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

00083855

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.

2020-01-31

2023-04-30

2024-01-30

Completed

Early phase I

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. 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ACTUAL'}}

2024-03-20