Envarsus Neurotoxicity Burden in Liver Transplant Patients

• Sponsor: Medical University of South Carolina (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03823768
• Collaborator: Veloxis Pharmaceuticals (Industry)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 36.9
• Patients Per Site Per Month: 0.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Neurotoxicity; Liver Transplant; Complications	Drug: Envarsus; Drug: Tacrolimus Immediate release	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effect of Conversion to Once-Daily Envarsus® on the Neurologic Toxicity Burden in Liver Transplant Recipients
• Actual Study Start Date: Jan 31, 2020
• Anticipated Primary Completion Date: Jan 31, 2023
• Anticipated Study Completion Date: Feb 28, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm 1: Control Tacrolimus immediate release twice daily for 6 months	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.
Experimental: Arm 2: Intervention Envarsus daily for 6 months.	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.

Outcome Measures

Primary Outcome Measures

1. Change in neurotoxicity burden [6 months]

   Estimate the change from baseline to six months in neurotoxicity burden measured by a composite Patient Global Impression of Improvement score

Secondary Outcome Measures

1. Change in mean Fahn-Tolosa-Marin (FTM) score [6 months]

   Estimate the change in the mean FTM score among patients with self-reported tremors from baseline to six months.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of South Carolina	Charleston	South Carolina	United States	29425

Sponsors and Collaborators

• Medical University of South Carolina
• Veloxis Pharmaceuticals

Investigators

• Principal Investigator: Derek Dubay, MD, Medical University of South Carolina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medical University of South Carolina
• ClinicalTrials.gov Identifier: NCT03823768
• Other Study ID Numbers: 00083855
• First Posted: Jan 30, 2019
• Last Update Posted: Apr 22, 2022
• Last Verified: Apr 1, 2022

• 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
• Additional relevant MeSH terms: Neurotoxicity Syndromes; Tacrolimus

Study Results

No Results Posted as of Apr 22, 2022