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RECRUITING
NCT05242315
PHASE4

Extended-Release Tacrolimus Following Liver Transplantation

Sponsor: University of Alberta

View on ClinicalTrials.gov

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.

Official title: Feasibility, Efficacy And Safety Of De Novo Extended-Release Tacrolimus Following Liver Transplantation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

94

Start Date

2022-05-15

Completion Date

2034-02-15

Last Updated

2025-08-21

Healthy Volunteers

No

Interventions

DRUG

Envarsus Oral Product

as described in arm/group description

DRUG

Prograf (SOC)

Prograf (SOC)

Locations (1)

Univerity of Alberta

Edmonton, Alberta, Canada