Envarsus XL Immunosuppression Following Liver Transplantation

Methodist Healthcare

Status and phase: Completed; Phase 2

Conditions: Recipients of Liver Transplant

Treatments: Drug: Prograf; Drug: Envarsus XR

Study type: Interventional

Funder types: Other

Identifiers

NCT03828058

18-05876-FB

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Envarsus XR

Experimental group

Description:

Envarsus XR orally administered Daily

Treatment:

Drug: Envarsus XR

Prograf

Active Comparator group

Description:

Prograf PO administered twice daily Generic Name: tacrolimus Dosage of prograf will be determined by trough levels and adjusted accordingly

Treatment:

Drug: Prograf