Recruiting

Tacrolimus

Sponsor:

University of Alberta

Code:

NCT05242315

Conditions

Liver Transplant; Complications

Renal Insufficiency

Immunosuppressant Adverse Reaction

Metabolic Syndrome

Cardiovascular Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Envarsus Oral Product

Prograf (SOC)

Study Details

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

Study ID

NCT05242315

Start date

May 15, 2022

Status verified date

Aug, 2025

Completion date

Feb 15, 2034

Anticipated

Primary completion date

Dec 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

\- Adult individuals transplanted at the University of Alberta

Exclusion Criteria:

  • 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

Study Design

Enrollment

94 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Envarsus

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

other: Prograf (SOC)

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

Interventions

Envarsus Oral Product

as described in arm/group description

Prograf (SOC)

Prograf (SOC)

Primary outcome measure

  • Safety of Envarsus as indicated by adverse events [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Rahima A Bhanji, MD

780-492-2235rbhanji@ualberta.ca

Nadia Shular, RN

587-588-7231nadiashular@ualberta.ca

Locations

Univerity of Alberta

Recruiting

Edmonton, Alberta, Canada, T6G 2R3

Contacts

Rahima Bhanji, MD

780-492-2235rbhanji@ualberta.ca

Principal Investigator:

Rahima Bhanji, MD

More Information

Sponsor

University of Alberta

Last update posted

Aug 21, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Alberta on 2025-08-21.