Evaluate the Clinical Benefits of EnvarsusXR in Post Liver Transplant


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.

Study Start Date

December, 13 2017

Estimated Completion Date

December 2019


  • Drug: Tacrolimus
  • Drug: EnvarsusXR

Study ID

Albert Einstein Healthcare Network -- 5024



Trial ID


Study Type


Trial Phase

Phase 2/Phase 3

Enrollment Quota



Albert Einstein Healthcare Network

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




18 Years to 100 Years

Accepts Healthy Volunteers


Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Einstein Medical Center - Philadelphia, Pennsylvania 128.9 miles Manisha Verma 215-456-1026 vermam@einstein.edu

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