Evaluate the Clinical Benefits of EnvarsusXR in Post Liver Transplant

Description

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

Interventions

  • Drug: Tacrolimus
  • Drug: EnvarsusXR

Study ID

Albert Einstein Healthcare Network -- 5024

Status

Unknown

Trial ID

NCT03386305

Study Type

Interventional

Trial Phase

Phase 2/Phase 3

Enrollment Quota

120

Sponsor

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

Gender

All

Ages

18 Years to 100 Years

Accepts Healthy Volunteers

No

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

ClinicalTrialsLocator.com provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from ClinicalTrials.gov. This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.