Status:
COMPLETED
Assessment of Cognitive Function Before and After Conversion From Immediate Release Tacrolimus to Envarsus XR.
Lead Sponsor:
Yale University
Collaborating Sponsors:
Veloxis Pharmaceuticals
Conditions:
Kidney Transplant; Complications
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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 objecti...
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 as...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2024
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03410654
Start Date
October 24 2018
End Date
July 1 2024
Last Update
August 21 2024
Active Locations (1)
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1
Yale New Haven Transplantation Center
New Haven, Connecticut, United States, 06520