Envarsus XL Immunosuppression Following Liver Transplantation

Phase 2

Completed

• Conditions: Recipients of Liver Transplant
• Interventions: Drug: Envarsus XR; Drug: Prograf

• Registration Number: NCT03828058
• Lead Sponsor: Methodist Healthcare

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-11
• Study First Submitted QC: 2019-01-31
• Study First Posted: 2019-02-04
• Study Start: 2019-04-01
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-11
• Last Update Posted: 2021-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Envarsus XR	Envarsus XR	Envarsus XR orally administered Daily
Prograf	Prograf	Prograf PO administered twice daily Generic Name: tacrolimus Dosage of prograf will be determined by trough levels and adjusted accordingly

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Methodist Healthcare, University Hospital; 🇺🇸 Memphis, Tennessee, United States