFR) from 6 months to 5 years post-transplantation
研究概览
简要总结
This study is a multicenter, non-randomized, retrospective study to collect long term (5 years post-transplant) clinical outcome data to test whether the results of the noninvasive immune monitoring test strategy performed in the parent study (CTOT-01, NCT00308802) in first six-month post-transplant is predictive of 5-year outcomes. Each center will complete a retrospective chart review for the data on patient survival, graft survival and renal function.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants previously enrolled in the CTOT-01 study.
- •Participants who are at least 5 years post-transplant (+/- 6 months), no later than March 31, 2014.
排除标准
- •Withdrawal of consent to continue in the CTOT-01 study.
结局指标
主要结局
Change in estimated glomerular filtration Rate (eGFR) from 6 months to 5 years post-transplantation
时间窗: Day 1
Modification of Diet in Renal Disease (MDRD) in the adult cohort and Schwartz method in the pediatric cohort
次要结局
- Change in Chronic Kidney Disease stages between transplant and 5 years post- transplant(Day 1)
- Renal function as assessed by the absolute glomerular filtration Rate (GFR) at 5 years post-transplant(Day 1)
- Patient survival as assessed by the incidence of death reported in the first 5 years post- transplant(Day 1)
- Graft survival as assessed by the incidence of graft loss reported in the first 5 years post- transplant(Day 1)
研究者
研究点 (7)
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