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

Kidney Transplant; Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03410654
• Other study ID #: 2000022307
• Secondary ID: 000
• Status: Recruiting
• Phase: Early Phase 1
• Start date: October 24, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Yale University
• Contact: Elizabeth Cohen, PharmD
• Phone: 203-688-1841
• Email: elizabeth.cohen[@]ynhh.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: December 31, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplant; Complications

Intervention

Drug:
• Tacrolimus, Extended Release, (Envarsus Xr)
After conversion of tacrolimus immediate release to tacrolimus extended release.

Locations

Country	Name	City	State
United States	Yale New Haven Transplantation Center	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Veloxis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cognitive assessment at baseline	cognitive assessment at baseline using MoCA test 7.1	baseline
Primary	cognitive improvement from baseline	cognitive evaluation from baseline average for adults using NIH Toolbox Cognitive Domain	3 months after enrollment
Secondary	MoCA cognitive assessment	cognitive assessment using MoCA 7.2	3 months after enrollment
Secondary	NIH Toolbox cognitive test	NIH Toolbox Flanker Inhibitory Control and Attention Test	baseline
Secondary	NIH Toolbox cognitive test	NIH Toolbox Flanker Inhibitory Control and Attention Test	3 months
Secondary	NIH Toolbox cognitive test	NIH Toolbox Dimensional Change Card Sort Test	baseline
Secondary	NIH Toolbox cognitive test	NIH Toolbox Dimensional Change Card Sort Test	3 months
Secondary	NIH Toolbox cognitive test	NIH Toolbox Picture Sequence Memory Test Version A	baseline
Secondary	NIH Toolbox cognitive test	NIH Toolbox Picture Sequence Memory Test Version B	3 months
Secondary	NIH Toolbox cognitive test	NIH Toolbox Pattern Comparison Processing Speed Test	baseline
Secondary	NIH Toolbox cognitive test	NIH Toolbox Pattern Comparison Processing Speed Test	3 months
Secondary	NIH Toolbox cognitive test	NIH Toolbox List Sorting Working Memory Test	baseline
Secondary	NIH Toolbox cognitive test	NIH Toolbox List Sorting Working Memory Test	3 months
Secondary	NIH Toolbox cognitive test	NIH Toolbox Reading Recognition Test	baseline
Secondary	NIH Toolbox cognitive test	NIH Toolbox Reading Recognition Test	3 months