Improving Medication Adherence in Adolescents Who Had a Liver Transplant

Not Applicable

Active, not recruiting

• Conditions: Transplant
• Interventions: Behavioral: Telemetric Intervention

• Registration Number: NCT03691220
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief 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).

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-09-28
• Study First Submitted QC: 2018-09-28
• Study First Posted: 2018-10-01
• Study Start: 2018-11-14
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-26
• Last Update Posted: 2024-10-29
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

• 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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telemetric Intervention Arm	Telemetric Intervention	Adolescent with MLVI\>2 to receive the telemetric intervention.

Primary Outcome Measures

Name	Time	Method
Incidence of Rejection	2 Years	The incidence of biopsy-proven acute cellular rejection (number of patients experiencing at least one episode of rejection) at any time during the 2 years of follow up.Biopsy-confirmed late acute rejection, as determined by the majority of 3 masked readings of liver biopsy images by 3 pathologists that are not from the clinical site at which the patient is treated. Patients with incomplete follow-up (for example due to death, re-transplant, listing for re-transplantation), will be assumed to have experienced a rejection for the purpose of the primary analysis.

Secondary Outcome Measures

Name	Time	Method
Rate of Centrally Determined Biopsy Proven Rejection	2 Years
Rate Of Locally Determined Biopsy Proven Rejection	2 Years
The Standard Deviation of A Series Of Tacrolimus Levels (MLVI)	2 Years	MLVI = Standard Deviation Of Tacrolimus Blood Levels
Incidence of Locally Determined Biopsy Proven Rejection	2 Years
Mean ALT	2 Years	Mean number of achieving above threshold ALT \> 150 Alanine Aminotransferase (ALT)
Mean maximal ALT	2 Years	mean/maximal and ALT (defined as in MALT as the mean of all levels recorded during the study period and the maximal level recorded during the study period)
Mean gGT	2 Years	Mean number of achieving above threshold GGT \> 150 Gamma Glutamyl Transferase (gGT)
Mean maximal gGT	2 Years	mean/maximal gGT (defined as in MALT as the mean of all levels recorded during the study period and the maximal level recorded during the study period)
Time to Rejection From Enrollment	2 Years
Occurrence of Death	2 Years	Number of deaths
Occurrence of Re-Listing For Transplantation	2 Years	Number of participants listing for retransplantation

Trial Locations

Locations (13)

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States

Mattel Children's Hospital UCLA; 🇺🇸 Los Angeles, 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

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Texas Children's Hospital; 🇺🇸 Houston, Texas, United States

The Hospital For Sick Children Toronto; 🇨🇦 Toronto, Ontario, Canada

Children's Hospital of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

Benioff Children's Hospital UCSF; 🇺🇸 San Francisco, California, United States

C.S.Mott Children's Hospital; 🇺🇸 Ann Arbor, Michigan, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States