CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 30 enrolled
Drug / intervention
Envarsus +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03823768
NCT03823768Phase 4Completed
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The Effect of Conversion to Once-Daily Envarsus® on the Neurologic Toxicity Burden in Liver Transplant Recipients

Medical University of South Carolina·interventional·Posted Jan 30, 2019·Updated Mar 30, 2025

In Brief

A Phase 4 clinical trial evaluating Envarsus and Tacrolimus Immediate release for Neurotoxicity and Liver Transplant; Complications. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeurotoxicity, Liver Transplant; Complications
CountriesUnited States
CollaboratorsVeloxis Pharmaceuticals

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedJan 30, 2019
Enrollment StartJan 31, 2020
Primary CompletionApr 30, 2023
Study CompletionJan 30, 2024
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 7.4 years ago

Interventions

Envarsusdrug

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.

Tacrolimus Immediate releasedrug

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.