DBS for Home Monitoring in Children With Kidney Transplantation
Condition: Kidney Disease
MeSH terms: Kidney Diseases
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        children who are followed at the Pediatric Kidney Transplant CLinic at OHSU.
      
Keywords: Dried blood spots; kidney transplant; Children