N/A Completed N=41 Randomized Health Services Research

Home-based Therapeutic Drug Monitoring in Kidney Transplantation

Source: ClinicalTrials.gov NCT05005221 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2025

Primary outcomePrimary: Percent of Samples Successfully Returned for Drug Monitoring by Participants in the Unidirectional and Bidirectional Arms — 83; 100 % of samples postmarked with 48 hrs

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent of Samples Successfully Returned for Drug Monitoring by Participants in the Unidirectional and Bidirectional Arms	83; 100	—
SECONDARY Percent of Paired Samples With </=15% Difference Between Tacrolimus Concentrations Obtained Via Dried Blood and Venipuncture in the Analytical Validation Arm	80	—
SECONDARY Percent of Paired Samples With </=15% Difference Between Mycophenolic Acid Concentrations Obtained Via Dried Blood and Venipuncture in the Analytical Validation Arm	76	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05005221). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.