DBS for Home Monitoring in Children With Kidney Transplantation

Kidney Disease Clinical Trial

— DBS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01931397
• Other study ID #: PROG-12G03
• Status: Completed
• Phase: N/A
• First received: August 16, 2013
• Last updated: March 16, 2017
• Start date: July 2013
• Est. completion date: February 2015

Study information

• Verified date: March 2017
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Disease
• Kidney Diseases

Locations

Country	Name	City	State
United States	Doernbecher Children's Hospital /OHSU	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	Astellas Pharma US, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean Tacrolimus Blood Levels Measured by DBS Over Study Period According to Age	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
Other	Changes in Adherence Parameters to Home DBS Method	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
Primary	Variability of Tacrolimus Blood Levels Measured by DBS Over Time	Mean standard deviation scores for Tacrolimus blood levels obtained by DBS for each patient over time.	12 months
Secondary	Percentage of Families Preferring DBS Method	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