Tacrolimus Formulations for Tremors in Liver Transplant Patients (LCP-TAC Trial)

Phase 4

Recruiting

Led By Trana Hussaini, Pharm D

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All patients who are eligible to initiate Tacrolimus within 7 days post-liver transplant

Recipients of a first-time liver transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3, 6 and 12 months post transplantation

Awards & highlights

All Individual Drugs Already Approved

Pivotal Trial

Approved for 5 Other Conditions

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial is studying the risk of tremors in liver transplant patients who take two different forms of a medication called tacrolimus. One form is taken once a day and the other is taken twice a

Who is the study for?

This trial is for adults over 18 who've just had their first liver transplant and have a kidney function (eGFR) above 30 ml/min. They should be starting on Tacrolimus within 7 days after the transplant and must give informed consent to participate.

What is being tested?

The study compares two forms of Tacrolimus in new liver transplant recipients: Envarsus, an extended-release tablet taken once daily, versus a twice-daily immediate-release version. The goal is to see which causes fewer tremors.

What are the potential side effects?

Tacrolimus may cause side effects like shaking hands (tremors), headaches, diarrhea, high blood pressure, changes in kidney function, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can start Tacrolimus within a week after my liver transplant.

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I have received a liver transplant for the first time.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3, 6 and 12 months post transplantation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3, 6 and 12 months post transplantation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6 and 12 months post transplantation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of patients with tacrolimus induced tremors or worsening tremors or tacrolimus discontinuation due to neurotoxicity at 8 weeks post transplantation

Secondary study objectives

Immunosuppression medication adherence as assessed by the Simplified Medication Adherence Questionnaire (SMAQ) at 12 months after transplant

Immunosuppression medication adherence as assessed by the Simplified Medication Adherence Questionnaire (SMAQ) at 8 weeks after transplant

Proportion of patients reaching the composite end point of death, graft loss or biopsy proven acute cellular rejection (BPAR) at 12 months post transplantation

+1 more

Other study objectives

Change in GFR

Incidence and severity of AKI

Incidence of biopsy proven acute cellular rejection (BPAR)

+3 more