Envarsus Neurotoxicity Burden in Liver Transplant Patients

Medical University of South Carolina (MUSC)

Status and phase

Completed

Phase 4

Conditions

Liver Transplant; Complications

Neurotoxicity

Treatments

Drug: Envarsus

Drug: Tacrolimus Immediate release

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03823768

00083855

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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