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OpenTrials
Completed

NCT Number: NCT03410654

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.

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Key information

Conditions

Kidney Transplant; Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Yale New Haven Transplantation Center

New Haven, Connecticut, 06520, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tacrolimus, Extended Release, (Envarsus Xr)

Drug

After conversion of tacrolimus immediate release to tacrolimus extended release.

Other names: Envarsus XR® (TAC XR)

Primary outcomes

  1. cognitive assessment at baseline

    Time frame: baseline

    cognitive assessment at baseline using MoCA test 7.1

  2. cognitive improvement from baseline

    Time frame: 3 months after enrollment

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

Secondary outcomes

  1. MoCA cognitive assessment

    Time frame: 3 months after enrollment

    cognitive assessment using MoCA 7.2

  2. NIH Toolbox cognitive test

    Time frame: baseline

    NIH Toolbox Flanker Inhibitory Control and Attention Test

  3. NIH Toolbox cognitive test

    Time frame: 3 months

    NIH Toolbox Flanker Inhibitory Control and Attention Test

  4. NIH Toolbox cognitive test

    Time frame: baseline

    NIH Toolbox Dimensional Change Card Sort Test

  5. NIH Toolbox cognitive test

    Time frame: 3 months

    NIH Toolbox Dimensional Change Card Sort Test

  6. NIH Toolbox cognitive test

    Time frame: baseline

    NIH Toolbox Picture Sequence Memory Test Version A

  7. NIH Toolbox cognitive test

    Time frame: 3 months

    NIH Toolbox Picture Sequence Memory Test Version B

  8. NIH Toolbox cognitive test

    Time frame: baseline

    NIH Toolbox Pattern Comparison Processing Speed Test

  9. NIH Toolbox cognitive test

    Time frame: 3 months

    NIH Toolbox Pattern Comparison Processing Speed Test

  10. NIH Toolbox cognitive test

    Time frame: baseline

    NIH Toolbox List Sorting Working Memory Test

  11. NIH Toolbox cognitive test

    Time frame: 3 months

    NIH Toolbox List Sorting Working Memory Test

  12. NIH Toolbox cognitive test

    Time frame: baseline

    NIH Toolbox Reading Recognition Test

  13. NIH Toolbox cognitive test

    Time frame: 3 months

    NIH Toolbox Reading Recognition Test

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Veloxis Pharmaceuticals

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Jan 25, 2018
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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