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NCT04838288 · ClinicalTrials.gov registry record · Phase 4
Cognitive Outcomes in Stable Renal Transplant Patients Switched FromTacrolimus to Envarsus XR™
A Phase 4 study of Renal Transplant, sponsored by Vanderbilt University Medical Center.
- Active
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT04838288: Active Phase 4 study of Renal Transplant, sponsored by Vanderbilt University Medical Center.
NCT04838288 is a Phase 4 study of Renal Transplant that is active but no longer recruiting, run by Vanderbilt University Medical Center. The registered enrollment target is 60 participants, above the 40-participant average among 5 other Renal Transplant trials with a reported enrollment target (50% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04838288, a Phase 4 study of Renal Transplant, is active but no longer recruiting, sponsored by Vanderbilt University Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to assess cognitive outcome and quality of life in stable renal transplant patients treated with twice daily tacrolimus at baseline and after switching to Envarsus XL. The study is designed to see if switching patients from Tacrolimus to Envarsus treatment improves cognitive function.
Primary Outcome
Due to safety precautions for COVID-19 precluding us from seeing patients in person, neurocognitive function was assessed via a phone battery derived from standard cognitive tests and proven feasible and valid to assess memory, attention, reasoning, and executive function, including TICS (Telephone interview for Cognitive Testing: Scale of 0-41, \<26= mild cognitive impairment), WAIS-IV (Digit Span and Similarities: Scale of 1-19, \<=6 impairment), WMS-IV (Logical Memory Subsets I \& II: Scale o
Conditions Studied
Interventions
- DRUG Change from Prograf to Envarsus XR
Study Locations (1)
Tennessee
- VUMC - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2021-06-22 |
| Est. Completion | 2026-01-31 |
| Phase | Phase 4 |
What the registry record for NCT04838288 still lists
NCT04838288 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, above the 40-participant average among 5 other Renal Transplant trials with a reported enrollment target (50% higher).
The record links to 1 condition, with Renal Transplant appearing as the primary indexed condition, and to 1 intervention - of which Change from Prograf to Envarsus XR is the first listed.
NCT04838288 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT04838288 about?
NCT04838288 is a clinical study titled "Cognitive Outcomes in Stable Renal Transplant Patients Switched FromTacrolimus to Envarsus XR™". The purpose of this study is to assess cognitive outcome and quality of life in stable renal transplant patients treated with twice daily tacrolimus at baseline and after switching to Envarsus XL. The study is designed to see if switching patients from Tacrolimus to Envarsus treatment improves cogni...
What is the current status of trial NCT04838288?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2021-06-22. Estimated completion is 2026-01-31.
What conditions does trial NCT04838288 study?
This clinical trial studies the following conditions: Renal Transplant.
What interventions are being tested in trial NCT04838288?
The interventions under investigation include: Change from Prograf to Envarsus XR (DRUG).
Who is sponsoring clinical trial NCT04838288?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04838288 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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