Improving Medication Adherence in Adolescents Who Had a Liver Transplant
Overview
- Phase
- N/A
- Intervention
- Telemetric Intervention
- Conditions
- Transplant
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Enrollment
- 148
- Locations
- 18
- Primary Endpoint
- Incidence of Rejection
- Status
- Completed
- Last Updated
- 3 months ago
Overview
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.
Investigators
Eyal Shemesh
Professor
Icahn School of Medicine at Mount Sinai
Eligibility Criteria
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.
Arms & Interventions
Telemetric Intervention Arm
Adolescent with MLVI\>2 to receive the telemetric intervention.
Intervention: Telemetric Intervention
Standard of Care Arm
Adolescent with MLVI\>2 to receive standard of care.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)
- Incidence of Locally Determined Biopsy Proven Rejection(2 Years)
- Mean ALT(2 Years)
- Mean maximal ALT(2 Years)
- Mean gGT(2 Years)
- Mean maximal gGT(2 Years)
- Time to Rejection From Enrollment(2 Years)
- Occurrence of Death(2 Years)
- Occurrence of Re-Listing For Transplantation(2 Years)