Extended-Release Tacrolimus Following Liver Transplantation

NCT05242315 | Recruiting Phase 4

• 1 other identifier: Pro00105029
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

Medications used after transplant to prevent rejection are associated with many side effects. Tacrolimus side effects include kidney dysfunction; tremor, headaches, difficulty sleeping, change in sensation (legs), seizure, or confusion; high blood pressure; anemia, or low blood cell counts; diabetes; abnormal cholesterol and weight gain. The investigators want to use a new, approved, formulation of the standard medication (Envarsus) as they believe it may be associated with reduced side effects. The investigators would like to assess how safe it is to use this medication and how well it works in comparison to currently used formulations. The investigators will study if there are less side effects and will study clinical outcomes (including how well the liver does and if there is need for hospitalizations after transplant). The investigators hope that this information will improve the care provided to and outcomes in patients following liver transplant.

Conditions

Liver Transplant; Complications; Renal Insufficiency; Immunosuppressant Adverse Reaction; Metabolic Syndrome; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Safety of Envarsus as indicated by adverse events

  Adverse events include frequency of transplant rejection, and changes from baseline in clinical laboratory parameters

  1 year

Secondary Outcomes (13)

• Incidence of renal impairment

  1-10 years

• Number of patients with metabolic syndromes [diabetes]

  1-10 years

• Incidence of neurotoxicity

  1 years

• Length of stay in hospitalized patients

  1-10 years

• Incidence of Intensive Care Unit (ICU) admission

  1-10 years

Study Arms (2)

Envarsus

ACTIVE COMPARATOR

Envarsus tablet Dose 0.11 - 0.13 mg/Kg/day Frequency: once per day

Drug: Envarsus Oral Product

Prograf (SOC)

OTHER

Prograf tablet Dose 0.10 - 0.15mg/Kg daily Frequency: 2 doses per day (dose above split in half for each dose)

Drug: Prograf (SOC)

Interventions

Envarsus Oral Product DRUG

as described in arm/group description

Envarsus

Prograf (SOC) DRUG

Prograf (SOC)

Prograf (SOC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Adult individuals transplanted at the University of Alberta

You may not qualify if:

• Individuals with congenital long QT syndrome
• Patients with elevated bilirubin \> 100 umol/L post-LT (at day 3)
• Patients with chronic kidney disease (eGFR \< 45 ml per minute per 1.73 m2)
• Patients with acute kidney injury requiring discontinuation of calcineurin inhibitors.
• Patients who have hepatocellular carcinoma, require a re-transplant, or receive multi-visceral transplant

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Univerity of Alberta

Edmonton, Alberta, T6G 2R3, Canada

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency; Metabolic Syndrome; Cardiovascular Diseases

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Central Study Contacts

Rahima A Bhanji, MD

CONTACT

780-492-2235; rbhanji@ualberta.ca

Nadia Shular, RN

CONTACT

587-588-7231; nadiashular@ualberta.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: February 16, 2022
• Study Start: May 15, 2022
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): February 15, 2034
• Last Updated: August 21, 2025

Record last verified: 2025-08

Locations

CA (1)