Recipients of Liver Transplant
Conditions
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.
Interventions
DRUGEnvarsus XR
Envarsus XR to be administered orally, once a day. Dosage will be adjusted as determined by trough blood levels.
DRUGPrograf
Prograf 2 mg BID to be administered orally, twice a day. Dosage will be adjusted as determined by trough blood levels.
Sponsors
Methodist Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study will be a prospective, randomized, open label study comparing Envarsus XR with twice daily prograf.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in estimated glomerular filtration rate (eGFR) over the first year after liver transplant | 3, 6, and 12 months post-transplant | We will be assessing differences in renal function based on calculated eGFR by MDRD6 equation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Assessment | 3, 6, and 12 months post-transplant | 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). |
Countries
United States
Outcome results
None listed