Clinical trial NCT03828058: Envarsus XL Immunosuppression Following Liver Transplantation
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Recipients of Liver Transplant
Lead sponsor: Methodist Healthcare
Sponsor class: OTHER
First posted: 2019-02-04
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: The study will be a prospective, randomized, open label study comparing Envarsus XR with twice daily prograf.
Primary purpose: TREATMENT

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 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.


Eligibility 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

Primary outcomes:
measure: Change in estimated glomerular filtration rate (eGFR) over the first year after liver transplant
timeFrame: 3, 6, and 12 months post-transplant
Secondary outcomes:
measure: Quality of Life Assessment
timeFrame: 3, 6, and 12 months post-transplant
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Methodist Healthcare, University Hospital
state: Tennessee
Study officials:
affiliation: The University of Tennessee Health Science Center, Department of Transplant
name: James Eason, MD
role: STUDY_DIRECTOR
References:
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citation: Yoo MC, Vanatta JM, Modanlou KA, Campos L, Nezakatgoo N, Nair S, Eason JD. Steroid-free Liver Transplantation Using Rabbit Antithymocyte Globulin Induction in 500 Consecutive Patients. Transplantation. 2015 Jun;99(6):1231-5. doi: 10.1097/TP.0000000000000477.
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