Envarsus XL Immunosuppression Following Liver Transplantation
| Status: | Not yet recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/6/2019 |
| Start Date: | February 1, 2019 |
| End Date: | December 31, 2022 |
| Contact: | Ryan Helmick, MD |
| Email: | rhelmick@uthsc.edu |
| Phone: | 9015168954 |
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
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.
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.
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
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