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Recipients of Liver TransplantPhase 2NCT03828058

Envarsus XL Immunosuppression Following Liver Transplantation

A Phase 2 study testing Envarsus XR and Prograf in people with Recipients of Liver Transplant, run by Methodist Healthcare - Memphis at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recipients of Liver Transplant
What is being tested?
Envarsus XR and Prograf
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteUnited States
Study dates
1 Apr 2019to 31 Dec 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Methodist Healthcare, University Hospital

    Memphis, Tennessee, 38104

Other trials in United States

About this study

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

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.

Being tested
Envarsus XR, Prograf

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Envarsus XRDrug

    Also called ENVARSUS XR 0.75Mg Extended-Release Tablet, ENVARSUS XR 1Mg Extended-Release Tablet, ENVARSUS XR 4Mg Extended-Release Tablet

    Envarsus XR to be administered orally, once a day. Dosage will be adjusted as determined by trough blood levels.

  • PrografDrug

    Also called Tacrolimus

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

Study groups in NCT03828058
Study groupRoleWhat they receive
Envarsus XRExperimentalEnvarsus XR orally administered Daily
Receives: Drug: Envarsus XR
PrografActive comparatorPrograf PO administered twice daily Generic Name: tacrolimus Dosage of prograf will be determined by trough levels and adjusted accordingly
Receives: Drug: Prograf

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in estimated glomerular filtration rate (eGFR) over the first year after liver transplant

    We will be assessing differences in renal function based on calculated eGFR by MDRD6 equation.

    Measured: 3, 6, and 12 months post-transplant

Secondary outcomes (1)

  1. Quality of Life Assessment

    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).

    Measured: 3, 6, and 12 months post-transplant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2019
  2. Study start1 Apr 2019
  3. Primary completion31 Dec 2020
  4. Study completion31 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Model description
The study will be a prospective, randomized, open label study comparing Envarsus XR with twice daily prograf.
Masking
None (open label)
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03828058
Sponsor's protocol ID
18-05876-FB
Status last verified
Jan 2021
First submitted
11 Dec 2018
Last updated
12 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kadam P, Bhalerao S. Sample size calculation. Int J Ayurveda Res. 2010 Jan;1(1):55-7. doi: 10.4103/0974-7788.59946. No abstract available.

    PubMed 20532100

  • Abdelmalek MF, Humar A, Stickel F, Andreone P, Pascher A, Barroso E, Neff GW, Ranjan D, Toselli LT, Gane EJ, Scarola J, Alberts RG, Maller ES, Lo CM; Sirolimus Liver Conversion Trial Study Group. Sirolimus conversion regimen versus continued calcineurin inhibitors in liver allograft recipients: a randomized trial. Am J Transplant. 2012 Mar;12(3):694-705. doi: 10.1111/j.1600-6143.2011.03919.x. Epub 2012 Jan 10.

    PubMed 22233522

  • Backman L, Nicar M, Levy M, Distant D, Eisenstein C, Renard T, Goldstein R, Husberg B, Gonwa TA, Klintmalm G. FK506 trough levels in whole blood and plasma in liver transplant recipients. Correlation with clinical events and side effects. Transplantation. 1994 Feb 27;57(4):519-25.

    PubMed 7509516

  • Kong Y, Wang D, Shang Y, Liang W, Ling X, Guo Z, He X. Calcineurin-inhibitor minimization in liver transplant patients with calcineurin-inhibitor-related renal dysfunction: a meta-analysis. PLoS One. 2011;6(9):e24387. doi: 10.1371/journal.pone.0024387. Epub 2011 Sep 9.

    PubMed 21931704

  • Langone A, Steinberg SM, Gedaly R, Chan LK, Shah T, Sethi KD, Nigro V, Morgan JC; STRATO Investigators. Switching STudy of Kidney TRansplant PAtients with Tremor to LCP-TacrO (STRATO): an open-label, multicenter, prospective phase 3b study. Clin Transplant. 2015 Sep;29(9):796-805. doi: 10.1111/ctr.12581. Epub 2015 Aug 6.

    PubMed 26113208

  • Yoo MC, Vanatta JM, Modanlou KA, Campos L, Nezakatgoo N, Nair S, Eason JD. Steroid-free Liver Transplantation Using Rabbit Antithymocyte Globulin Induction in 500 Consecutive Patients. Transplantation. 2015 Jun;99(6):1231-5. doi: 10.1097/TP.0000000000000477.

    PubMed 25539464

  • Garnock-Jones KP. Tacrolimus prolonged release (Envarsus(R)): a review of its use in kidney and liver transplant recipients. Drugs. 2015 Feb;75(3):309-20. doi: 10.1007/s40265-015-0349-2.

    PubMed 25613762

  • Niel OR, Berthoux F, Albano L, Dahan P, Aoudia R, Gugenheim J, Cassuto E. Long-term glomerular filtration rate in liver allograft recipients according to the type of calcineurin inhibitors. Transplant Proc. 2009 Oct;41(8):3329-32. doi: 10.1016/j.transproceed.2009.09.034.

    PubMed 19857743

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Envarsus XR and Prograf in people with Recipients of Liver Transplant, run by Methodist Healthcare - Memphis at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in estimated glomerular filtration rate (eGFR) over the first year after liver transplant (time frame: 3, 6, and 12 months post-transplant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03828058, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2021.

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