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OpenTrials
Completed

NCT Number: NCT03823768

Envarsus Neurotoxicity Burden in Liver Transplant Patients

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.

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Key information

Conditions

Neurotoxicity Chemically-Induced Disorders Liver Transplant; Complications Nervous System Diseases Neurotoxicity Syndromes Poisoning

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female adult (≥18 years old) with a history of liver or liver/kidney transplant within the first 6 months of transplant.
  • Patients must be capable of understanding the purposes and risks of the study and have the ability to give written informed consent and be willing to participate and comply with the study.

Exclusion criteria

  • Patients will be excluded if they are pregnant or nursing females or males with a pregnant female partner
  • HIV positive (HIV ab +)
  • Unable to tolerate oral medications
  • Use of another investigational product within thirty days prior to receiving study medication
  • Moderate acute cellular rejection (RAI ≥ 5) within the past month
  • A condition that is known to cause tremor such as essential tremor, Parkinson disease, or enhanced physiologic tremor.
  • Patients taking medications known to induce tremors or dopamine blocking agents
  • A condition or disorder that, in the opinion of the investigator, may adversely affect the outcome of the study or the safety of the subject

Treatment and study plan

Envarsus

Drug

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 release

Drug

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.

Primary outcomes

  1. Change in Neurotoxicity Burden

    Time frame: 6 months

    Estimate the change from baseline to six months in neurotoxicity burden measured by a composite Patient Global Impression of Improvement score (PGI-I, with a range of 4-28) The PGI-I is a global index that may be used to rate the response of a condition to a therapy (transition scale). Scale min=4, scale max=28. The scale is made up of four questions, each question has a total of 7 responses, the total score is the sum of each questions choice (1-7). Higher values represent a worsening condition. A score of 16 would indicate no overall change. A score of 15 or lower indicates improvement in the condition and a score of 17 or higher indicates a worsening of the condition. A score of 28 would indicate "very much worse," while a score of 4 would indicate "very much better." A relative change of 2 points would be considered a significant change from baseline.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • Veloxis Pharmaceuticals

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Jan 30, 2019
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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