Clinical trial NCT03410654: Assessment of Cognitive Function Before and After Conversion From Immediate Release Tacrolimus to Envarsus XR.
Official title: Assessment of Cognitive Function Before and After Conversion From Immediate Release Tacrolimus to Envarsus XR
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Kidney Transplant; Complications
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Veloxis Pharmaceuticals
First posted: 2018-01-25
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: cognitive assessment at baseline
timeFrame: baseline
measure: cognitive improvement from baseline
timeFrame: 3 months after enrollment
Secondary outcomes:
measure: MoCA cognitive assessment
timeFrame: 3 months after enrollment
measure: NIH Toolbox cognitive test
timeFrame: baseline
measure: NIH Toolbox cognitive test
timeFrame: 3 months
measure: NIH Toolbox cognitive test
timeFrame: baseline
measure: NIH Toolbox cognitive test
timeFrame: 3 months
measure: NIH Toolbox cognitive test
timeFrame: baseline
measure: NIH Toolbox cognitive test
timeFrame: 3 months
measure: NIH Toolbox cognitive test
timeFrame: baseline
measure: NIH Toolbox cognitive test
timeFrame: 3 months
measure: NIH Toolbox cognitive test
timeFrame: baseline
measure: NIH Toolbox cognitive test
timeFrame: 3 months
measure: NIH Toolbox cognitive test
timeFrame: baseline
measure: NIH Toolbox cognitive test
timeFrame: 3 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Transplantation Center
state: Connecticut
Study officials:
affiliation: Yale New Haven Hospital
name: Elizabeth Cohen, PharmD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale Univeristy
name: Richard Formica, MD
role: PRINCIPAL_INVESTIGATOR
References: