Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT01931397 · ClinicalTrials.gov registry record

DBS for Home Monitoring in Children With Kidney Transplantation

A clinical trial of Kidney Disease, sponsored by Oregon Health and Science University.

Completed
Registry status
30
Enrollment target
1
Study location

NCT01931397 is a study of Kidney Disease that has completed, run by Oregon Health and Science University. The registered enrollment target is 30 participants, below the 2,939-participant average among 23 other Kidney Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT01931397, a study of Kidney Disease, has completed, sponsored by Oregon Health and Science University.

COMPLETED
Registry status
30 participants
Enrollment target
1
Study location

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

FieldValue
Enrollment Target 30 participants
Start Date 2013-07
Est. Completion 2015-02

What the Registry Record Tells You About NCT01931397

The ClinicalTrials.gov registry entry for NCT01931397 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,939-participant average among 23 other Kidney Disease trials with a reported enrollment target (99% lower). The listed sponsor is Oregon Health and Science University, which has 546 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Kidney Disease appearing as the primary indexed condition, and to 0 interventions.

NCT01931397 reports 1 study location spanning 1 distinct geographic area - top geographies include Oregon.

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.

Who is sponsoring clinical trial NCT01931397?

This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.

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.

Similar trials for Kidney Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.