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Extended-Release Tacrolimus Following Liver Transplantation

NCT05242315 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2025-08-21

No results posted yet for this study

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

Interventions

DRUG

Envarsus Oral Product

as described in arm/group description

DRUG

Prograf (SOC)

Prograf (SOC)

Sponsors & Collaborators

  • University of Alberta

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-15
Primary Completion
2026-12-15
Completion
2034-02-15

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05242315 on ClinicalTrials.gov