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OpenTrials
Completed

NCT Number: NCT03828058

Envarsus XL Immunosuppression 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.

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Key information

Conditions

Recipients of Liver Transplant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Methodist Healthcare, University Hospital

Memphis, Tennessee, 38104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Male or female, aged 18 years or older
  • Recipients of a first-time liver transplant
  • Serum Creatinine level less than 2.0 on Post-Operative Day 3-7
  • Ability to take oral medication and be willing to adhere to the assigned immunosuppression regimen
  • Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration

Exclusion criteria

  • Any prior use of tacrolimus or cyclosporine
  • Recipients of prior organ transplant
  • Need for hemodialysis in the week preceding or following liver transplantation
  • Recipients of living donor liver or split deceased donor liver allografts
  • Recipients of combined liver/kidney transplants
  • Pregnancy or lactation
  • Recipients of ABO incompatible liver allografts

Treatment and study plan

Envarsus XR

Drug

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

Prograf

Drug

Prograf 2 mg BID to be administered orally, twice a day. Dosage will be adjusted as determined by trough blood levels.

Other names: Tacrolimus

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Methodist Healthcare - Memphis

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 4, 2019
Registry last updated
Jan 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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