Envarsus XL Immunosuppression Following Liver Transplantation

January 11, 2021 updated by: Methodist Healthcare

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • Methodist Healthcare, University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Envarsus XR
Envarsus XR orally administered Daily
Drug: Envarsus XR
Envarsus XR to be administered orally, once a day. Dosage will be adjusted as determined by trough blood levels.
Other Names:
  • ENVARSUS XR 0.75Mg Extended-Release Tablet
  • ENVARSUS XR 1Mg Extended-Release Tablet
  • ENVARSUS XR 4Mg Extended-Release Tablet
ACTIVE_COMPARATOR: Prograf

Prograf PO administered twice daily Generic Name: tacrolimus

Dosage of prograf will be determined by trough levels and adjusted accordingly
Drug: Prograf
Prograf 2 mg BID to be administered orally, twice a day. Dosage will be adjusted as determined by trough blood levels.
Other Names:
  • Tacrolimus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in estimated glomerular filtration rate (eGFR) over the first year after liver transplant
Time Frame: 3, 6, and 12 months post-transplant
We will be assessing differences in renal function based on calculated eGFR by MDRD6 equation.
3, 6, and 12 months post-transplant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life Assessment
Time Frame: 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).
3, 6, and 12 months post-transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Methodist Healthcare

Investigators

  • Study Director: James Eason, MD, The University of Tennessee Health Science Center, Department of Transplant

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2019

Primary Completion (ACTUAL)

December 31, 2020

Study Completion (ACTUAL)

December 31, 2020

Study Registration Dates

First Submitted

December 11, 2018

First Submitted That Met QC Criteria

January 31, 2019

First Posted (ACTUAL)

February 4, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 12, 2021

Last Update Submitted That Met QC Criteria

January 11, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-05876-FB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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