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Envarsus XL Immunosuppression Following Liver Transplantation

Sponsor
Methodist Healthcare (Other)
Overall Status
Completed
CT.gov ID
NCT03828058
Collaborator
(none)
110
Enrollment
1
Location
2
Arms
21
Actual Duration (Months)
5.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
110 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
The study will be a prospective, randomized, open label study comparing Envarsus XR with twice daily prograf.The study will be a prospective, randomized, open label study comparing Envarsus XR with twice daily prograf.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Apr 1, 2019
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Dec 31, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Methodist Healthcare, University Hospital Memphis Tennessee United States 38104

    Sponsors and Collaborators

    • Methodist Healthcare

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Methodist Healthcare
    ClinicalTrials.gov Identifier:
    NCT03828058
    Other Study ID Numbers:
    • 18-05876-FB
    First Posted:
    Feb 4, 2019
    Last Update Posted:
    Jan 12, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Tacrolimus

    Study Results

    No Results Posted as of Jan 12, 2021