NCT03410654

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

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Transplant; Complications

Interventions

Type	Name	Description
DRUG	Tacrolimus, Extended Release, (Envarsus Xr)	After conversion of tacrolimus immediate release to tacrolimus extended release.

Timeline

• Start date: 2018-10-24
• Primary completion: 2024-01-01
• Completion: 2024-07-01
• First posted: 2018-01-25
• Last updated: 2024-08-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study