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

Yale University

Status and phase: Completed; Early Phase 1

Conditions: Kidney Transplant; Complications

Treatments: Drug: Tacrolimus, Extended Release, (Envarsus Xr)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03410654

000

2000022307

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

adult kidney transplant recipients

Experimental group

Description:

Adult kidney transplant recipients on tacrolimus immediate release for at least six months who are being converted to tacrolimus extended release Envarsus XR® (TAC XR) for any reason by a transplant nephrologist and are willing to participate in cognitive assessment will be offered the opportunity to participate in the study. An assessment is also made at the 3 month point as baseline.

Treatment:

Drug: Tacrolimus, Extended Release, (Envarsus Xr)