Envarsus Neurotoxicity Burden in Liver Transplant Patients

Phase 4

Completed

• Conditions: Liver Transplant; Complications; Neurotoxicity
• Interventions: Drug: Tacrolimus Immediate release; Drug: Envarsus

• Registration Number: NCT03823768
• Lead Sponsor: Medical University of South Carolina

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-01-29
• Study First Submitted QC: 2019-01-29
• Study First Posted: 2019-01-30
• Study Start: 2020-01-31
• Primary Completion: 2023-04-30
• Study Completion: 2024-01-30
• Results First Submitted: 2024-04-10
• Status Verified: 2024-06
• Results First Submitted QC: 2024-06-25
• Last Update Submitted: 2024-06-25
• Results First Posted: 2024-06-27
• Last Update Posted: 2024-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: Control	Tacrolimus Immediate release	Tacrolimus immediate release twice daily for 6 months
Arm 2: Intervention	Envarsus	Envarsus daily for 6 months.

Primary Outcome Measures

Name	Time	Method
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 (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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States