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Immunosuppressant

Extended-Release Tacrolimus for Liver Transplant Complications

Phase 4
Recruiting
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Individuals with congenital long QT syndrome
Patients who require a re-transplant, or receive multi-visceral transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-10 years
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trialwill study if a new form of an approved medicine can reduce side effects and improve outcomes after liver transplant.

Who is the study for?
This trial is for adults who had a liver transplant at the University of Alberta. It's not for those needing another transplant, with severe kidney issues (eGFR < 45), acute kidney injury stopping current treatments, congenital long QT syndrome, or high bilirubin levels (>100 umol/L) after their transplant.
What is being tested?
The study compares two drugs to prevent organ rejection after liver transplantation: standard Prograf and a new formulation called Envarsus. The goal is to see if Envarsus has fewer side effects and better clinical outcomes than Prograf.
What are the potential side effects?
Tacrolimus can cause kidney problems, tremors, headaches, sleep difficulties, sensory changes in legs, seizures or confusion; high blood pressure; anemia; diabetes; abnormal cholesterol levels and weight gain.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have congenital long QT syndrome.
Select...
I need a new organ transplant or multiple organ transplants.
Select...
I stopped taking calcineurin inhibitors due to acute kidney injury.
Select...
My kidney function is low (eGFR < 45).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety of Envarsus as indicated by adverse events
Secondary study objectives
Graft Survival
Impact on quality of life (QOL) - Chronic Liver Disease Questionnaire
Impact on quality of life (QOL) - EuroQuol Visual Analogue Scale (VAS)
+10 more

Awards & Highlights

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.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Prograf (SOC)Experimental Treatment1 Intervention
Prograf tablet Dose 0.10 - 0.15mg/Kg daily Frequency: 2 doses per day (dose above split in half for each dose)
Group II: EnvarsusActive Control1 Intervention
Envarsus tablet Dose 0.11 - 0.13 mg/Kg/day Frequency: once per day

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor
942 Previous Clinical Trials
434,315 Total Patients Enrolled

Media Library

Envarsus Oral Product (Immunosuppressant) Clinical Trial Eligibility Overview. Trial Name: NCT05242315 — Phase 4
Cardiovascular Disease Research Study Groups: Envarsus, Prograf (SOC)
Cardiovascular Disease Clinical Trial 2023: Envarsus Oral Product Highlights & Side Effects. Trial Name: NCT05242315 — Phase 4
Envarsus Oral Product (Immunosuppressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05242315 — Phase 4
~15 spots leftby Jul 2025
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