Zlepšení adherence k lékům u dospívajících, kteří podstoupili transplantaci jater (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).
Přehled studie
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Ontario
-
Toronto, Ontario, Kanada, M5G1X8
- The Hospital For Sick Children Toronto
-
-
-
-
California
-
Los Angeles, California, Spojené státy, 90027
- Children's Hospital Los Angeles
-
Los Angeles, California, Spojené státy, 90095
- Mattel Children's Hospital UCLA
-
San Francisco, California, Spojené státy, 94107
- Benioff Children's Hospital UCSF
-
-
Florida
-
Miami, Florida, Spojené státy, 33136
- Miami Transplant Institute
-
-
Georgia
-
Atlanta, Georgia, Spojené státy, 30322
- Children's Healthcare of Atlanta/Emory
-
-
Illinois
-
Chicago, Illinois, Spojené státy, 60611
- Lurie Children's Hospital
-
-
Michigan
-
Ann Arbor, Michigan, Spojené státy, 48109
- C.S.Mott Children's Hospital
-
-
New York
-
New York, New York, Spojené státy, 10032
- Columbia University Medical Center
-
New York, New York, Spojené státy, 10029
- Icahn School of Medicine at Mount Sinai
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Spojené státy, 19104
- Children's Hospital of Philadelphia
-
Pittsburgh, Pennsylvania, Spojené státy, 15224
- Children's Hospital of Pittsburgh
-
-
Texas
-
Houston, Texas, Spojené státy, 77030
- Texas Children's Hospital
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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. |
|
Žádný zásah: Standard of Care Arm
Adolescent with MLVI>2 to receive standard of care. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Number of Participants Experiencing at Least One Episode of Rejection
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
The Standard Deviation of A Series Of Tacrolimus Levels (MLVI)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: about 12 months
|
Time to first locally determined rejection by biopsy from enrollment |
about 12 months
|
|
Time to First Centrally Determined Rejection
Časové okno: up to 12 months
|
Time, in months, to first centrally determined rejection by biopsy from enrollment |
up to 12 months
|
|
Occurrence of Death
Časové okno: 2 Years
|
Number of deaths |
2 Years
|
|
Occurrence of Re-Listing For Transplantation
Časové okno: 2 Years
|
Number of participants listing for retransplantation |
2 Years
|
|
Number of Participants With ALT >150 U/L
Časové okno: 2 Years
|
Number of Participants achieving above the predetermined threshold alanine trans aminase (ALT) > 150 |
2 Years
|
|
Mean and Maximal ALT Level
Časové okno: 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
Časové okno: 2 Years
|
Number of participants achieving mean number above threshold GGT > 150 Gamma Glutamyl Transferase (gGT) |
2 Years
|
|
Mean and Maximal gGT
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Eyal Shemesh, MD, Icahn School of Medicine at Mount Sinai
Publikace a užitečné odkazy
Obecné publikace
- 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.
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- GCO 18-0061
- U01DK119200 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .