Summary

for people ages 12-17 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Emily Perito

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 11 transplant centers in the United States and Canada. Estimated final sample size of 140. Pediatric adolescent and young adult (age at enrollment ≥12 and < 18) 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 12-17

  • The patient is ≥ 12 and < 18 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 not yet accepting patients
    San Francisco California 94107 United States
  • Mattel Children's Hospital UCLA not yet accepting patients
    Los Angeles California 90095 United States

Details

Status
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
Lead Scientist
Emily Perito
Study Type
Interventional
Last Updated