This study is in progress, not accepting new patients

Improving Medication Adherence in Adolescents Who Had a Liver Transplant

a study on Transplants Liver Transplant

Summary

Eligibility
for people ages 12-19 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

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).

Details

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.

Keywords

Transplant, Intervention, Adherence, Telemetric Intervention

Eligibility

You can join if…

Open to people ages 12-19

  • The patient is ≥ 12 and < 20 years of age at enrollment.
  • ≥2.5 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

You CAN'T join if...

  • 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.

Locations

  • Benioff Children's Hospital UCSF
    San Francisco California 94107 United States
  • Children's Hospital Los Angeles
    Los Angeles California 90027 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Icahn School of Medicine at Mount Sinai
Links
Official Website of The iMALT Study
ID
NCT03691220
Study Type
Interventional
Participants
About 148 people participating
Last Updated