DBS for Home Monitoring in Children With Kidney Transplantation
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 2 - 21 |
| Updated: | 3/18/2017 |
| Start Date: | July 2013 |
| End Date: | February 2015 |
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.
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.
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
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
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
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