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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
148
Calls, scripted by a manual; the frequency of the calls varies with patient's MLVI status and preferences.
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
Incidence of Rejection
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.
Time frame: 2 Years
The Standard Deviation of A Series Of Tacrolimus Levels (MLVI)
MLVI = Standard Deviation Of Tacrolimus Blood Levels
Time frame: 2 Years
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
Number of deaths
Time frame: 2 Years
Occurrence of Re-Listing For Transplantation
Number of participants listing for retransplantation
Time frame: 2 Years
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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
...and 3 more locations
Mean ALT
Mean number of achieving above threshold ALT \> 150 Alanine Aminotransferase (ALT)
Time frame: 2 Years
Mean maximal ALT
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)
Time frame: 2 Years
Mean gGT
Mean number of achieving above threshold GGT \> 150 Gamma Glutamyl Transferase (gGT)
Time frame: 2 Years
Mean maximal gGT
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 frame: 2 Years