Recruiting

Tacrolimus vs. Extended-Release

Sponsor:

University of British Columbia

Code:

NCT05089604

Conditions

Liver Transplantation

Immunosuppression

Neurotoxicity

Tremor

Tacrolimus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tacrolimus, Immediate Release, Oral

Tacrolimus Extended Release Oral Tablet

Study Details

Brief summary:

This is a randomized open label study in de novo liver transplant recipients that aims to compare the risk of tacrolimus induced tremors with once daily extended-release formulation, Envarsus, versus the twice daily immediate-release formulation. Both formulations of tacrolimus are currently approved for the prevention of rejection in liver transplant patients.

Conditions

Liver Transplantation

Immunosuppression

Neurotoxicity

Tremor

Tacrolimus

Study ID

NCT05089604

Start date

Jan 9, 2023

Status verified date

Dec, 2023

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Jan 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Adults aged 18 years or older
2. Recipients of a first-time liver transplant
3. eGFR more than 30 ml/min on the day of tacrolimus initiation
4. All patients who are eligible to initiate Tacrolimus within 7 days post-liver transplant
5. Informed consent

Exclusion Criteria:

1. Recipients of prior organ transplant
2. Need for hemodialysis either prior or following liver transplantation
3. Recipients of living donor liver or split deceased donor liver allografts
4. Recipients of combined liver/kidney transplants
5. Recipients receiving liver allografts from donors with HCV viremia (detected through nucleic acid testing or other means)
6. Patients with a history of tremor prior to transplantation including essential tremors, Parkinson's or Parkinsonian syndromes
7. Patients receiving concomitant medications known to induce tremors such as dopamine blocking agents
8. Baseline TSH, T3, T4 indicating hyperthyroidism

Study Design

Enrollment

124 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: LCPT

active comparator: IR-TAC

Interventions

Tacrolimus, Immediate Release, Oral

Twice Daily Tacrolimus

Tacrolimus Extended Release Oral Tablet

Once Daily Tacrolimus

Primary outcome measure

  • Proportion of patients with tacrolimus induced tremors or worsening tremors or tacrolimus discontinuation due to neurotoxicity at 8 weeks post transplantation [ Time Frame: 8 weeks post transplantation ]

Central Contacts and Locations

Central contacts

Trana Hussaini

6043284930trana.hussaini@vch.ca

Eric Yoshida, MD

604-872-9858eric.yoshida@vch.ca

Locations

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Contacts

Trana Hussaini

6043284930trana.hussaini@vch.ca

Jo-Ann Ford

jo-ann.ford@vch.ca

More Information

Sponsor

University of British Columbia

Last update posted

Jan 2, 2024

Last verified

Dec, 2023

Keywords

  • Liver Transplant
  • Tacrolimus
  • Immunosuppression
  • Tremor
  • Envarsus
  • LCP-TAC
  • Neurotoxicity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2024-01-02.