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Envarsus Neurotoxicity Burden in Liver Transplant Patients

NCT03823768 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-03-30

Study results available
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Summary

This study will compare neurologic side effects associated with two immunosuppressant medications used in liver transplant patients. The standard therapy of twice daily immediate release Tacrolimus will be compared to Envarsus once daily. We hypothesize that Envarsus will show a lower rate of neurologic side effects than immediate release tacrolimus.

Conditions

Interventions

DRUG

Envarsus

Subjects in this group will take Envarsus daily for 6 months of treatment (goal 24 hour trough: 3-10 ng/mL) +/- adjunctive agent and prednisone.

DRUG

Tacrolimus Immediate release

Subjects in this group will take Tacrolimus immediate release for 6 months of treatment (goal 12 hour trough: 3-10 ng/mL) +/- adjunctive agent and prednisone.

Sponsors & Collaborators

  • Veloxis Pharmaceuticals

    collaborator INDUSTRY

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Derek Dubay, MD · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-31
Primary Completion
2023-04-30
Completion
2024-01-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03823768 on ClinicalTrials.gov