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

March 1, 2024 updated by: Yale University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

35

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Tacrolimus, Extended Release, (Envarsus Xr)
After conversion of tacrolimus immediate release to tacrolimus extended release.
Other Names:
  • Envarsus XR® (TAC XR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cognitive assessment at baseline
Time Frame: baseline
cognitive assessment at baseline using MoCA test 7.1
baseline
cognitive improvement from baseline
Time Frame: 3 months after enrollment
cognitive evaluation from baseline average for adults using NIH Toolbox Cognitive Domain
3 months after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MoCA cognitive assessment
Time Frame: 3 months after enrollment
cognitive assessment using MoCA 7.2
3 months after enrollment
NIH Toolbox cognitive test
Time Frame: baseline
NIH Toolbox Flanker Inhibitory Control and Attention Test
baseline
NIH Toolbox cognitive test
Time Frame: 3 months
NIH Toolbox Flanker Inhibitory Control and Attention Test
3 months
NIH Toolbox cognitive test
Time Frame: baseline
NIH Toolbox Dimensional Change Card Sort Test
baseline
NIH Toolbox cognitive test
Time Frame: 3 months
NIH Toolbox Dimensional Change Card Sort Test
3 months
NIH Toolbox cognitive test
Time Frame: baseline
NIH Toolbox Picture Sequence Memory Test Version A
baseline
NIH Toolbox cognitive test
Time Frame: 3 months
NIH Toolbox Picture Sequence Memory Test Version B
3 months
NIH Toolbox cognitive test
Time Frame: baseline
NIH Toolbox Pattern Comparison Processing Speed Test
baseline
NIH Toolbox cognitive test
Time Frame: 3 months
NIH Toolbox Pattern Comparison Processing Speed Test
3 months
NIH Toolbox cognitive test
Time Frame: baseline
NIH Toolbox List Sorting Working Memory Test
baseline
NIH Toolbox cognitive test
Time Frame: 3 months
NIH Toolbox List Sorting Working Memory Test
3 months
NIH Toolbox cognitive test
Time Frame: baseline
NIH Toolbox Reading Recognition Test
baseline
NIH Toolbox cognitive test
Time Frame: 3 months
NIH Toolbox Reading Recognition Test
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

Veloxis Pharmaceuticals

Investigators

  • Principal Investigator: Elizabeth Cohen, PharmD, Yale New Haven Hospital
  • Principal Investigator: Richard Formica, MD, Yale Univeristy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2018

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

January 10, 2018

First Submitted That Met QC Criteria

January 18, 2018

First Posted (Actual)

January 25, 2018

Study Record Updates

Last Update Posted (Actual)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000022307
  • 000 (Other Identifier: CTGTY)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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