Extended-Release Tacrolimus Following Liver Transplantation

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alberta

About this trial

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.

Eligibility criteria

Qualifiers

None

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Envarsus Oral Product
  • Prograf (SOC)

Treatment groups

94 Participants
are divided into 2 treatment groups

Sponsors and collaborators