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

NCT ID: NCT03410654

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-24
• Study Completion Date: 2024-07-01

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 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

adult kidney transplant recipients

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.

Group Type: EXPERIMENTAL

Tacrolimus, Extended Release, (Envarsus Xr)

Intervention Type: DRUG

After conversion of tacrolimus immediate release to tacrolimus extended release.

Interventions

Tacrolimus, Extended Release, (Envarsus Xr)

After conversion of tacrolimus immediate release to tacrolimus extended release.

Intervention Type: DRUG

Other Intervention Names

Envarsus XR® (TAC XR)

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Veloxis Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elizabeth Cohen, PharmD

Role: PRINCIPAL_INVESTIGATOR

Yale New Haven Hospital

Richard Formica, MD

Role: PRINCIPAL_INVESTIGATOR

Yale Univeristy

Locations

Yale New Haven Transplantation Center

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

000

Identifier Type: OTHER

Identifier Source: secondary_id

2000022307

Identifier Type: -

Identifier Source: org_study_id