NCT03823768

Envarsus Neurotoxicity Burden in Liver Transplant Patients

The Effect of Conversion to Once-Daily Envarsus® on the Neurologic Toxicity Burden in Liver Transplant Recipients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Neurotoxicity
• Liver Transplant; Complications

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-01-31
• Primary completion: 2023-04-30
• Completion: 2024-01-30
• First posted: 2019-01-30
• Last updated: 2025-03-30
• Results posted: 2024-06-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study