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.
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
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.
- Conditions
- Recipients of Liver Transplant
- 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 group | Role | What they receive |
|---|---|---|
| Envarsus XR | Experimental | Envarsus XR orally administered Daily Receives: Drug: Envarsus XR |
| Prograf | Active comparator | Prograf 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.
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)
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.
- First posted4 Feb 2019
- Study start1 Apr 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Recipients of Liver TransplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Methodist Healthcare - Memphis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Eason, MD, Study director, The University of Tennessee Health Science Center, Department of Transplant
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 20532100Abdelmalek 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 22233522Backman 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 7509516Kong 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 21931704Langone 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 26113208Yoo 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 25539464Garnock-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 25613762Niel 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03828058
- Acronym / sponsor ID
- 18-05876-FB
- Conditions
- Recipients of Liver Transplant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Methodist Healthcare - MemphisUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 4 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will be a prospective, randomized, open label study comparing Envarsus XR with twice daily prograf.
| Arm | Type | Receives |
|---|---|---|
| Envarsus XR | Experimental | Drug: Envarsus XREnvarsus XR orally administered Daily |
| Prograf | Active comparator | Drug: PrografPrograf PO administered twice daily Generic Name: tacrolimus Dosage of prograf will be determined by trough levels and adjusted accordingly |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Envarsus XRAlso: ENVARSUS XR 0.75Mg Extended-Release Tablet, ENVARSUS XR 1Mg Extended-Release Tablet, ENVARSUS XR 4Mg Extended-Release TabletEnvarsus XR to be administered orally, once a day. Dosage will be adjusted as determined by trough blood levels. | Drug | Envarsus XR |
| PrografAlso: TacrolimusPrograf 2 mg BID to be administered orally, twice a day. Dosage will be adjusted as determined by trough blood levels. | Drug | Prograf |
Primary outcome
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.
1 secondary outcome
Quality of Life Assessment
Time frame: 3, 6, and 12 months post-transplant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- Background: PubMed 20532100Kadam 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.
- Results publication: PubMed 22233522Abdelmalek 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.
- Results publication: PubMed 7509516Backman 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.
- Results publication: PubMed 21931704Kong 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.
- Results publication: PubMed 26113208Langone 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.
- Results publication: PubMed 25539464Yoo 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.
- Results publication: PubMed 25613762Garnock-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.
- Results publication: PubMed 19857743Niel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Eason, MD study director
The University of Tennessee Health Science Center, Department of Transplant
1 site in 1 country: see every site and its status.
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.