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DBS for Home Monitoring in Children With Kidney Transplantation (DBS)

2017年3月16日 更新者:Amira Al-Uzri、Oregon Health and Science University

Novel Use of Dried Blood Spots (DBS)for Home Monitoring in Children With Kidney

Kidney transplantation is the treatment of choice for kidney failure in children. Kidney transplant recipients need to take immunosuppression for the rest of their lives after transplantation to prevent rejection of the graft. One of the important medications is called Tacrolimus which can prevent rejection of the kidney graft but at the same time is toxic to the kidney. Therefore, repeated blood levels of Tacrolimus with tests of kidney function will help physicians to prescribe the best dose for therapy to prevent kidney rejection and kidney toxicity. Failure of compliance with taking Tacrolimus is also an important cause of graft failure especially among teenagers, so repeated blood Tacrolimus levels are necessary to detect patients who fail to take their medications on a regular basis. We have developed a lab assay that measures Tacrolimus blood level and creatinine (for kidney function) using one dried blood spot (DBS) on filter paper similar to the filter paper used in the new born screen. We plan to teach patients how to do the test at home once a month and mail the filter paper back to OHSU for analysis for Tacrolimus and creatinine. The advantage of this method is that it is less painful for children then a regular blood dray from the vein, can be done easily at home, will be most cost effective as it will save the family a day of work or school and can detect both the Tacrolimus level and the kidney function at the same time.

We will assess the effect of doing this simple finger prick at home on compliance, on Tacrolimus levels and kidney function over the study period of one year. We will also assess how satisfied patients are with this method instead of going to the lab or the hospital for blood test. All subjects will continue on their regular clinic visits and will continue to have their routine blood draws by intravenous method in the lab during the study.

研究概览

地位

完全的

条件

详细说明

Specific Aim 1: To validate the DBS method as a home monitoring device for use at home by parents and patients in 30 pediatric kidney transplant recipients. We will validate the TAC and creatinine (Cr) blood levels obtained by DBS method in comparison to blood TAC and serum creatinine levels using standard laboratory assays in CLIA approved clinical laboratories.

Specific Aim 2: The use of DBS on filter papers is associated with better adherence to monthly blood testing and medication intake. This aim can be tested by assessing the number of DBS on filter papers that are returned to OHSU every month. Adherence with medication intake will be assessed by measuring the variability of TAC trough levels, and by individual reporting.

We will calculate the percent of returned DBS filter papers to OHSU on a monthly basis as well as the percent of those that are collected properly at home and are successfully utilized for TAC and Cr analysis.

Specific Aim 3: This aim will explore patient and family satisfaction and self management using DBS method vs. the standard method of scheduled clinic and laboratory visits.

Design: This is a pilot study to evaluate and validate the novel use of DBS on filter paper as a home monitoring method. This study will involve within-subjects, repeated measures design to test specific hypotheses.

Participants: The pediatric kidney transplant program at Doernbecher Children's Hospital/OHSU follows approximately 120 active renal transplant recipients between 2-21 years. Thirty patients of both genders will participate in this study and will be followed for one year.

Inclusion criteria:

  1. On Tacrolimus immunosuppression therapy
  2. At least six months post kidney transplantation

研究类型

观察性的

注册 (实际的)

30

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

    • Oregon
      • Portland、Oregon、美国、97239
        • Doernbecher Children's Hospital /OHSU

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

2年 至 21年 (孩子、成人)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

children who are followed at the Pediatric Kidney Transplant CLinic at OHSU.

描述

Inclusion Criteria:

Kidney transplant recipients between the ages of 2-21 years at time of enrollment

  1. On Tacrolimus immunosuppression therapy
  2. At least six months post kidney transplantation

Exclusion Criteria:

Not on tacrolimus therapy Less than 6 months after kidney transplantation Refusal to provide consent fomr

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

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
Variability of Tacrolimus Blood Levels Measured by DBS Over Time
大体时间:12 months
Mean standard deviation scores for Tacrolimus blood levels obtained by DBS for each patient over time.
12 months

次要结果测量

结果测量
措施说明
大体时间
Percentage of Families Preferring DBS Method
大体时间:At baseline and then at 12 months

The % of families who anticipated preference of DBS method over intravenous blood draws at the time of enrollment and then the % of those who preferred DBS at end of study period (12 months).

Families include parents/caregivers and participants who are over 10 years of age were asked to fill in the preference scale separately.

Preference for DBS Testing was measured using a Visual Analog Scale (VAS) on which a zero was equivalent to no preference for DBS versus laboratory-based monitoring and on which positive numbers indicated greater preference for DBS (up to +72) and negative scores indicated a greater preference for laboratory-based monitoring (down to -72).

At baseline and then at 12 months

其他结果措施

结果测量
措施说明
大体时间
Mean Tacrolimus Blood Levels Measured by DBS Over Study Period According to Age
大体时间:up to 12 months
Mean Tacrolimus blood levels obtained by DBS in each patient over their time in the study in children who are 12 years and over versus those less than 12 years of age.
up to 12 months
Changes in Adherence Parameters to Home DBS Method
大体时间:At baseline then every 3 months for 12 months

We will calculate the percent of returned DBS filter papers to OHSU on a monthly basis utilized for TAC and Cr analysis.

we calculated the percentage as the number of DBS that were actually received divided by the total number of DBS expected to be received from participants over the study time period

At baseline then every 3 months for 12 months

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:Amira Al-Uzri, MD, MCR、Oregon Health and Science University

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

2013年7月1日

初级完成 (实际的)

2015年2月1日

研究完成 (实际的)

2015年2月1日

研究注册日期

首次提交

2013年8月16日

首先提交符合 QC 标准的

2013年8月26日

首次发布 (估计)

2013年8月29日

研究记录更新

最后更新发布 (实际的)

2017年3月17日

上次提交的符合 QC 标准的更新

2017年3月16日

最后验证

2017年3月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • PROG-12G03

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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