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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: Clinical Trial Early Phase 1 study, sponsored by University of Colorado, Denver.
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, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Pediatric Quality of Life (PedsQL) Transplant Module Version 3.0 will be used to assess quality of life prior to and after transition from twice to once daily immunosuppressant medication regimen. Health-related quality of life (HRQOL) has been defined as an individual's subjective experience of their illness, and the impact that illness and its treatment have on the individual's functioning in a variety of domains. The PedsQL is a 46-item self- and parent-report measure that rates HRQOL in 8 do
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 |
Why NCT04156204 stopped before completion
NCT04156204 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Medication Event Monitoring System (MEMS) is the first listed.
NCT04156204 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04156204's enrollment target sits among peer trials
1 1985th of 2000 the lowest of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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