Conversion of Maintenance Prograf to Envarsus in Liver Transplant Recipients

• Status: Not yet recruiting
• Trial end date: 2024-10-31
• Target enrollment: 0
• Participant gender: All

Summary

Prograf and Envarsus are two different formulations of Tacrolimus which is used as an immunosuppressant in liver transplant (LT) patients. Prograf is currently used as part of the standard immunosuppression regimen for LT recipients at UHN. This study will compare the use of Prograf and Envarsus and their effects on liver and renal function, trough tacrolimus levels, drug-related adverse effects, and patient adherence. 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Collaborator: Paladin Labs Inc.
• Treatments: Tacrolimus

Criteria

Inclusion Criteria:

• Adult (>18 years) prevalent liver transplant recipient

• >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:

• Multiorgan transplant;

• severe intercurrent illness;

• severe cognitive impairment (all as determined by clinical team);

• unwilling to consent.