Home-based Therapeutic Drug Monitoring in Kidney Transplantation

NCT05005221 | Completed Results

• 1 other identifier: HUM00198148
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplant

Keywords

Tacrolimus; Mycophenolate; Therapeutic Drug Monitoring

Outcome Measures

Primary Outcomes (1)

• Percent of Samples Successfully Returned for Drug Monitoring by Participants in the Unidirectional and Bidirectional Arms

  Successful home-based therapeutic drug monitoring is defined as a binary composite of 1) timely receipt (postmarked within 48 hours of planned sample collection) of samples and 2) adequate documentation of sample collection time data for pharmacokinetic analysis. Each participant in the Unidirectional and Bidirectional Text Communication arms had two opportunities for sample collection. Participants in the third arm for bioanalytical validation did not complete home sample collection and do not have results for this outcome measure.

  3 months

Secondary Outcomes (2)

• Percent of Paired Samples With </=15% Difference Between Tacrolimus Concentrations Obtained Via Dried Blood and Venipuncture in the Analytical Validation Arm

  2 days

• Percent of Paired Samples With </=15% Difference Between Mycophenolic Acid Concentrations Obtained Via Dried Blood and Venipuncture in the Analytical Validation Arm

  2 days

Study Arms (2)

Unidirectional Text Reminders

ACTIVE COMPARATOR

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

Behavioral: Automated text messages

Bidirectional Text Communication

EXPERIMENTAL

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

Behavioral: Automated text messages

Interventions

Automated text messages 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; Unidirectional Text Reminders

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Results Point of Contact

• Title: Manjunath Pai
• Organization: University of Michigan

amitpai@med.umich.edu

734/647-0006

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Pharmacy

Model Details: Participants will be randomized in a 1:2 allocation ratio to receive one of two text messaging interventions (basic text message reminders or more intensive bidirectional messages).

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: August 13, 2021
• Study Start: November 8, 2022
• Primary Completion: May 6, 2024
• Study Completion: May 8, 2024
• Last Updated: February 27, 2025
• Results First Posted: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)