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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-10 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety of Envarsus as indicated by adverse events
Secondary outcome measures
Graft Survival
Impact on quality of life (QOL) - Chronic Liver Disease Questionnaire
Impact on quality of life (QOL) - EuroQuol Visual Analogue Scale (VAS)
+10 moreSide effects data
From 2022 Phase 4 trial • 97 Patients • NCT0302058998%
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
889 Previous Clinical Trials
385,040 Total Patients Enrolled
2 Trials studying Kidney Failure
315 Patients Enrolled for Kidney Failure
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have congenital long QT syndrome.I need a new organ transplant or multiple organ transplants.I stopped taking calcineurin inhibitors due to acute kidney injury.Adults who have received a transplant at the University of Alberta.My kidney function is low (eGFR < 45).Your bilirubin levels are very high after liver transplant.
Research Study Groups:
This trial has the following groups:- Group 1: Envarsus
- Group 2: Prograf (SOC)
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this clinical experiment have any open enrollment slots?
"The trial is currently recruiting; the information was first posted on May 15th 2022 and last updated on February 3rd 2023, according to clinicaltrials.gov."
Answered by AI
What adverse impacts does Envarsus potentially have on patients?
"Due to its fourth phase of clinical trials, Envarsus has been granted a safety score of 3 out of 3."
Answered by AI
How many participants have joined this clinical investigation?
"Absolutely. Per clinicaltrials.gov, recruitment for this medical experiment is ongoing since its initial posting on May 15th 2022 and the most recent update which occurred on February 3rd 2023. A total of 94 volunteers are in search from just one location."
Answered by AI
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