Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05005221 |
| Other study ID # |
HUM00198148 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 8, 2022 |
| Est. completion date |
May 30, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
University of Michigan |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This is a randomized clinical trial to assess an intervention to facilitate patient
self-collection of dried blood samples at home for therapeutic drug monitoring of tacrolimus
and mycophenolate in kidney transplant recipients.
In this study, text messages will be sent to mobile devices to remind kidney transplant
recipients to perform therapeutic drug monitoring at home using a special lancet device to
collect blood samples from the upper arm. The primary objective is to evaluate if more
intensive, bidirectional text messages improve the quality of sample collection.
Description:
Optimal immunosuppression therapy, most commonly with tacrolimus and mycophenolate, is
critical for kidney transplantation success. While graft and patient survival are
multifaceted phenomena, they are commonly attributed to chronic, subclinical immune-mediated
damage, tacrolimus nephrotoxicity, or premature death secondary to complications amplified by
immunosuppression such as infection, malignancy, and cardiovascular disease. New approaches
are required to explore ways to optimize the precision dosing of immunosuppression to reduce
the associated significant long-term side effects with the potential to improve kidney
transplantation outcomes.
Currently, immunosuppressant dose adjustments empirically balance efficacy and toxicity in
conjunction with limited tacrolimus blood concentrations. However, both tacrolimus and
mycophenolate possess interpatient variability in drug exposure and response with
considerable overlap between therapeutic and adverse effects. Only tacrolimus is routinely
monitored as mycophenolate trough concentration is not correlated with drug exposure or
outcomes. The pharmacokinetic parameter area under the concentration-time curve (AUC) offers
a greater understanding of total drug exposure and has been associated with improved outcomes
for both tacrolimus and mycophenolate. Yet, AUC is not routinely determined because it is
impractical due to the need for multiple repeated samples in the clinic.
The investigators propose a prospective, single-center pilot study to evaluate the ability of
a text messaging intervention coupled with a novel lancet device, the Tasso-M20, to
facilitate the collection of dried blood samples by the patient at home for AUC estimation.
The goal of the project is to develop a patient-centric strategy to allow frequent,
longitudinal, minimally invasive sample collection which allows for more detailed assessments
of immunosuppression exposure.
The primary objective is to compare the effect of bidirectional text communication on
adherence to and accuracy of home-based AUC collection versus unidirectional text reminders
in kidney transplant recipients receiving tacrolimus and mycophenolate.
The secondary objective is to assess the bioanalytical agreement of two sample collection
methods (dried blood spot and venipuncture) as measured by Liquid Chromatography with tandem
mass spectrometry (LC-MS/MS).
