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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

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

Side effects data

From 2022 Phase 4 trial • 97 Patients • NCT03020589
98%
Anemia
83%
Hypomagnesemia
75%
Leukopenia
70%
Hyperkalemia
57%
Abnormal renal function
50%
Hypophosphatemia
50%
Increase creatinine
45%
Hyperglycemia
33%
Delayed Graft Function Requiring Dialysis
30%
Diarrhea
30%
Nausea
28%
Headache
28%
Hypertension
25%
Tremor
25%
Infection
23%
Constipation
23%
Edema
20%
Vomiting
18%
Hyperlipidemia
18%
Hypokalemia
10%
Biopsy Proven Acute Rejection
8%
Neurotoxicity
3%
Graft loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
CYP3A5 Based Tacrolimus Dosing
Control

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
913 Previous Clinical Trials
390,339 Total Patients Enrolled
2 Trials studying Kidney Failure
315 Patients Enrolled for Kidney Failure

Media Library

Envarsus Oral Product (Immunosuppressant) Clinical Trial Eligibility Overview. Trial Name: NCT05242315 — Phase 4
Kidney Failure Research Study Groups: Envarsus, Prograf (SOC)
Kidney Failure 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
~22 spots leftby Jul 2025
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