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DBS for Home Monitoring in Children With Kidney Transplantation
NCT01931397 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Study Locations (1)
Oregon
- Doernbecher Children's Hospital /OHSU — Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2013-07 |
| Est. Completion | 2015-02 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01931397
The ClinicalTrials.gov registry entry for NCT01931397 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oregon Health and Science University, which has 665 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Kidney Disease appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01931397 reports 1 study location spanning 1 distinct geographic area — top geographies include Oregon. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01931397 about?
NCT01931397 is a clinical study titled "DBS for Home Monitoring in Children With Kidney Transplantation". 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 r...
What is the current status of trial NCT01931397?
This trial is currently completed. The enrollment target is 30 participants. The study started on 2013-07. Estimated completion is 2015-02.
What conditions does trial NCT01931397 study?
This clinical trial studies the following conditions: Kidney Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT01931397?
This trial is sponsored by Oregon Health and Science University, which has 665 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01931397 being conducted?
This trial has 1 study location across Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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