Phase 4
N=30
Envarsus Neurotoxicity Burden in Liver Transplant Patients
Neurotoxicity · Liver Transplant; Complications
Bottom Line
View on ClinicalTrials.gov: NCT03823768 ↗Enrolled (actual)
30
Serious AEs
3.3%
Results posted
Jun 2024
Primary outcome: Primary: Change in Neurotoxicity Burden — -5; -4 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Envarsus (Drug); Tacrolimus Immediate release (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Neurotoxicity Burden |
-5; -4 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03823768). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.