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Immunosuppressant Medication Dosed Daily After Kidney Transplant

2020年11月30日 更新者:University of Colorado, Denver

Kidney Immunosuppression Dosed Daily Only (KIDDO) - A Pilot Study

Medication non-adherence is a major risk factor for graft dysfunction and graft loss among pediatric and adult transplant recipients. Rates of non-adherence in these populations are estimated between 30 and 70%, with the highest prevalence in adolescent and young adult (AYA) transplant recipients. Treatment-related factors known to impact rates of adherence include the number of medication doses per day and the number of tablets or capsules a patient takes per day, or "pill burden". One approach to minimizing dosing frequency and pill-burden includes transitioning patients to once-daily formulations. The current literature investigating utilization of once-daily immunosuppressive regimens in the AYA kidney transplant population is limited.

研究概览

详细说明

One approach to minimizing dosing frequency and pill-burden includes transitioning patients to once-daily formulations.3 The current literature investigating utilization of once-daily immunosuppressive regimens in the AYA kidney transplant population is limited. Two studies have demonstrated safe and effective conversion of twice-daily tacrolimus to the Astagraf® in stable pediatric solid organ transplant recipients.4,5 Patients maintained equivalent tacrolimus exposure and experienced similar rates of rejection and graft loss in the first year post-conversion.5 To date, experience with another once-daily extended release (XR) tacrolimus product, Envarsus XR®, has not been published in the AYA population. Additionally, adherence studies evaluating a once-daily immunosuppression regimen including extended-release tacrolimus and azathioprine (which is dosed once daily as opposed to the twice daily dosing required for azathioprine's alternative mycophenolate mofetil) have not been conducted.

Of note, and even though twice-daily mycophenolate has been shown to be superior to once-daily azathioprine early post-transplant, more long-term data suggest that this advantage may not persist.6 Furthermore, a recent Cochrane review addressed the question of mycophenolate versus azathioprine as primary anti-proliferative immunosuppression for kidney transplant recipients; it concluded that "balancing the benefits and harms of the two drugs remains a major task of the transplant physician to decide which agent" is appropriate for the individual patient. 7 Moreover, once-daily immunosuppression with tacrolimus extended-release and once-daily azathioprine has been used with excellent results at a British center that focusses on AYA kidney transplant recipients.

研究类型

介入性

注册 (实际的)

1

阶段

  • 第一阶段早期

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Colorado
      • Aurora、Colorado、美国、80045
        • Children's Hospital Colorado

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

13年 至 22年 (孩子、成人)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Age 13-22 years
  2. Tanner stage 4/5
  3. "Stable" kidney transplant status, as determined by the primary transplant team
  4. At minimum 1 year post-kidney transplant or patients meeting all of the above inclusion criteria except 4) who have instead been transitioned to azathioprine by the primary transplant team due to intolerability of mycophenolate mofetil secondary to adverse medication effects (i.e. neutropenia, gastrointestinal intolerance etc.)

Exclusion Criteria:

  1. < Tanner stage 4
  2. Kidney transplant performed at an institution other than Children's Hospital Colorado, Lurie Children's Hospital of Chicago, or Cincinnati Children's Hospital
  3. Recipients of dual solid organ transplants (i.e. heart kidney, liver kidney).

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Adolescent and Young Adult (AYA) Kidney Transplant Recipients
AYA kidney transplant recipients will receive a Medication Event Monitoring System (MEMS) in the form of a medication bottle and cap system and once daily tacrolimus XR 1-10mg
AYA kidney recipients will receive a Medication Event Monitoring System (MEMS) via medication bottle and cap system
AYA kidney recipients will receive once daily tacrolimus XR 1-10mg daily
其他名称:
  • Envarus XR

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Health-Related Quality of Life: as assessed by change in PedsQL
大体时间:Day 0, Day 60, Day 210
Pediatric Quality of Life (PedsQL) Transplant Module Version 3.0 will be used to assess quality of life prior to and after transition from twice to once daily immunosuppressant medication regimen. Health-related quality of life (HRQOL) has been defined as an individual's subjective experience of their illness, and the impact that illness and its treatment have on the individual's functioning in a variety of domains. The PedsQL is a 46-item self- and parent-report measure that rates HRQOL in 8 domains (medication adherence, medication side-effects, social relationship, physical discomfort, worries regarding health status, treatment anxiety, impact on appearance, and communication). The PedsQL Transplant Module assesses physical functioning, emotional functioning, social functioning, and school functioning and was developed through focus groups, cognitive interviews, pretesting, and field testing measurement development protocols. Higher scores indicate lower problems.
Day 0, Day 60, Day 210
Adherence to medical therapies and medications: as assessed by Medication Event Monitoring System (MEMS) at Day 30
大体时间:Day 30
MEMS data will be accessed prior to transition to once-daily medications (baseline adherence) and analyzed accordingly. Dates and times in which medication bottles were opened will be recorded.
Day 30
Adherence to medical therapies and medications: as assessed by Medication Event Monitoring System (MEMS) at Day 60
大体时间:Day 60
MEMS data will be accessed the first month of transition to once-daily medications (intervention adherence) and analyzed accordingly. Dates and times in which medication bottles were opened will be recorded.
Day 60
Adherence to medical therapies and medications: as assessed by Medication Event Monitoring System (MEMS) at Day 210
大体时间:Day 210
MEMS data will be accessed 6 months after transition to once-daily medications (retention adherence) and analyzed accordingly. Dates and times in which medication bottles were opened will be recorded.
Day 210
Adherence to medical therapies and medications: as assessed by Change in Tacrolimus Trough Concentration Variance
大体时间:Day 0, Day 30, Day 60, and Day 240

Tacrolimus trough goals between 4-7ng/mL as per Transplant Immunosuppression Protocols. Student T-test, repeated measures for parametric data).

The standard deviation of tacrolimus troughs will be calculated from the 4 tacrolimus trough values obtained for clinical care purposes preceding Study Visit 1 (SD1). The standard deviation of tacrolimus troughs will be calculated again from the 4 tacrolimus trough values obtained for clinical care purposes preceding Study Visit 4 (SD2).

Day 0, Day 30, Day 60, and Day 240
Adherence to medical therapies and medications:as assessed by Change in Adolescent Medication Barriers Scale (AMBS)
大体时间:Day 0, Day 60, Day 210
17 item scale that corresponds to the Parent Medication Barriers Scale (PMBS) with 16 items. Both have strong internal consistency and are scored on a 5-point Likert scale from Strongly Disagree to Strongly Agree. A total score can be calculated, and there are subdomains of disease frustration/adolescent issues, regimen adaptation/cognitive issues, and ingestion issues, with an additional parent reminder domain on the PMBS. Lower scores indicate less barriers to medication adherence.
Day 0, Day 60, Day 210
Adherence to medical therapies and medications: as assessed by Change in The Medical Adherence Measure (MAM)
大体时间:Day 0, Day 60, Day 210
Semi-structured interview that has four general modules to assess adherence with medication, diet, exercise, and clinic attendance, as well as illness-specific modules. For the purpose of this study, the Medication and Clinic Attendance Modules will be completed. Non-adherence scores can be calculated based on the degree of adherence on a spectrum of 0%-100% adherent to capture the fluctuations and intricacies of occasional or slightly inconsistent adherence. Missed adherence score = number of doses missed out of the doses prescribed × 100%. Late adherence score = number of doses taken late out of the doses prescribed × 100%, where late is defined as greater than one hour later than the usual routine. Adherence is assessed for each medication separately and then averaged across medications.
Day 0, Day 60, Day 210

次要结果测量

结果测量
措施说明
大体时间
Long-term measures of graft and patient survival: as assessed by change in serum creatinine and urinary protein
大体时间:Day 0, Day 30, Day 60, Day 210, and Day 240
Markers of graft function will be assessed by measuring levels of serum creatinine and urinary protein. Lower serum creatinine and urinary protein indicate better long-term graft and patient survival.
Day 0, Day 30, Day 60, Day 210, and Day 240
Long-term measures of graft and patient survival: as assessed by change in markers of proteinuria
大体时间:Day 30 and Day 210
Markers of proteinuria will be assessed by urinalysis and random urinary protein/creatinine ratio. Lower urinary protein/creatinine ratio indicates better long-term measures of graft and patient survival.
Day 30 and Day 210
Long-term measures of graft and patient survival: as assessed by number of episodes of rejection
大体时间:Up to Day 240
Graft rejection episodes will be determined to have occurred if indicated by transplant biopsy results. Occurrences of graft rejection episodes among participants will be assessed up to Day 240.
Up to Day 240
Long-term measures of graft and patient survival: as assessed by change in presence of donor-specific antibody monitoring
大体时间:Day 0 and Day 240
Presence of donor-specific antibodies (DSA) prior to and after initiation of intervention.
Day 0 and Day 240
Long-term measures of graft and patient survival: as assessed by change in presence of BK virus screening results
大体时间:Day 0 and Day 240
Includes assessing the viral load to monitor presence of BK virus.
Day 0 and Day 240

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Jens Goebel, MD、Children's Hospital Colorado
  • 首席研究员:Mary Chandran, MD、Children's Hospital Colorado

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年11月20日

初级完成 (实际的)

2020年11月27日

研究完成 (实际的)

2020年11月27日

研究注册日期

首次提交

2019年11月1日

首先提交符合 QC 标准的

2019年11月5日

首次发布 (实际的)

2019年11月7日

研究记录更新

最后更新发布 (实际的)

2020年12月2日

上次提交的符合 QC 标准的更新

2020年11月30日

最后验证

2020年11月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

在美国制造并从美国出口的产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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