Assessment of Cognitive Function Before and After Conversion From Immediate Release Tacrolimus to Envarsus XR
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- cognitive assessment at baseline
研究概览
简要总结
The purpose of this study is to determine if cognitive function improves in patients converted from tacrolimus immediate release (TAC IR) to Envarsus XR® (tacrolimus extended release) using an objective measure of cognition.
详细描述
To assess cognitive function while on TAC IR and then three months after conversion to TAC XR using a traditional cognitive assessment, Montreal Cognitive Assessment (MoCA), and a broader cognitive assessment. This assessment will be used to determine if there is an objective improvement in cognitive function after conversion from TAC IR to TAC XR in kidney transplant recipients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Post-renal transplant on stable TAC IR for at least 6 months who are converting to TAC XR regardless of indication.
- •Patients receiving their post-transplant care through the Yale-New Haven Transplantation Center (YNHTC) regardless of where they were originally transplanted.
排除标准
- •History of dementia or stroke
- •Reside in a nursing home
- •Newly started on an opiate, amphetamine, or benzodiazepine
- •Non-English speaking (due to lack of NIH toolbox assessments in other languages)
- •Patients that exhibit signs of acute infection, hemodynamic compromise or other signs of critical illness (e.g. respiratory distress requiring mechanical ventilation)
- •Recipients of a multiorgan transplant
- •Pregnant women
- •Transplant recipients unable to provide informed consent to participate in this research
研究组 & 干预措施
adult kidney transplant recipients
Adult kidney transplant recipients on tacrolimus immediate release for at least six months who are being converted to tacrolimus extended release Envarsus XR® (TAC XR) for any reason by a transplant nephrologist and are willing to participate in cognitive assessment will be offered the opportunity to participate in the study. An assessment is also made at the 3 month point as baseline.
干预措施: Tacrolimus, Extended Release, (Envarsus Xr) (Drug)
结局指标
主要结局
cognitive assessment at baseline
时间窗: baseline
cognitive assessment at baseline using MoCA test 7.1
cognitive improvement from baseline
时间窗: 3 months after enrollment
cognitive evaluation from baseline average for adults using NIH Toolbox Cognitive Domain
次要结局
- NIH Toolbox cognitive test(3 months)
- MoCA cognitive assessment(3 months after enrollment)