Evaluate the Clinical Benefits of EnvarsusXR in Post Liver Transplant

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Albert Einstein Healthcare Network
• Collaborator: Veloxis Pharmaceuticals
• Treatments: Tacrolimus

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

Exclusion Criteria:

• Cognitive impairment which precludes participation

• Projected survival, in the opinion of the provider, of less than three months

• Any other solid organ transplant (kidney or pancreas)

• Use of any drug which is known to interfere with tacrolimus metabolism