Verbesserung der Medikamentenadhärenz bei Jugendlichen, die eine Lebertransplantation hatten (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).
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Ontario
-
Toronto, Ontario, Kanada, M5G1X8
- The Hospital For Sick Children Toronto
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-
-
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California
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Los Angeles, California, Vereinigte Staaten, 90027
- Children's Hospital Los Angeles
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Los Angeles, California, Vereinigte Staaten, 90095
- Mattel Children's Hospital UCLA
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San Francisco, California, Vereinigte Staaten, 94107
- Benioff Children's Hospital UCSF
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Florida
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Miami, Florida, Vereinigte Staaten, 33136
- Miami Transplant Institute
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Georgia
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Atlanta, Georgia, Vereinigte Staaten, 30322
- Children's Healthcare of Atlanta/Emory
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Illinois
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Chicago, Illinois, Vereinigte Staaten, 60611
- Lurie Children's Hospital
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Michigan
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Ann Arbor, Michigan, Vereinigte Staaten, 48109
- C.S.Mott Children's Hospital
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New York
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New York, New York, Vereinigte Staaten, 10032
- Columbia University Medical Center
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New York, New York, Vereinigte Staaten, 10029
- Icahn School of Medicine at Mount Sinai
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Pennsylvania
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
- Children's Hospital of Philadelphia
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Pittsburgh, Pennsylvania, Vereinigte Staaten, 15224
- Children's Hospital of Pittsburgh
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Texas
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Houston, Texas, Vereinigte Staaten, 77030
- Texas Children's Hospital
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-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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. |
|
Kein Eingriff: Standard of Care Arm
Adolescent with MLVI>2 to receive standard of care. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of Participants Experiencing at Least One Episode of Rejection
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
The Standard Deviation of A Series Of Tacrolimus Levels (MLVI)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: about 12 months
|
Time to first locally determined rejection by biopsy from enrollment |
about 12 months
|
|
Time to First Centrally Determined Rejection
Zeitfenster: up to 12 months
|
Time, in months, to first centrally determined rejection by biopsy from enrollment |
up to 12 months
|
|
Occurrence of Death
Zeitfenster: 2 Years
|
Number of deaths |
2 Years
|
|
Occurrence of Re-Listing For Transplantation
Zeitfenster: 2 Years
|
Number of participants listing for retransplantation |
2 Years
|
|
Number of Participants With ALT >150 U/L
Zeitfenster: 2 Years
|
Number of Participants achieving above the predetermined threshold alanine trans aminase (ALT) > 150 |
2 Years
|
|
Mean and Maximal ALT Level
Zeitfenster: 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
Zeitfenster: 2 Years
|
Number of participants achieving mean number above threshold GGT > 150 Gamma Glutamyl Transferase (gGT) |
2 Years
|
|
Mean and Maximal gGT
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Eyal Shemesh, MD, Icahn School of Medicine at Mount Sinai
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- GCO 18-0061
- U01DK119200 (US NIH Stipendium/Vertrag)
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