Prograf vs Envarsus for Liver Transplant Patients

Overseen By Erin Winter, BSC

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University Health Network, Toronto

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Nazia Selzner, MD

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

This trial is for adults over 18 who had a liver transplant more than a year ago, are on Prograf immunosuppression with specific blood test levels, stable liver and kidney function, no recent rejection episodes, and issues like tremors or sleep problems possibly due to their current medication.

Inclusion Criteria

I am on Prograf medication with specific blood level targets.

I am over 18 and have received a liver transplant.

It has been over a year since my liver transplant.

Exclusion Criteria

Severe cognitive impairment (as determined by clinical team)

Unwilling to consent

Multiorgan transplant

Treatment Details

Interventions

• Envarsus (Immunosuppressant)
• Prograf (Immunosuppressant)

Trial Overview The study compares two drugs used to prevent organ rejection after liver transplants: Prograf and Envarsus. Participants will either continue taking Prograf or switch to an equivalent dose of Envarsus once daily. They'll be monitored for 48 weeks to see effects on liver/renal function and drug side effects.

Participant Groups

Group I: Post-liver transplant patients receiving Prograf Active Control 1 Intervention

Group II: Post-liver transplant patients receiving Envarsus Active Control 1 Intervention

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Paladin Labs Inc.

Collaborator

Trials

4

Recruited

360+