Status:
ACTIVE_NOT_RECRUITING
Evaluate the Clinical Benefits of EnvarsusXR in Post Liver Transplant
Lead Sponsor:
Albert Einstein Healthcare Network
Collaborating Sponsors:
Veloxis Pharmaceuticals
Conditions:
Post Liver Transplant
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
PHASE3
Brief 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 outcom...
Detailed Description
The main aim of this study is to assess the immunosuppressant adherence, efficacy, and safety in post liver transplant patients converted from twice daily tacro to once daily EnvarsusXR. Tacrolimus tr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT03386305
Start Date
December 13 2017
End Date
December 31 2021
Last Update
January 8 2021
Active Locations (1)
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1
Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141