Evaluate the Clinical Benefits of EnvarsusXR in Post Liver Transplant

Running, not enrolling · Phase 2/Phase 3

Conditions studied: Post Liver Transplant

In brief

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.

Key facts

Study ID

NCT03386305

Run by

Albert Einstein Healthcare Network

People needed

35

Starts

2017-12-13

Expected to finish

2021-12-31

Last updated by the study team

2021-01-08

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Einstein Medical Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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