Assessment of Cognitive Function Before and After Conversion From Immediate Release Tacrolimus to Envarsus XR
Overview
- Phase
- Early Phase 1
- Intervention
- Tacrolimus, Extended Release, (Envarsus Xr)
- Conditions
- Kidney Transplant; Complications
- Sponsor
- Yale University
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- cognitive assessment at baseline
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
adult kidney transplant recipients
Adult kidney transplant recipients on tacrolimus immediate release for at least six months who are being converted to tacrolimus extended release Envarsus XR® (TAC XR) for any reason by a transplant nephrologist and are willing to participate in cognitive assessment will be offered the opportunity to participate in the study. An assessment is also made at the 3 month point as baseline.
Intervention: Tacrolimus, Extended Release, (Envarsus Xr)
Outcomes
Primary Outcomes
cognitive assessment at baseline
Time Frame: baseline
cognitive assessment at baseline using MoCA test 7.1
cognitive improvement from baseline
Time Frame: 3 months after enrollment
cognitive evaluation from baseline average for adults using NIH Toolbox Cognitive Domain
Secondary Outcomes
- NIH Toolbox cognitive test(3 months)
- MoCA cognitive assessment(3 months after enrollment)