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

NCT03410654 | Completed Early Phase 1 FDA Drug

• 2 other identifiers: 2000022307000
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplant; Complications

Outcome Measures

Primary Outcomes (2)

• cognitive assessment at baseline

  cognitive assessment at baseline using MoCA test 7.1

  baseline

• cognitive improvement from baseline

  cognitive evaluation from baseline average for adults using NIH Toolbox Cognitive Domain

  3 months after enrollment

Secondary Outcomes (13)

• MoCA cognitive assessment

  3 months after enrollment

• NIH Toolbox cognitive test

  baseline

• NIH Toolbox cognitive test

  3 months

• NIH Toolbox cognitive test

  baseline

• NIH Toolbox cognitive test

  3 months

Study Arms (1)

adult kidney transplant recipients

EXPERIMENTAL

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.

Drug: Tacrolimus, Extended Release, (Envarsus Xr)

Interventions

Tacrolimus, Extended Release, (Envarsus Xr) DRUG

After conversion of tacrolimus immediate release to tacrolimus extended release.

Also known as: Envarsus XR® (TAC XR)

adult kidney transplant recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• Veloxis Pharmaceuticals: collaborator

Study Sites (1)

Yale New Haven Transplantation Center

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Elizabeth Cohen, PharmD

  Yale New Haven Hospital

  PRINCIPAL INVESTIGATOR

• Richard Formica, MD

  Yale Univeristy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: January 25, 2018
• Study Start: October 24, 2018
• Primary Completion: January 1, 2024
• Study Completion: July 1, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

US (1)