Improving Medication Adherence in Adolescents Who Had a Liver Transplant (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).

Study Overview

• Status: Active, not recruiting
• Conditions: Transplant
• Intervention / Treatment: Behavioral: Telemetric Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 148
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kinga Picerno, M.S.Ed.; Phone Number: 212-241-2842; Email: Kinga.Picerno@mssm.edu
• Study Contact Backup: Name: Rachel Annunziato, Ph.D.; Phone Number: 212-659-8776; Email: Rachel.Annunziato@mssm.edu

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G1X8
      • The Hospital for Sick Children Toronto
• United States
  • California
    • Los Angeles, California, United States, 90027
      • Children's Hospital Los Angeles
    • Los Angeles, California, United States, 90095
      • Mattel Children's Hospital UCLA
    • San Francisco, California, United States, 94107
      • Benioff Children's Hospital UCSF
  • Florida
    • Miami, Florida, United States, 33136
      • Miami Transplant Institute
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Children's Healthcare of Atlanta/Emory
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Lurie Children's Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • C.S.Mott Children's Hospital
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia
    • Pittsburgh, Pennsylvania, United States, 15224
      • Children's Hospital of Pittsburgh
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telemetric Intervention Arm; Adolescent with MLVI>2 to receive the telemetric intervention.	Behavioral: Telemetric Intervention; Calls, scripted by a manual; the frequency of the calls varies with patient's MLVI status and preferences.
No Intervention: Standard of Care Arm; Adolescent with MLVI>2 to receive standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: The Hospital for Sick Children; Baylor College of Medicine; Children's Hospital of Philadelphia; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University of California, Los Angeles; University of Miami; Columbia University; University of Pittsburgh; Seattle Children's Hospital; University of California, San Francisco; Ann & Robert H Lurie Children's Hospital of Chicago; Children's Hospital Los Angeles; Children's Hospital of Michigan; Emory-Children's Center
• Investigators: Principal Investigator: Eyal Shemesh, MD, Icahn School of Medicine at Mount Sinai

Publications and helpful links

General Publications

• 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.

Helpful Links

• Official Website of The iMALT Study

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2018
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: September 28, 2018
• First Submitted That Met QC Criteria: September 28, 2018
• First Posted (Actual): October 1, 2018

Study Record Updates

• Last Update Posted (Estimated): November 3, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Adherence; Intervention
• Other Study ID Numbers: GCO 18-0061; U01DK119200 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No