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NCT03461445 · ClinicalTrials.gov registry record · Phase 4
Effect of Tacrolimus Formulation on Neurological Side Effects in Older Kidney Transplant Recipients
A Phase 4 study, sponsored by University of California, Davis.
- Completed
- Registry status
- Phase 4
- Development phase
- 64
- Enrollment target
NCT03461445: Completed Phase 4 study, sponsored by University of California, Davis.
NCT03461445 is a Phase 4 study that has completed, run by University of California, Davis. The registered enrollment target is 64 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03461445, a Phase 4 study, has completed, sponsored by University of California, Davis.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 64 participants
- Enrollment target
Study Summary
Previous studies have shown that elderly patients experience higher trough levels of tacrolimus and are more sensitive to the effects of medications, they experience higher occurrence and severity of such medication related toxicities. Therefore, the investigators hypothesize that by transitioning patients from tacrolimus immediate release to Envarsus ®, the peak-dose effect will be eliminated or attenuated, leading to a significant decrease in neurocognitive toxicities in the older patient population.
Primary Outcome
Change in MOCA (Montreal Cognitive Assessment) from baseline to study end. MOCA scale runs from 0 to 30 with higher being a better outcome. Change in DSST (Digital Symbol Substitution Test) from baseline to study end. DSST scale runs from 1 to 125 with higher being a better outcome.
Interventions
- DRUG Envarsus
- DRUG IR Tacrolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2018-04-01 |
| Est. Completion | 2023-07-31 |
| Phase | Phase 4 |
What the finished NCT03461445 record still lists
NCT03461445 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Envarsus is the first listed.
NCT03461445 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03461445 about?
NCT03461445 is a clinical study titled "Effect of Tacrolimus Formulation on Neurological Side Effects in Older Kidney Transplant Recipients". Previous studies have shown that elderly patients experience higher trough levels of tacrolimus and are more sensitive to the effects of medications, they experience higher occurrence and severity of such medication related toxicities. Therefore, the investigators hypothesize that by transitioning p...
What is the current status of trial NCT03461445?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 64 participants. The study started on 2018-04-01. Estimated completion is 2023-07-31.
What interventions are being tested in trial NCT03461445?
The interventions under investigation include: Envarsus (DRUG), IR Tacrolimus (DRUG).
Who is sponsoring clinical trial NCT03461445?
This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03461445's enrollment target sits among peer trials
64 1098th of 2000 higher than 895 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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