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NCT04156204 · ClinicalTrials.gov registry record · Early Phase 1
Immunosuppressant Medication Dosed Daily After Kidney Transplant
A Early Phase 1 study, sponsored by University of Colorado, Denver.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 1
- Enrollment target
NCT04156204 is a Early Phase 1 study that was terminated before completion, run by University of Colorado, Denver. The registered enrollment target is 1 participants.
The verdict
NCT04156204, a Early Phase 1 study, was terminated before completion, sponsored by University of Colorado, Denver.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
Medication non-adherence is a major risk factor for graft dysfunction and graft loss among pediatric and adult transplant recipients. Rates of non-adherence in these populations are estimated between 30 and 70%, with the highest prevalence in adolescent and young adult (AYA) transplant recipients. Treatment-related factors known to impact rates of adherence include the number of medication doses per day and the number of tablets or capsules a patient takes per day, or "pill burden". One approach to minimizing dosing frequency and pill-burden includes transitioning patients to once-daily formulations. The current literature investigating utilization of once-daily immunosuppressive regimens in the AYA kidney transplant population is limited.
Interventions
- OTHER Medication Event Monitoring System (MEMS)
- DRUG Once-Daily Tacrolimus extended release
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2019-11-20 |
| Est. Completion | 2020-11-27 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04156204
The ClinicalTrials.gov registry entry for NCT04156204 describes a study currently listed as terminated, categorized as Early Phase 1. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Medication Event Monitoring System (MEMS) is the first listed.
NCT04156204 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04156204 about?
NCT04156204 is a clinical study titled "Immunosuppressant Medication Dosed Daily After Kidney Transplant". Medication non-adherence is a major risk factor for graft dysfunction and graft loss among pediatric and adult transplant recipients. Rates of non-adherence in these populations are estimated between 30 and 70%, with the highest prevalence in adolescent and young adult (AYA) transplant recipients. T...
What is the current status of trial NCT04156204?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 1 participants. The study started on 2019-11-20. Estimated completion is 2020-11-27.
What interventions are being tested in trial NCT04156204?
The interventions under investigation include: Medication Event Monitoring System (MEMS) (OTHER), Once-Daily Tacrolimus extended release (DRUG).
Who is sponsoring clinical trial NCT04156204?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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