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NCT05005221 · ClinicalTrials.gov registry record · NA
Home-based Therapeutic Drug Monitoring in Kidney Transplantation
A NA study, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 41
- Enrollment target
NCT05005221: Completed NA study, sponsored by University of Michigan.
NCT05005221 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 41 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05005221, a NA study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 41 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- BEHAVIORAL Automated text messages
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2022-11-08 |
| Est. Completion | 2024-05-08 |
| Phase | NA |
What the finished NCT05005221 record still lists
NCT05005221 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Automated text messages is the first listed.
NCT05005221 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05005221 about?
NCT05005221 is a clinical study titled "Home-based Therapeutic Drug Monitoring in Kidney Transplantation". 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 k...
What is the current status of trial NCT05005221?
This trial is currently completed. It is a NA study. The enrollment target is 41 participants. The study started on 2022-11-08. Estimated completion is 2024-05-08.
What interventions are being tested in trial NCT05005221?
The interventions under investigation include: Automated text messages (BEHAVIORAL).
Who is sponsoring clinical trial NCT05005221?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05005221's enrollment target sits among peer trials
41 1446th of 2000 higher than 554 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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