Transplant
Conditions
Keywords
Intervention, Adherence
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.
Interventions
BEHAVIORALTelemetric Intervention
Calls, scripted by a manual; the frequency of the calls varies with patient's MLVI status and preferences.
Sponsors
University of California, Los Angeles
Ann & Robert H Lurie Children's Hospital of Chicago
Baylor College of Medicine
University of Pittsburgh
University of California, San Francisco
Children's Hospital of Michigan
Children's Hospital of Philadelphia
Emory-Children's Center
The Hospital for Sick Children
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Columbia University
Seattle Children's Hospital
University of Miami
Children's Hospital Los Angeles
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Study pathologists will perform masked reading of for-cause biopsy slides.
Intervention model description
Study participants will be randomized to receive the telemetric intervention or standard of care.
Eligibility
Sex/Gender
ALL
Age
12 Years to 19 Years
Healthy volunteers
No
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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Locally Determined Biopsy Proven Rejection | 2 Years | — |
| Rate Of Locally Determined Biopsy Proven Rejection | 2 Years | — |
| Rate of Centrally Determined Biopsy Proven Rejection | 2 Years | — |
| Time to Rejection From Enrollment | 2 Years | — |
| Occurrence of Death | 2 Years | Number of deaths |
| The Standard Deviation of A Series Of Tacrolimus Levels (MLVI) | 2 Years | MLVI = Standard Deviation Of Tacrolimus Blood Levels |
| 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) |
| Occurrence of Re-Listing For Transplantation | 2 Years | Number of participants listing for retransplantation |
Countries
Canada, United States
Outcome results
None listed