Assessment of Cognitive Function Before and After Conversion From Immediate Release Tacrolimus to Envarsus XR.



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:11/4/2018
Start Date:October 24, 2018
End Date:February 2020
Contact:Elizabeth Cohen, PharmD
Email:elizabeth.cohen@ynhh.org
Phone:203-688-1841

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Assessment of Cognitive Function Before and After Conversion From Immediate Release Tacrolimus to Envarsus XR

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.

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.

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
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