CompletedNCT03410654Updated Aug 21, 2024

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

An Early Phase 1 interventional study of Tacrolimus, Extended Release, (Envarsus Xr) in Kidney Transplant; Complications, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-21.

Sponsored by Yale University · Early Phase 1, Interventional, and Treatment

From the registry’s dates

Primary completion was Jan 2024, 2 years 9 months ago, and no results have been posted to the registry.

Phase: Early Phase 1
Study type: Interventional
Enrollment: 28
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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 studied

Kidney Transplant; Complications

In context

Lead sponsor

Yale University is the lead sponsor of 1,763 studies on the registry; 292 are open to participants now.

Of its 217 completed or terminated interventional studies of FDA-regulated products, 128 (59%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 design

Phase: Early Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 28 participants (actual)

Study arms

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)

Interventions

DrugTacrolimus, Extended Release, (Envarsus Xr)
After conversion of tacrolimus immediate release to tacrolimus extended release.
Also known as: Envarsus XR® (TAC XR)

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

1 site

Yale New Haven Transplantation Center
New Haven, Connecticut 06520, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03410654
Lead sponsor: Yale University
Collaborators: Veloxis Pharmaceuticals
Responsible party: Sponsor
First posted: Jan 25, 2018
Start date: Oct 24, 2018
Primary completion: Jan 1, 2024
Completion: Jul 1, 2024
Last update: Aug 21, 2024

Study contacts

Elizabeth Cohen, PharmD

principal investigator · Yale New Haven Hospital

Richard Formica, MD

principal investigator · Yale Univeristy

Oversight

FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Tacrolimus

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