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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Kidney Transplant; Complications

Intervention / Treatment
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* Drug: Tacrolimus, Extended Release, (Envarsus Xr)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: adult kidney transplant recipients<br>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. | Drug: Tacrolimus, Extended Release, (Envarsus Xr)<br>* After conversion of tacrolimus immediate release to tacrolimus extended release.<br>* Other names: Envarsus XR® (TAC XR);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cognitive assessment at baseline | cognitive assessment at baseline using MoCA test 7.1 | baseline | 
| cognitive improvement from baseline | cognitive evaluation from baseline average for adults using NIH Toolbox Cognitive Domain | 3 months after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MoCA cognitive assessment | cognitive assessment using MoCA 7.2 | 3 months after enrollment | 
| NIH Toolbox cognitive test | NIH Toolbox Flanker Inhibitory Control and Attention Test | baseline | 
| NIH Toolbox cognitive test | NIH Toolbox Flanker Inhibitory Control and Attention Test | 3 months | 
| NIH Toolbox cognitive test | NIH Toolbox Dimensional Change Card Sort Test | baseline | 
| NIH Toolbox cognitive test | NIH Toolbox Dimensional Change Card Sort Test | 3 months | 
| NIH Toolbox cognitive test | NIH Toolbox Picture Sequence Memory Test Version A | baseline | 
| NIH Toolbox cognitive test | NIH Toolbox Picture Sequence Memory Test Version B | 3 months | 
| NIH Toolbox cognitive test | NIH Toolbox Pattern Comparison Processing Speed Test | baseline | 
| NIH Toolbox cognitive test | NIH Toolbox Pattern Comparison Processing Speed Test | 3 months | 
| NIH Toolbox cognitive test | NIH Toolbox List Sorting Working Memory Test | baseline | 
| NIH Toolbox cognitive test | NIH Toolbox List Sorting Working Memory Test | 3 months | 
| NIH Toolbox cognitive test | NIH Toolbox Reading Recognition Test | baseline | 
| NIH Toolbox cognitive test | NIH Toolbox Reading Recognition Test | 3 months |