A Pilot Study of Stable Kidney Transplant Recipients Taking Tacrolimus With CNS Symptoms Switched to Envarsus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Quality of Life
研究概览
简要总结
This is a pilot study documenting the neurotoxic side effects including tremors in patients with a stable graft who are receiving Tacrolimus following kidney transplantation. A standardized questionnaire will be used to document these symptoms.
详细描述
Immunosuppressive therapies have burdensome side effects which may lead to sub-therapeutic dosing and non-compliance.
This study provides renal transplant patients the opportunity for an alternative treatment using tacrolimus, with possible less Central Nervous Symptom (CNS) side effects. CNS side effects are one of the main reasons that patients complain about after having a kidney transplant while on tacrolimus (Prograf). The side effects can be debilitating and can affect the patient's overall well-being. In severe cases it may lead to non-compliance. The advantage of the study of using Envarsus is the ability to avoid these debilitating CNS side effects and afford better compliance with the patients taking the medicine.
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
- •Kidney transplant recipients with stable graft function.
- •More than 1 months post-transplant.
- •18+ years of age with some CNS problems secondary to Prograf (tacrolimus).
排除标准
- •Multi-organ patients (kidney/pancreas, kidney/liver).
- •Evidence of graft rejection or treatment of acute rejection within 14 days prior to baseline visit.
- •Inability to self-administer the QOL questionnaires.
研究组 & 干预措施
Envarsus XR
A form of the anti-rejection drug, tacrolimus, for people who have had a kidney transplant.
干预措施: Envarsus XR (Drug)
结局指标
主要结局
Change in Quality of Life
时间窗: Baseline, 1 Month, 6 Months
The Investigators will evaluate the quality of life between baseline and 6 months related to sleep disturbance and upper extremity fine motor skills/ADL (activities of daily living), with the goal to be an improvement in their quality of life. This was assessed via a study-specific clinical assessment that evaluated patient reports of hand tremor and related complaints, and scored in a range of 0 to 3, with higher scores indicating worse symptoms of hand tremor, and a lower QOL.
次要结局
- Therapeutic Tacrolimus Drug Levels(Baseline, 1 Month, 6 Months)
- Kidney Function: Serum Creatinine Levels(Baseline, 1 Month, 6 Months)