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

• Status: Recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Treatments: Tacrolimus

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