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Envarsus XL Immunosuppression Following Liver Transplantation

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ClinicalTrials.gov Identifier: NCT03828058
Recruitment Status : Not yet recruiting
First Posted : February 4, 2019
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Recipients of Liver Transplant Drug: Envarsus XR Drug: Prograf Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 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.
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
Estimated Study Start Date : February 1, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

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 Name: Tacrolimus




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03828058


Contacts
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Contact: Ryan Helmick, MD 9015168954 rhelmick@uthsc.edu
Contact: Talana Vogel, EdD tvogel@uthsc.edu

Locations
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United States, Tennessee
Methodist Healthcare, University Hospital Not yet recruiting
Memphis, Tennessee, United States, 38104
Contact: Lori Kessler, PharmD    901-516-8633    lori.kessler@mlh.org   
Sub-Investigator: Luis Campos De La Borbolla, MD         
Principal Investigator: Uchenna Agbim, MD         
Sub-Investigator: James Eason, MD         
Sub-Investigator: Corey Eymard, MD         
Sub-Investigator: Peter Horton, MD         
Sub-Investigator: Daniel Maluf, MD         
Sub-Investigator: Valerie Mas, PhD         
Sub-Investigator: Nosratollah Nezakatgoo, MD         
Sponsors and Collaborators
Methodist Healthcare
Investigators
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Study Director: James Eason, MD The University of Tennessee Health Science Center, Department of Transplant

Publications of Results:

Other Publications:
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Responsible Party: Methodist Healthcare
ClinicalTrials.gov Identifier: NCT03828058     History of Changes
Other Study ID Numbers: 18-05876-FB
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Tacrolimus
Thymoglobulin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action