Envarsus Neurotoxicity Burden in Liver Transplant Patients

Liver Transplant; Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03823768
• Other study ID #: 00083855
• Status: Completed
• Phase: Phase 4
• Start date: January 31, 2020
• Est. completion date: January 30, 2024

Study information

• Verified date: March 2024
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 30, 2024
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female adult (=18 years old) with a history of liver or liver/kidney transplant within the first 6 months of transplant.

2. 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:

1. Patients will be excluded if they are pregnant or nursing females or males with a pregnant female partner

2. HIV positive (HIV ab +)

3. Unable to tolerate oral medications

4. Use of another investigational product within thirty days prior to receiving study medication

5. Moderate acute cellular rejection (RAI = 5) within the past month

6. A condition that is known to cause tremor such as essential tremor, Parkinson disease, or enhanced physiologic tremor.

7. Patients taking medications known to induce tremors or dopamine blocking agents

8. 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

Related Conditions & MeSH terms

• Liver Transplant; Complications
• Neurotoxicity
• Neurotoxicity Syndromes

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	Veloxis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months
Secondary	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.	6 months