Conversion of Maintenance Prograf to Envarsus in Liver Transplant Recipients
NCT ID: NCT05655273
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
PHASE4
40 participants
INTERVENTIONAL
2024-01-01
2026-02-28
Brief Summary
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Detailed Description
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Envarsus is an extended-release formulation of tacrolimus that provides similar drug exposure to tacrolimus at a 30% lower dose but with a once daily dosing regimen. Envarsus dosing also results in a lower peak tacrolimus level compared to Prograf. In this way, it is hoped that Envarsus may provide similar therapeutic efficacy as Prograf but with fewer adverse effects. In addition, the simpler dosing regimen is expected to enhance patient adherence and quality of life.
The present study is aimed at evaluating the impact of a switch from Prograf to Envarsus on liver and renal function, trough tacrolimus levels, drug-related adverse effects and adherence. It hypothesizes that once daily Envarsus can be substituted at reduced daily dose for twice daily Prograf in stable liver transplant recipients without clinically meaningful changes in liver allograft function while reducing tacrolimus side effects, reducing cumulative daily dose of the drug and increasing adherence to treatment and quality of life.The results of this study have the potential to change current practice. Trial design is a pilot randomized trial. The study aims to recruit 40 patients from UHN's LT program and they will be randomized 1:1 to either stay on their current dose of Prograf or be converted to a once-daily equivalent dose of Envarsus. Both groups of patients will be followed for 48 weeks. This study will compare the change from baseline to week 48 in liver and renal function, tacrolimus-related side effects and patient reported outcomes between the two study groups.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Post-liver transplant patients receiving Prograf
Prograf
Participants randomized to the Prograf (control) arm will continue with their current twice daily dosing of Prograf.
Post-liver transplant patients receiving Envarsus
Envarsus
Participants randomized to Envarsus arm will have their current daily dose of Prograf converted to once-daily Envarsus dose according to the following ratio: 0.7 x the current daily Prograf dose. Envarsus is available in 3 dose strengths- 0.75mg, 1.0mg, and 4.0mg. The actual dose of Envarsus will be rounded to an amount that can be administered using the above tablet strengths.
Interventions
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Prograf
Participants randomized to the Prograf (control) arm will continue with their current twice daily dosing of Prograf.
Envarsus
Participants randomized to Envarsus arm will have their current daily dose of Prograf converted to once-daily Envarsus dose according to the following ratio: 0.7 x the current daily Prograf dose. Envarsus is available in 3 dose strengths- 0.75mg, 1.0mg, and 4.0mg. The actual dose of Envarsus will be rounded to an amount that can be administered using the above tablet strengths.
Eligibility Criteria
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Inclusion Criteria
* \>12 months after liver transplant
* Prograf-based maintenance immunosuppression with targeted tacrolimus trough level of 5-10 ug/L
* Stable liver allograft function (defined as ASL \& ALT \<30, Bilirubin \<20 \& ALP\<150 at baseline visit or within 4 weeks of baseline visit)
* Stable renal function (creatinine \< 180 µmol/l and eGFR \> 40 ml/min) at baseline visit (or within 4 weeks of baseline visit)
* No episode of acute rejection within 6 months of baseline visit
* Elevated creatinine (defined as \>ULN) OR Significant symptoms (by patient self-report) potentially associated with tacrolimus (eg. tremor, difficulty to concentrate, insomnia) OR difficulty to adhere to a twice daily regimen
Exclusion Criteria
* severe intercurrent illness;
* severe cognitive impairment (all as determined by clinical team);
* unwilling to consent.
18 Years
99 Years
ALL
No
Sponsors
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Paladin Labs Inc.
OTHER
University Health Network, Toronto
OTHER
Responsible Party
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Principal Investigators
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Nazia Selzner, MD
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto
Locations
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Toronto General Hospital
Toronto, Ontario, Canada
Countries
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Other Identifiers
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22-5210
Identifier Type: -
Identifier Source: org_study_id