Home-based Therapeutic Drug Monitoring in Kidney Transplantation

NCT ID: NCT05005221

Last Updated: 2025-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-08
• Study Completion Date: 2024-05-08

Brief 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.

Detailed 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).

Conditions

Kidney Transplant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Unidirectional Text Reminders

Participants in the unidirectional text reminder arm will receive automated text messages to remind them to collect blood samples 48 hours before, 12 hours before, and the morning of the planned sample collection.

N=15

Group Type: ACTIVE_COMPARATOR

Automated text messages

Intervention Type: BEHAVIORAL

Automated text messages will be used to facilitate blood sample collection at home for therapeutic drug monitoring of tacrolimus and mycophenolate. Participants will collect dried blood samples on 4 occasions. Two days in the clinical with simultaneous venipuncture (one sample) and two days at home with 4 samples collected at specified time points over 8 hours.

Bidirectional Text Communication

Participants in the bidirectional text communication arm will also receive automated messages to remind them to collect blood samples 48 hours before, 12 hours before, and the morning of the planned sample collection but they will be asked to confirm the planned day or reschedule. On the day of sample collection participants will also reply with the time the samples are collected to trigger future reminder messages for each of the 4 samples.

N=30

Group Type: EXPERIMENTAL

Automated text messages

Intervention Type: BEHAVIORAL

Automated text messages will be used to facilitate blood sample collection at home for therapeutic drug monitoring of tacrolimus and mycophenolate. Participants will collect dried blood samples on 4 occasions. Two days in the clinical with simultaneous venipuncture (one sample) and two days at home with 4 samples collected at specified time points over 8 hours.

Interventions

Automated text messages

Automated text messages will be used to facilitate blood sample collection at home for therapeutic drug monitoring of tacrolimus and mycophenolate. Participants will collect dried blood samples on 4 occasions. Two days in the clinical with simultaneous venipuncture (one sample) and two days at home with 4 samples collected at specified time points over 8 hours.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Recipient of a kidney or kidney/pancreas transplant
• Receiving immediate-release tacrolimus and mycophenolate mofetil
• Willing to received text messages with a mobile device capable of receiving messages
• Willing to receive standard labs at a Michigan Medicine lab draw site on 2 occasions
• Ability to understand, read, and speak English
• Ability to understand and willingness to sign written informed consent

Exclusion Criteria

• History of multi-organ transplant (other than pancreas)
• History of allergy to tape adhesives

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Manjunath Prakash Pai

Professor of Clinical Pharmacy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HUM00198148

Identifier Type: -

Identifier Source: org_study_id