A Prospective, Randomized, Multicenter, Open-Label, Pilot Study to Investigate Medication Adherence & Patient Reported Symptom Occurrence & Interference w/ Daily Life Comparing Envarsus XR® & Immediate Release Tacrolimus in Adult Renal Transplant Recipients (SIMPLE)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 261
- 试验地点
- 3
- 主要终点
- Mean Change in Calcineurin Inhibitor-related Symptoms Severity Score
研究概览
简要总结
The purpose of this study is to compare once-daily tacrolimus extended-release (Envarsus XR®) to twice-daily immediate release tacrolimus to find out if people taking tacrolimus extended release (Envarsus XR®) report fewer side effects, increased medication compliance and higher scores on quality of life assessments compared to people taking twice daily tacrolimus immediate release.
详细描述
Despite improvement in short-term graft outcomes in organ transplant, transplant patients still have to take on complex medication regimens to achieve current results. Adherence to these complex medications is an important problem in light of the potential risk of acute and chronic rejection and the associated burden of increased hospitalization, cost, and diminished quality of life that results from missed doses and poor overall drug taking. Part of the diminished quality of life is also tied to the bothersome symptoms patient feel after transplant. Most patients experience symptoms that relate to either the overall transplant immunosuppression or medication specific side effects. In the BENEFIT and BENEFIT-EXT trials, >60% of patients reported tiredness and lack of energy as an issue. Sleep problems, mood swings, restlessness, anxiety, depression, and concentration and memory difficulties appeared in approximately 50-60% of patients. In addition to these symptoms, >38% patients also reported numerous others side effects that have been strongly associated with calcineurin-inhibitors such as tacrolimus that include dizziness, muscle cramps, trembling hands, tingling in hands and feet, and headache.
The investigators hypothesize that the use of once-daily Envarsus XR® could decrease some transplant- and tacrolimus-related adverse symptoms and potentially lead to improvement in quality of life and medication adherence when compared to twice-daily tacrolimus. In order to assess this hypothesis, a prospective, multi-center, randomized, open-label, pilot study to investigate medication adherence and patient reported symptom occurrence and interference with daily life comparing once-daily Envarsus XR® and twice-daily immediate release tacrolimus in adult renal transplant recipients (SIMPLE) is being proposed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Patient is an adult (18 years of age or older).
- •Treatment with Envarsus XR® or immediate-release, twice-daily tacrolimus has been indicated by patient's transplant care team.
- •Patient is a recipient of a deceased or living donor kidney transplant.
- •Patient is able to comply with study procedures for the entire length of the study.
- •Patient has been informed about the study survey and has signed an informed consent form.
排除标准
- •Patient is unable or unwilling to complete study patient reported outcome questionnaires.
- •Patient is currently receiving azathioprine
- •Patient is currently receiving an mTOR inhibitor (sirolimus, everolimus)
- •Patient is currently receiving an belatacept
- •Patient has received investigational immunosuppression 1 month prior to transplant or post-transplant
- •Patient is in a setting where a professional care taker is responsible for dispensing subject's medication.
研究组 & 干预措施
Tacrolimus twice-daily
Subjects assigned to this arm will take tacrolimus two times daily by mouth, at the clinically prescribed dose.
干预措施: Tacrolimus twice daily (Drug)
Envarsus XR
Subjects assigned to this arm will take Envarsus XR one time daily by mouth, at the clinically prescribed dose.
干预措施: Envarsus XR (Drug)
结局指标
主要结局
Mean Change in Calcineurin Inhibitor-related Symptoms Severity Score
时间窗: Baseline; 12 months
The CIRS is a questionnaire that assesses five symptoms (from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events \[PRO-CTCAE\]) that have been shown to be associated with calcineurin inhibitors. These symptoms include trembling hands, muscle cramps, muscle weakness, swollen gums, and increased hair growth. Each symptom is based on symptom severity in the last 7 days scaled from 0 (none) - 4 (very severe). The cumulative score ranges from 0-20, with higher scores indicating a worse outcome.
次要结局
- Correlation Between de Novo DSA and Degree of Taking and Timing Adherence(4 months; 12 months)
- Adverse Events(12 months)
- Change in the Severity Score in Each of the Five Individual CIRS Items(Baseline; 12 months)
- Number of Subjects With a Moderately Severe, Severe or Very Severe Score on Any CIRS Item(12 months)
- Change in the Number of Subjects Who Had a Reduction in Severity of Calcineurin Inhibitor-related Symptoms(4 months; 12 months)
- Change in the Number of Subjects Who Had at Least One Calcineurin Inhibitor-related Symptom Reduced by 1 Point or Greater(4 months; 12 months.)
- Transplant-related Symptoms as Measured by the Difference in Mean Transplant-related Symptoms (TRS) Score.(Baseline; 12 months)
- Change in Health-related Quality of Life (HRQoL), as Measured by the Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29) Health Profile.(Baseline; 12 months)
- Change in Transplant-related Symptoms as Measured by the Difference in Transplant-related Symptoms (TRS) Score in for Each Individual Symptom(Baseline; 12 months)
- Change in Overall Tolerability or Patient Bother Due to Side Effects(Baseline; 12 months)
- Change in Medication Adherence(12 months)
- Change in Patient Medication Satisfaction as Assessed by Question 14 of the Treatment Satisfaction Questionnaire for Medication.(Baseline; 12 months)