Improving Medication Adherence in Adolescents Who Had a Liver Transplant

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 28, 2018

First Posted Date ^ICMJE

October 1, 2018

Last Update Posted Date

October 1, 2018

Actual Study Start Date ^ICMJE

October 1, 2018

Estimated Primary Completion Date

September 30, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Incidence of Rejection[ Time Frame: 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.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

The Standard Deviation of A Series Of Tacrolimus Levels (MLVI)[ Time Frame: 2 Years ]
MLVI = Standard Deviation Of Tacrolimus Blood Levels
Incidence of Locally Determined Biopsy Proven Rejection[ Time Frame: 2 Years ]
Rate Of Locally Determined Biopsy Proven Rejection[ Time Frame: 2 Years ]
Rate of Centrally Determined Biopsy Proven Rejection[ Time Frame: 2 Years ]
Time to Rejection From Enrollment[ Time Frame: 2 Years ]
Occurrence of Death[ Time Frame: 2 Years ]
Number of deaths
Occurrence of Re-Listing For Transplantation[ Time Frame: 2 Years ]
Number of participants listing for retransplantation
Mean ALT[ Time Frame: 2 Years ]
Mean number of achieving above threshold ALT > 150 Alanine Aminotransferase (ALT)
Mean maximal ALT[ Time Frame: 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[ Time Frame: 2 Years ]
Mean number of achieving above threshold GGT > 150 Gamma Glutamyl Transferase (gGT)
Mean maximal gGT[ Time Frame: 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)

Descriptive Information

Brief Title ^ICMJE

Improving Medication Adherence in Adolescents Who Had a Liver Transplant

Official Title ^ICMJE

Improving Medication Adherence in Adolescents Who Had a Liver Transplant

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 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.

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Study participants will be randomized to receive the telemetric intervention or standard of care.
Masking: Interventional
Masking Description:Study pathologists will perform masked reading of for-cause biopsy slides.
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Behavioral: Telemetric Intervention
Calls, scripted by a manual; the frequency of the calls varies with patient's MLVI status and preferences.

Study Arms

Experimental: Telemetric Intervention Arm
Adolescent with MLVI>2 to receive the telemetric intervention.
No Intervention: Standard of Care Arm
Adolescent with MLVI>2 to receive standard of care.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

156

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

September 30, 2023

Estimated Primary Completion Date

September 30, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: - 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 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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

12 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Canada|United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Icahn School of Medicine at Mount Sinai

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Eyal Shemesh, MD Icahn School of Medicine at Mount Sinai

PRS Account

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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