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Immunosuppressant

LCPT for Immunosuppression (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

LCP-TAC Trial 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.Check my eligibility

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.See study design

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.

LCP-TAC Trial 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.

LCP-TAC Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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 outcome measures

Change in GFR

Incidence and severity of AKI

Incidence of biopsy proven acute cellular rejection (BPAR)

+3 more

Side effects data

From 2022 Phase 4 trial • 97 Patients • NCT03020589

98%

Anemia

83%

Hypomagnesemia

75%

Leukopenia

70%

Hyperkalemia

57%

Abnormal renal function

50%

Hypophosphatemia

50%

Increase creatinine

45%

Hyperglycemia

33%

Delayed Graft Function Requiring Dialysis

30%

Diarrhea

30%

Nausea

28%

Headache

28%

Hypertension

25%

Tremor

25%

Infection

23%

Constipation

23%

Edema

20%

Vomiting

18%

Hyperlipidemia

18%

Hypokalemia

10%

Biopsy Proven Acute Rejection

Neurotoxicity

Graft loss

100%

80%

60%

40%

20%

Study treatment Arm

CYP3A5 Based Tacrolimus Dosing

Control

LCP-TAC Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: LCPTExperimental Treatment1 Intervention

Group II: IR-TACActive Control1 Intervention

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Paladin Labs Inc.OTHER

3 Previous Clinical Trials

231 Total Patients Enrolled

University of British ColumbiaLead Sponsor

1,418 Previous Clinical Trials

2,466,994 Total Patients Enrolled

Jo-Ann Ford, RNStudy ChairUniversity of British Columbia

1 Previous Clinical Trials

24 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants still eligible to enroll in this ongoing clinical trial?

"Indeed, as stated on clinicaltrials.gov, this clinical trial is presently accepting patient enrollments. The initial posting of the trial occurred on January 9th, 2023 and it was last modified on December 27th, 2023."

Answered by AI

What is the number of participants currently enrolled in this clinical study?

"Indeed, as indicated on clinicaltrials.gov, this ongoing trial is actively seeking eligible participants. The initial posting of the trial was on January 9th, 2023 and it was last updated on December 27th, 2023. The study aims to enroll a total of 124 patients from one designated site."

Answered by AI