Envarsus XL Immunosuppression Following Liver Transplantation

Methodist Healthcare110 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

110

Conditions

Recipients of Liver Transplant

Interventions

Envarsus XRDRUG

Envarsus XR to be administered orally, once a day. Dosage will be adjusted as determined by trough blood levels.

PrografDRUG

Prograf 2 mg BID to be administered orally, twice a day. Dosage will be adjusted as determined by trough blood levels.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Methodist Healthcare, University Hospital

Memphis, Tennessee, United States

Outcomes

Primary Outcomes

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.

Time frame: 3, 6, and 12 months post-transplant

Secondary Outcomes

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).

Time frame: 3, 6, and 12 months post-transplant

Data from ClinicalTrials.gov

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