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| ID | Type | Description | Link |
|---|---|---|---|
| U01DK119200 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of California, Los Angeles | OTHER |
| Ann & Robert H Lurie Children's Hospital of Chicago | OTHER |
| Baylor College of Medicine | OTHER |
| University of Pittsburgh |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemetric Intervention Arm | Experimental | Adolescent with MLVI>2 to receive the telemetric intervention. |
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| Standard of Care Arm | No Intervention | Adolescent with MLVI>2 to receive standard of care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemetric Intervention | Behavioral | Calls, scripted by a manual; the frequency of the calls varies with patient's MLVI status and preferences. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 Years |
| Measure | Description | Time Frame |
|---|---|---|
| The Standard Deviation of A Series Of Tacrolimus Levels (MLVI) | MLVI = Standard Deviation Of Tacrolimus Blood Levels | 2 Years |
| Incidence of Locally Determined Biopsy Proven Rejection | 2 Years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eyal Shemesh, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | United States | ||
| Mattel Children's Hospital UCLA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42208859 | Derived | Shemesh E, Anand R, Annunziato RA, Fredericks EM, Garcia J, Gupta NA, Kleinman LC, Kriegermeier A, Mysore KR, Ng VL, Lobritto SJ, Patel S, Perito ER, Rand EB, Romero R, Venick RS, Duncan-Park S, Mitchell J, Anderson SG, Stuber ML, Reyes-Mugica M, Mazariegos GV, Shneider BL. A remote intervention to improve medication nonadherence guided by a marker of risk derived from the electronic health records of adolescent transplant recipients. Am J Transplant. 2026 May 27:S1600-6135(26)00238-8. doi: 10.1016/j.ajt.2026.04.030. Online ahead of print. | |
| 40465085 |
| Label | URL |
|---|---|
| Official Website of The iMALT Study | View source |
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| OTHER |
| University of California, San Francisco | OTHER |
| Children's Hospital of Michigan | OTHER |
| Children's Hospital of Philadelphia | OTHER |
| Emory-Children's Center | OTHER |
| The Hospital for Sick Children | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Columbia University | OTHER |
| Seattle Children's Hospital | OTHER |
| University of Miami | OTHER |
| Children's Hospital Los Angeles | OTHER |
Study participants will be randomized to receive the telemetric intervention or standard of care.
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Study pathologists will perform masked reading of for-cause biopsy slides.
| 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 | Number of deaths | 2 Years |
| Occurrence of Re-Listing For Transplantation | Number of participants listing for retransplantation | 2 Years |
| Mean ALT | Mean number of achieving above threshold ALT > 150 Alanine Aminotransferase (ALT) | 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) | 2 Years |
| Mean gGT | Mean number of achieving above threshold GGT > 150 Gamma Glutamyl Transferase (gGT) | 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) | 2 Years |
| Los Angeles |
| California |
| 90095 |
| United States |
| Benioff Children's Hospital UCSF | San Francisco | California | 94107 | United States |
| Miami Transplant Institute | Miami | Florida | 33136 | United States |
| Children's Healthcare of Atlanta/Emory | Atlanta | Georgia | 30322 | United States |
| Lurie Children's Hospital | Chicago | Illinois | 60611 | United States |
| C.S.Mott Children's Hospital | Ann Arbor | Michigan | 48109 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | United States |
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
| The Hospital For Sick Children Toronto | Toronto | Ontario | M5G1X8 | Canada |
| Derived |
| Tutino R, Annunziato R, Dunphy C, Anand R, Mitchell J, Stuber M, Shemesh E, Duncan-Park S; for iMALT. Development of a Targeted, Telehealth Intervention: Experiences From the Improving Medication Adherence in Adolescents and Young Adults Following a Liver Transplantation (iMALT) Multisite Trial. Pediatr Transplant. 2025 Aug;29(5):e70109. doi: 10.1111/petr.70109. |
| 36094829 | Derived | Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2. |