Improving Medication Adherence in Adolescents Who Had a Liver Transplant

  • End date
    Sep 30, 2023
  • participants needed
  • sponsor
    Icahn School of Medicine at Mount Sinai
Updated on 29 July 2021
liver transplant


The study's aim is to test a tailored telemetric intervention to reduce rejection incidence by improving medication adherence in a group of adolescent liver transplant recipients identified as nonadherent by a marker (the Medication Level Variability Index, MLVI).


This is a prospective, multi-center, randomized controlled trial. The study will be conducted in transplant centers in the United States and Canada. Estimated final sample size of 140 after attrition. Pediatric adolescent and young adult (age at enrollment 12 and < 20) transplant recipients will be eligible for participation in the study. Eligible participants will be randomly assigned to intervention or control group. An interim analysis to evaluate efficacy will be performed. Missing data will not be imputed for secondary analyses.

Condition Graft, Transplantation, transplant, grafting procedure, transplant procedure
Treatment Telemetric Intervention
Clinical Study IdentifierNCT03691220
SponsorIcahn School of Medicine at Mount Sinai
Last Modified on29 July 2021


Yes No Not Sure

Inclusion Criteria

The patient is 12 and < 20 years of age at enrollment
5 years after last liver transplantation
Guardian's consent, adolescent assent at enrollment
The patient is prescribed tacrolimus
The patient's MLVI (SD of tacrolimus) was > 2 when calculated by the site for a period of 2 years prior to the review date

Exclusion Criteria

The patient has had transplant of an organ other than liver
The patient is currently listed for any organ transplantation
The patient is expected to transition to another service (e.g., adult clinic, another
hospital) during the two years of the study
Pregnant patients
A temporary exclusion: the patient is not medically stable or was hospitalized for >48 consecutive hours in the past three months
Site PI, study PI, or Medical Monitor determines that the patient should not be a candidate for the intervention due to factors that are not covered in the above criteria
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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