Envarsus XL Immunosuppression Following Liver Transplantation

Study Overview
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Brief Summary
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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.

Official Title
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A 12 Month Single-center, Open Label, Randomized, Comparative Study to Evaluate Envarsus XL Steroid-free Rabbit Anti-thymocyte Globulin Induction on Renal Function and Health-related Quality of Life Following Liver Transplantation

Conditions
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Recipients of Liver Transplant

Intervention / Treatment
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* Drug: Envarsus XR
* Drug: Prograf


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: The study will be a prospective, randomized, open label study comparing Envarsus XR with twice daily prograf.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Envarsus XR<br>Envarsus XR orally administered Daily | Drug: Envarsus XR<br>* Envarsus XR to be administered orally, once a day. Dosage will be adjusted as determined by trough blood levels.<br>* Other names: ENVARSUS XR 4Mg Extended-Release Tablet;|
| Active Comparator: Prograf<br>Prograf PO administered twice daily Generic Name: tacrolimus Dosage of prograf will be determined by trough levels and adjusted accordingly | Drug: Prograf<br>* Prograf 2 mg BID to be administered orally, twice a day. Dosage will be adjusted as determined by trough blood levels.<br>* Other names: Tacrolimus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in estimated glomerular filtration rate (eGFR) over the first year after liver transplant | We will be assessing differences in renal function based on calculated eGFR by MDRD6 equation. | 3, 6, and 12 months post-transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Assessment | We will be using the RAND Short Form 36 (SF36) healthcare survey to assess patient reported quality of life across a broad spectrum ranging from physical health and function to emotional well being. Each sub scale score ranges from 0 (worse) to 100 (best). | 3, 6, and 12 months post-transplant |