A Pilot Study to Evaluate Impact on Neurological Side Effects (Cognition, Memory, and Tremor) in Elderly (Age>65) Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Change in Neurocognitive Side Effects
研究概览
简要总结
Previous studies have shown that elderly patients experience higher trough levels of tacrolimus and are more sensitive to the effects of medications, they experience higher occurrence and severity of such medication related toxicities. Therefore, the investigators hypothesize that by transitioning patients from tacrolimus immediate release to Envarsus ®, the peak-dose effect will be eliminated or attenuated, leading to a significant decrease in neurocognitive toxicities in the older patient population.
详细描述
The investigators will conduct a single-center, prospective, open-label, randomized study to evaluate the difference in neurocognitive side effects between Envarsus and immediate release tacrolimus. Eligible patients will be enrolled within 8 weeks post-transplantation. They will be administered a baseline panel of neurocognitive tests. They will then be randomized to either continue on immediate release tacrolimus or Envarsus. 6 weeks after randomization, the neurocognitive tests will be repeated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recipient of a kidney transplant
- •Age 60 or greater at the time of transplant
- •Kidney graft is functional (not dialysis dependent) by 4 weeks post-transplant
- •Have IR tacrolimus as maintenance therapy
- •Have BMI < 35 at time of transplant
- •Achieve therapeutic tacrolimus level within 4 weeks post-transplant
排除标准
- •Recipient of a simultaneous non-kidney transplant (pancreas)
- •Had an episode of rejection before study enrollment
- •Had a TIA/CVA after transplantation and before study enrollment
- •Had a neurologic injury after transplantation and before study enrollment
- •Have an mTOR inhibitor as maintenance therapy
- •Nonadherence, as determined by a trough level less than 7 ng/mL after achieving therapeutic level with no other rationale for sub-therapeutic levels.
- •Adults unable to consent
- •Pregnant women
研究组 & 干预措施
Immediate Release Tacrolimus
Patients will receive immediate release tacrolimus
干预措施: IR Tacrolimus (Drug)
Envarsus
Patients will be converted to Envarsus formulation of tacrolimus
干预措施: Envarsus (Drug)
结局指标
主要结局
Change in Neurocognitive Side Effects
时间窗: 6 weeks after randomization and baseline testing
Change in MOCA (Montreal Cognitive Assessment) from baseline to study end. MOCA scale runs from 0 to 30 with higher being a better outcome. Change in DSST (Digital Symbol Substitution Test) from baseline to study end. DSST scale runs from 1 to 125 with higher being a better outcome.
次要结局
- Change in Self-reported Side Effects(6 weeks after randomization and baseline testing)
- Kidney Graft Survival(6 months after transplant)
- Patient Survival(6 months after transplant)