Status:
COMPLETED
Envarsus XL Immunosuppression Following Liver Transplantation
Lead Sponsor:
Methodist Healthcare
Conditions:
Recipients of Liver Transplant
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The standard immunosuppressive regimen for liver transplantation includes twice daily tacrolimus (Prograf). In other transplantation models, there are potential benefits to extended release formulatio...
Eligibility Criteria
Inclusion
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18 years or older
- Recipients of a first-time liver transplant
- Serum Creatinine level less than 2.0 on Post-Operative Day 3-7
- Ability to take oral medication and be willing to adhere to the assigned immunosuppression regimen
- Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration
Exclusion
- Any prior use of tacrolimus or cyclosporine
- Recipients of prior organ transplant
- Need for hemodialysis in the week preceding or following liver transplantation
- Recipients of living donor liver or split deceased donor liver allografts
- Recipients of combined liver/kidney transplants
- Pregnancy or lactation
- Recipients of ABO incompatible liver allografts
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT03828058
Start Date
April 1 2019
End Date
December 31 2020
Last Update
January 12 2021
Active Locations (1)
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1
Methodist Healthcare, University Hospital
Memphis, Tennessee, United States, 38104