Evaluate the Clinical Benefits of EnvarsusXR in Post Liver Transplant

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Albert Einstein Healthcare Network

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This study will evaluate the medication adherence, clinical efficacy, and safety of EnvarsusXR in stable post liver transplant patient using a Phase III randomized controlled study. The primary outcome is change in medication adherence from baseline to the end of the study, assessed using a validated instrument (BAASIS- Basel Assessment of Adherence with Immunosuppressive medication Scales) and standard deviation of Tacrolimus levels.

Eligibility Criteria

Inclusion Criteria

Patients who are 1 year post liver transplant, but within 5 years of transplant

Serum Creatinine<= 2.5 mg/dl; AST,ALT, AP and GGT<=2 times ULN

Patient must be on a stable tacrolimus dose, with tacrolimus trough levels between 5-12 ng/ml for 4 or more weeks before enrolment

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: EnvarsusXR armExperimental Treatment1 Intervention

Patients are converted to once daily EnvarsusXR (study drug). The patients continue taking this medication for 9 months of the study. Initial dosage will be 0.8 times the total daily dose of tacro bid, due to higher bioavailability. All subsequent dose adjustments will be based on maintenance of target tacro trough levels within range of 5-12 ng/ml.

Group II: Standard of care armActive Control1 Intervention

Post Liver Transplant patients take Tacrolimus twice daily as a part of standard of care. Those participating in the study will continue to take tacrolimus twice daily, as apart of their regular care. As a part of the study, they will complete the medication adherence and quality of life instruments.