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Immunosuppressant

Prograf vs Envarsus for Liver Transplant Patients

Phase 4
Waitlist Available
Led By Nazia Selzner, MD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult (>18 years) prevalent liver transplant recipient
On Prograf-based maintenance immunosuppression with targeted tacrolimus trough level of 5-10 ug/L
Must not have
Multiorgan transplant
Severe intercurrent illness
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

"This trial compares two different forms of a medication called Tacrolimus used to prevent organ rejection in liver transplant patients. The study will look at how Prograf and Envarsus affect liver and kidney function

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects include those related to Tacrolimus such as kidney problems, high blood pressure, diabetes, nervous system symptoms like tremors or trouble sleeping, gastrointestinal issues, infections due to weakened immune response.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 18 and have received a liver transplant.
Select...
I am on Prograf medication with specific blood level targets.
Select...
My liver is functioning well, with normal enzyme levels.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have a severe illness besides my cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Post-liver transplant patients receiving PrografActive Control1 Intervention
Group II: Post-liver transplant patients receiving EnvarsusActive Control1 Intervention

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,523 Previous Clinical Trials
503,298 Total Patients Enrolled
Paladin Labs Inc.OTHER
3 Previous Clinical Trials
315 Total Patients Enrolled
Nazia Selzner, MDPrincipal InvestigatorUniversity Health Network, Toronto
~13 spots leftby Apr 2025
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