Improving Medication Adherence in Adolescents Who Had a Liver Transplant

Completed · Not applicable

Conditions studied: Transplant

In brief

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).

Key facts

Study ID

NCT03691220

Run by

Icahn School of Medicine at Mount Sinai

People needed

148

Starts

2018-11-14

Expected to finish

2025-10-22

Last updated by the study team

2026-01-07

Who can join

Age: 12 and older, up to 19. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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.

Where it is running

• Children's Hospital Los Angeles — Los Angeles, California, United States
• Mattel Children's Hospital UCLA — Los Angeles, California, United States
• Benioff Children's Hospital UCSF — San Francisco, California, United States
• Miami Transplant Institute — Miami, Florida, United States
• Children's Healthcare of Atlanta/Emory — Atlanta, Georgia, United States
• Lurie Children's Hospital — Chicago, Illinois, United States
• C.S.Mott Children's Hospital — Ann Arbor, Michigan, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Texas Children's Hospital — Houston, Texas, United States
• The Hospital For Sick Children Toronto — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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