Back to resultsEnvarsus Neurotoxicity Burden in Liver Transplant Patients
Primary Purpose
Neurotoxicity, Liver Transplant; Complications
Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Envarsus
Tacrolimus Immediate release
Sponsored by
About this trial
This is an interventional treatment trial for Neurotoxicity
Eligibility Criteria
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
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Arm 1: Control
Arm 2: Intervention
Arm Description
Tacrolimus immediate release twice daily for 6 months
Envarsus daily for 6 months.
Outcomes
Primary Outcome Measures
Change in neurotoxicity burden
Estimate the change from baseline to six months in neurotoxicity burden measured by a composite Patient Global Impression of Improvement score
Secondary Outcome Measures
Change in mean Fahn-Tolosa-Marin (FTM) score
Estimate the change in the mean FTM score among patients with self-reported tremors from baseline to six months.
Full Information
NCT ID
NCT03823768
First Posted
January 29, 2019
Last Updated
May 22, 2023
Sponsor
Medical University of South Carolina
Collaborators
Veloxis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT03823768
Brief Title
Envarsus Neurotoxicity Burden in Liver Transplant Patients
Official Title
The Effect of Conversion to Once-Daily Envarsus® on the Neurologic Toxicity Burden in Liver Transplant Recipients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 31, 2020 (Actual)
Primary Completion Date
April 30, 2023 (Actual)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
Collaborators
Veloxis Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurotoxicity, Liver Transplant; Complications
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: Control
Arm Type
Active Comparator
Arm Description
Tacrolimus immediate release twice daily for 6 months
Arm Title
Arm 2: Intervention
Arm Type
Experimental
Arm Description
Envarsus daily for 6 months.
Intervention Type
Drug
Intervention Name(s)
Envarsus
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Tacrolimus Immediate release
Intervention Description
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 Outcome Measure Information:
Title
Change in neurotoxicity burden
Description
Estimate the change from baseline to six months in neurotoxicity burden measured by a composite Patient Global Impression of Improvement score
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in mean Fahn-Tolosa-Marin (FTM) score
Description
Estimate the change in the mean FTM score among patients with self-reported tremors from baseline to six months.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Derek Dubay, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Envarsus Neurotoxicity Burden in Liver Transplant Patients
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