Migliorare l'aderenza ai farmaci negli adolescenti che hanno avuto un trapianto di fegato (iMALT)
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).
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Ontario
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Toronto, Ontario, Canada, M5G1X8
- The Hospital For Sick Children Toronto
-
-
-
-
California
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Los Angeles, California, Stati Uniti, 90027
- Children's Hospital Los Angeles
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Los Angeles, California, Stati Uniti, 90095
- Mattel Children's Hospital UCLA
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San Francisco, California, Stati Uniti, 94107
- Benioff Children's Hospital UCSF
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Florida
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Miami, Florida, Stati Uniti, 33136
- Miami Transplant Institute
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Georgia
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Atlanta, Georgia, Stati Uniti, 30322
- Children's Healthcare of Atlanta/Emory
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Illinois
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Chicago, Illinois, Stati Uniti, 60611
- Lurie Children's Hospital
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Michigan
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Ann Arbor, Michigan, Stati Uniti, 48109
- C.S.Mott Children's Hospital
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New York
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New York, New York, Stati Uniti, 10032
- Columbia University Medical Center
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New York, New York, Stati Uniti, 10029
- Icahn School of Medicine at Mount Sinai
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti, 19104
- Children's Hospital of Philadelphia
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Pittsburgh, Pennsylvania, Stati Uniti, 15224
- Children's Hospital of Pittsburgh
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Texas
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Houston, Texas, Stati Uniti, 77030
- Texas Children's Hospital
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Telemetric Intervention Arm
Adolescent with MLVI>2 to receive the telemetric intervention. |
Calls, scripted by a manual; the frequency of the calls varies with patient's MLVI status and preferences. |
|
Nessun intervento: Standard of Care Arm
Adolescent with MLVI>2 to receive standard of care. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of Participants Experiencing at Least One Episode of Rejection
Lasso di tempo: 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), was assumed to have experienced a rejection for the purpose of the primary analysis. |
2 Years
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
The Standard Deviation of A Series Of Tacrolimus Levels (MLVI)
Lasso di tempo: 2 Years
|
Medication level variability index (MLVI) score is defined as the Standard Deviation (SD) Of Tacrolimus Blood Levels over time during follow-up. MLVI identifies medication-taking behavior. A higher SD indicates less consistent adherence. |
2 Years
|
|
Number of Participants With Locally and Centrally Determined Rejection by Biopsy
Lasso di tempo: 2 Years
|
Number of Participants with Locally and Centrally Determined Rejection Biopsy Proven Rejection |
2 Years
|
|
Number of Locally Determined Rejections by Biopsy Per Patient During Follow-up
Lasso di tempo: 2 Years
|
Rate Of Locally Determined Biopsy Proven Rejection determined by Number of locally determined rejections by biopsy per patient during follow-up |
2 Years
|
|
Time to First Locally Rejection From Enrollment
Lasso di tempo: about 12 months
|
Time to first locally determined rejection by biopsy from enrollment |
about 12 months
|
|
Time to First Centrally Determined Rejection
Lasso di tempo: up to 12 months
|
Time, in months, to first centrally determined rejection by biopsy from enrollment |
up to 12 months
|
|
Occurrence of Death
Lasso di tempo: 2 Years
|
Number of deaths |
2 Years
|
|
Occurrence of Re-Listing For Transplantation
Lasso di tempo: 2 Years
|
Number of participants listing for retransplantation |
2 Years
|
|
Number of Participants With ALT >150 U/L
Lasso di tempo: 2 Years
|
Number of Participants achieving above the predetermined threshold alanine trans aminase (ALT) > 150 |
2 Years
|
|
Mean and Maximal ALT Level
Lasso di tempo: 2 Years
|
mean and maximal 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
|
|
Number of Participants Achieving Mean GGT > 150
Lasso di tempo: 2 Years
|
Number of participants achieving mean number above threshold GGT > 150 Gamma Glutamyl Transferase (gGT) |
2 Years
|
|
Mean and Maximal gGT
Lasso di tempo: 2 Years
|
mean and 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
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Eyal Shemesh, MD, Icahn School of Medicine at Mount Sinai
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
- 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 Sep;26(9):2099-2110. doi: 10.1016/j.ajt.2026.04.030. Epub 2026 May 27.
- 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.
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- GCO 18-0061
- U01DK119200 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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