Kidney DiseaseDBSNCT01931397
DBS for Home Monitoring in Children With Kidney Transplantation
An observational study of Kidney Disease, run by Oregon Health and Science University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 2 to 21 years
- Conditions the study is for
- Kidney Disease
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Feb 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: children who are followed at the Pediatric Kidney Transplant CLinic at OHSU.
Who may be able to join
- Kidney transplant recipients between the ages of 2-21 years at time of enrollment
- On Tacrolimus immunosuppression therapy
- At least six months post kidney transplantation
Who cannot join
- Not on tacrolimus therapy Less than 6 months after kidney transplantation Refusal to provide consent fomr
Trial locations and contacts
1 site in 1 country.
United States1 site
Doernbecher Children's Hospital /OHSU
Portland, Oregon, 97239
About this study
Official title: 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.
Read the 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:
- On Tacrolimus immunosuppression therapy
- At least six months post kidney transplantation
- Conditions
- Kidney Disease
- Keywords
- Dried blood spots, kidney transplant, Children
- Medical subject headings
- Kidney Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
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).
Measured: At baseline and then at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma US, Inc.
- Responsible party
- Principal investigator, Amira Al-Uzri, Oregon Health and Science University
- Investigators
- Amira Al-Uzri, MD, MCR, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01931397
- Sponsor's protocol ID
- PROG-12G03
- Acronym
- DBS
- Status last verified
- Mar 2017
- First submitted
- 16 Aug 2013
- Last updated
- 17 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Use of Dried Blood Spots (DBS)for Home Monitoring in Children With Kidney
- ClinicalTrials.gov ID
- NCT01931397
- Acronym / sponsor ID
- DBS / PROG-12G03
- Conditions
- Kidney Disease
- Keywords
- Dried blood spots, kidney transplant, Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Astellas Pharma US, Inc.
- Study start
- Jul 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 29 Aug 2013 (estimated)
- Results
- Posted 17 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- On Tacrolimus immunosuppression therapy
- At least six months post kidney transplantation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- children who are followed at the Pediatric Kidney Transplant CLinic at OHSU.
Key inclusion criteria (3 listed)
- Kidney transplant recipients between the ages of 2-21 years at time of enrollment
- On Tacrolimus immunosuppression therapy
- At least six months post kidney transplantation
Key exclusion criteria (1 listed)
- Not on tacrolimus therapy Less than 6 months after kidney transplantation Refusal to provide consent fomr
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Variability of Tacrolimus Blood Levels Measured by DBS Over Time
Time frame: 12 months
Mean standard deviation scores for Tacrolimus blood levels obtained by DBS for each patient over time.
1 secondary outcome
Percentage of Families Preferring DBS Method
Time frame: At baseline and then at 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Kidney Disease
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amira Al-Uzri, MD, MCR principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Disease, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variability of Tacrolimus Blood Levels Measured by DBS Over Time (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2017.