Conversion of Maintenance Prograf to Envarsus in Liver Transplant Recipients

Launched by UNIVERSITY HEALTH NETWORK, TORONTO · Dec 8, 2022

Keywords

ClinConnect Summary

Tacrolimus (Prograf ©) has become part of the standard of care for patients receiving solid organ transplants and is part of the immunosuppressive protocol (along with prednisone and mycophenolate mofetil \[CellCept ©\]) used by liver transplant recipients at University Health Network (UHN). Tacrolimus is associated with several toxicities including renal injury, tremor, pancreatic islet β-cell injury (leading to diabetes) and hyperlipidemia. As a result of these potential toxicities, careful therapeutic drug monitoring of tacrolimus is a key component of post-transplant management. Tacroli...

Gender

ALL

Eligibility 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.

Trial Officials