Trial Outcomes & Findings for Home-based Therapeutic Drug Monitoring in Kidney Transplantation (NCT NCT05005221)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

41 participants

Primary outcome timeframe

3 months

Results posted on

2025-02-27

Participant Flow

Participant milestones

Participant milestones
Measure	Unidirectional Text Reminders Participants in the unidirectional text reminder arm received automated text messages to remind them to collect blood samples 48 hours before, 12 hours before, and the morning of the planned sample collection.	Bidirectional Text Communication Participants in the bidirectional text communication arm received 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 were asked to confirm the planned day or reschedule. On the day of sample collection participants also replied with the time the samples are collected to trigger future reminder messages for each of the 4 samples.	Analytical Validation Participants in analytical validation group provided paired dried and venous blood.
Overall Study STARTED	5	9	27
Overall Study COMPLETED	5	9	25
Overall Study NOT COMPLETED	0	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Unidirectional Text Reminders n=5 Participants Participants in the unidirectional text reminder arm received automated text messages to remind them to collect blood samples 48 hours before, 12 hours before, and the morning of the planned sample collection.	Bidirectional Text Communication n=9 Participants Participants in the bidirectional text communication arm received 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 were asked to confirm the planned day or reschedule. On the day of sample collection participants also replied with the time the samples are collected to trigger future reminder messages for each of the 4 samples.	Analytical Validation n=25 Participants Participants in analytical validation group provided paired dried and venous blood.	Total n=39 Participants Total of all reporting groups
Age, Continuous	52.6 years STANDARD_DEVIATION 10.2 • n=5 Participants	52.3 years STANDARD_DEVIATION 8.8 • n=9 Participants	54 years STANDARD_DEVIATION 14.4 • n=25 Participants	53.8 years STANDARD_DEVIATION 12.5 • n=39 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=9 Participants	6 Participants n=25 Participants	12 Participants n=39 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	5 Participants n=9 Participants	19 Participants n=25 Participants	27 Participants n=39 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	5 participants n=5 Participants	9 participants n=9 Participants	25 participants n=25 Participants	39 participants n=39 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Participants in Unidirectional and Bidirectional text communication 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.

Outcome measures

Outcome measures
Measure	Unidirectional Text Reminders n=10 samples 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.	Bidirectional Text Communication n=18 samples 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.
Percent of Samples Successfully Returned for Drug Monitoring by Participants in the Unidirectional and Bidirectional Arms	83 % of samples postmarked with 48 hrs	100 % of samples postmarked with 48 hrs

SECONDARY outcome

Timeframe: 2 days

Population: Participants from the analytical validation arm

Compare concentrations of tacrolimus obtained using the two sample collection methods (dried blood and venipuncture) as measured by liquid chromatography with tandem mass spectrometry (LC-MS/MS). Each participant in the analytical validation arm provided two sets of paired samples on different days.

Outcome measures

Outcome measures
Measure	Unidirectional Text Reminders n=50 sample pairs 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.	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.
Percent of Paired Samples With </=15% Difference Between Tacrolimus Concentrations Obtained Via Dried Blood and Venipuncture in the Analytical Validation Arm	80 % of pairs with %difference </=15%	—

SECONDARY outcome

Timeframe: 2 days

Population: Participants from the analytical validation arm

Compare concentrations of mycophenolic acid obtained using the two sample collection methods (dried blood and venipuncture) as measured by liquid chromatography with tandem mass spectrometry (LC-MS/MS). Each participant in the analytical validation arm provided two sets of paired samples on different days.

Outcome measures

Outcome measures
Measure	Unidirectional Text Reminders n=50 sample pairs 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.	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.
Percent of Paired Samples With </=15% Difference Between Mycophenolic Acid Concentrations Obtained Via Dried Blood and Venipuncture in the Analytical Validation Arm	76 % of pairs with %difference </=15%	—

Adverse Events

Unidirectional Text Reminders

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bidirectional Text Communication

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Analytical Validation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Manjunath Pai

University of Michigan

Phone: 734/647-0006

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place