Overview

Envarsus XL Immunosuppression Following Liver Transplantation

Status:
Completed

Trial end date:
2020-12-31

Target enrollment:
0

Participant gender:
All

Summary

The standard immunosuppressive regimen for liver transplantation includes twice daily tacrolimus (Prograf). In other transplantation models, there are potential benefits to extended release formulations as lower peak concentrations are thought to have lower rates of nephrotoxicity. Additionally, compliance with once daily medications is felt to be easier than twice daily medications. Our aim is to look at our prospective liver transplant group and see if once daily tacrolimus (Envarsus XR) results in improved renal function as well as improved health care quality of life.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Methodist Healthcare

Treatments:

Tacrolimus
Thymoglobulin

Criteria

Inclusion Criteria:

1. Provision of signed and dated informed consent form

2. Stated willingness to comply with all study procedures and availability for the
duration of the study

3. Male or female, aged 18 years or older

4. Recipients of a first-time liver transplant

5. Serum Creatinine level less than 2.0 on Post-Operative Day 3-7

6. Ability to take oral medication and be willing to adhere to the assigned
immunosuppression regimen

7. Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study
duration

Exclusion Criteria:

1. Any prior use of tacrolimus or cyclosporine

2. Recipients of prior organ transplant

3. Need for hemodialysis in the week preceding or following liver transplantation

4. Recipients of living donor liver or split deceased donor liver allografts

5. Recipients of combined liver/kidney transplants

6. Pregnancy or lactation

7. Recipients of ABO incompatible liver allografts