Assessment of Cognitive Function Before and After Conversion From Immediate Release Tacrolimus to Envarsus XR.
- Conditions
- Kidney TransplantComplications
- Registration Number
- NCT03410654
- Lead Sponsor
- Yale University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Post-renal transplant on stable TAC IR for at least 6 months who are converting to<br> TAC XR regardless of indication.<br><br> - Patients receiving their post-transplant care through the Yale-New Haven<br> Transplantation Center (YNHTC) regardless of where they were originally<br> transplanted.<br><br>Exclusion Criteria:<br><br> - History of dementia or stroke<br><br> - Reside in a nursing home<br><br> - Newly started on an opiate, amphetamine, or benzodiazepine<br><br> - Non-English speaking (due to lack of NIH toolbox assessments in other languages)<br><br> - Patients that exhibit signs of acute infection, hemodynamic compromise or other<br> signs of critical illness (e.g. respiratory distress requiring mechanical<br> ventilation)<br><br> - Recipients of a multiorgan transplant<br><br> - Pregnant women<br><br> - Transplant recipients unable to provide informed consent to participate in this<br> research
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method cognitive assessment at baseline;cognitive improvement from baseline
- Secondary Outcome Measures
Name Time Method MoCA cognitive assessment;NIH Toolbox cognitive test;NIH Toolbox cognitive test;NIH Toolbox cognitive test;NIH Toolbox cognitive test;NIH Toolbox cognitive test;NIH Toolbox cognitive test;NIH Toolbox cognitive test;NIH Toolbox cognitive test;NIH Toolbox cognitive test;NIH Toolbox cognitive test;NIH Toolbox cognitive test;NIH Toolbox cognitive test