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Extended-Release Tacrolimus Following Liver Transplantation

StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Secondary endpoints: details revised at 7 of 13 entries
    • Study description revised
    • Eligibility criteria expanded, about 5 words
  2. Primary completion date: Jul 15, 2025 to Dec 15, 2026v9
  3. Study description expanded, about 13 words
    • Eligibility criteria expanded, about 3 words
    v8
  4. Primary completion date: Feb 15, 2024 to Jul 15, 2025v7
  5. Re-verified, no change to tracked fieldsv6
Show 4 earlier versionsHide 4 earlier versions
  1. Primary completion date: Feb 15, 2023 to Feb 15, 2024
    • Study completion date: Feb 15, 2033 to Feb 15, 2034
    v5
  2. Trial status: Suspended to Recruiting
    • Site details revised
    v4
  3. Trial status: Not Yet Recruiting to Suspended Sponsor's reason: Study on hold.
    • Site contact updated
    v3
  4. Start date: Feb 15, 2022 to May 15, 2022v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05242315
Lead Sponsor University of Alberta
Conditions
(from sponsor)		 Liver Transplant; Complications, Renal Insufficiency, Immunosuppressant Adverse Reaction, Metabolic Syndrome, Cardiovascular Diseases
Related terms Cardiovascular Diseases, Metabolic Syndrome, Renal Insufficiency
Enrollment 94 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov