The Effect of Conversion to Once-Daily Envarsus® on the Neurologic Toxicity Burden in Liver Transplant Recipients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Neurotoxicity Burden
研究概览
简要总结
This study will compare neurologic side effects associated with two immunosuppressant medications used in liver transplant patients. The standard therapy of twice daily immediate release Tacrolimus will be compared to Envarsus once daily. We hypothesize that Envarsus will show a lower rate of neurologic side effects than immediate release tacrolimus.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female adult (≥18 years old) with a history of liver or liver/kidney transplant within the first 6 months of transplant.
- •Patients must be capable of understanding the purposes and risks of the study and have the ability to give written informed consent and be willing to participate and comply with the study.
排除标准
- •Patients will be excluded if they are pregnant or nursing females or males with a pregnant female partner
- •HIV positive (HIV ab +)
- •Unable to tolerate oral medications
- •Use of another investigational product within thirty days prior to receiving study medication
- •Moderate acute cellular rejection (RAI ≥ 5) within the past month
- •A condition that is known to cause tremor such as essential tremor, Parkinson disease, or enhanced physiologic tremor.
- •Patients taking medications known to induce tremors or dopamine blocking agents
- •A condition or disorder that, in the opinion of the investigator, may adversely affect the outcome of the study or the safety of the subject
研究组 & 干预措施
Arm 1: Control
Tacrolimus immediate release twice daily for 6 months
干预措施: Tacrolimus Immediate release (Drug)
Arm 2: Intervention
Envarsus daily for 6 months.
干预措施: Envarsus (Drug)
结局指标
主要结局
Change in Neurotoxicity Burden
时间窗: 6 months
Estimate the change from baseline to six months in neurotoxicity burden measured by a composite Patient Global Impression of Improvement score (PGI-I, with a range of 4-28) The PGI-I is a global index that may be used to rate the response of a condition to a therapy (transition scale). Scale min=4, scale max=28. The scale is made up of four questions, each question has a total of 7 responses, the total score is the sum of each questions choice (1-7). Higher values represent a worsening condition. A score of 16 would indicate no overall change. A score of 15 or lower indicates improvement in the condition and a score of 17 or higher indicates a worsening of the condition. A score of 28 would indicate "very much worse," while a score of 4 would indicate "very much better." A relative change of 2 points would be considered a significant change from baseline.
次要结局
未报告次要终点
研究者
David J. Taber
Professor-Faculty
Medical University of South Carolina