Kidney Transplant; Complications
Conditions
Brief summary
The purpose of this study is to determine if cognitive function improves in patients converted from tacrolimus immediate release (TAC IR) to Envarsus XR® (tacrolimus extended release) using an objective measure of cognition.
Detailed description
To assess cognitive function while on TAC IR and then three months after conversion to TAC XR using a traditional cognitive assessment, Montreal Cognitive Assessment (MoCA), and a broader cognitive assessment. This assessment will be used to determine if there is an objective improvement in cognitive function after conversion from TAC IR to TAC XR in kidney transplant recipients.
Interventions
DRUGTacrolimus, Extended Release, (Envarsus Xr)
After conversion of tacrolimus immediate release to tacrolimus extended release.
Sponsors
Veloxis Pharmaceuticals
Yale University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Post-renal transplant on stable TAC IR for at least 6 months who are converting to TAC XR regardless of indication. * Patients receiving their post-transplant care through the Yale-New Haven Transplantation Center (YNHTC) regardless of where they were originally transplanted.
Exclusion criteria
* History of dementia or stroke * Reside in a nursing home * Newly started on an opiate, amphetamine, or benzodiazepine * Non-English speaking (due to lack of NIH toolbox assessments in other languages) * Patients that exhibit signs of acute infection, hemodynamic compromise or other signs of critical illness (e.g. respiratory distress requiring mechanical ventilation) * Recipients of a multiorgan transplant * Pregnant women * Transplant recipients unable to provide informed consent to participate in this research
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cognitive assessment at baseline | baseline | cognitive assessment at baseline using MoCA test 7.1 |
| cognitive improvement from baseline | 3 months after enrollment | cognitive evaluation from baseline average for adults using NIH Toolbox Cognitive Domain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MoCA cognitive assessment | 3 months after enrollment | cognitive assessment using MoCA 7.2 |
| NIH Toolbox cognitive test | baseline | NIH Toolbox Flanker Inhibitory Control and Attention Test |
Countries
United States
Outcome results
None listed