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

NCT03410654 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-08-21

No results posted yet for this 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.

Conditions

  • Kidney Transplant; Complications

Interventions

DRUG

Tacrolimus, Extended Release, (Envarsus Xr)

After conversion of tacrolimus immediate release to tacrolimus extended release.

Sponsors & Collaborators

  • Veloxis Pharmaceuticals

    collaborator INDUSTRY

  • Yale University

    lead OTHER

Principal Investigators

  • Elizabeth Cohen, PharmD · Yale New Haven Hospital

  • Richard Formica, MD · Yale Univeristy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-24
Primary Completion
2024-01-01
Completion
2024-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03410654 on ClinicalTrials.gov