Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04838288
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-26
First Post:
2021-03-31
Brief Title:
Cognitive Outcomes in Stable Renal Transplant Patients Switched fromTacrolimus to Envarsus XR
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
Cognitive Outcomes and Quality of Life in Stable Renal Transplant Patients Switched fromTwice-Daily Tacrolimus to Envarsus XR
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPERATOR
Brief 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
Detailed Description:
Patients with chronic kidney disease most commonly show cognitive impairments involving attention memory executive functions and mental processing speed Although data have demonstrated improvements in cognition following kidney transplant and the reversibility of the memory problems evidenced in dialysis neurotoxicity in transplant patients occurs in 40-50 of the patients treated with tacrolimus Attention and working memory impairment have been observed in patients treated with sirolimus or tacrolimus while cyclosporine-treated patients demonstrated performance similar to that of healthy volunteer controls which may indicate that the cognitive deficit found was partly related to treatment ENVARSUS XR is a new FDA-approved formulation of tacrolimus A hallmark difference between ENVARSUS XR and other forms of once- and twice-daily tacrolimus products is the unique proprietary MeltDose drug delivery technology Veloxis Pharmaceuticals Hørsholm Denmark which reduces tacrolimus particle size to a molecular level The decreased surface area of the drug particles results in complete absorption and increased bioavailability in a once-daily dosing formulation In stable kidney transplant patients ENVARSUS XR pharmacokinetics are characterized by a steadier and more consistent concentration time profile over 24 hours reduced peak and peak-to-trough fluctuations and similar exposure while benefiting from 20 less total daily dose than twice daily tacrolimus This open-label prospective phase clinical trial is designed to evaluate whether switching patients from TAC-IR to ENVARSUS XR treatment improves cognitive function
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None