TransplantiMALTNCT03691220
Improving Medication Adherence in Adolescents Who Had a Liver Transplant
A study testing Telemetric Intervention in people with Transplant, run by Icahn School of Medicine at Mount Sinai at 13 sites in 2 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 12 to 19 years
- Conditions the study is for
- Transplant
- What is being tested?
- Telemetric Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 14 Nov 2018to 22 Oct 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States12 sites
C.S.Mott Children's Hospital
Ann Arbor, Michigan, 48109
Children's Healthcare of Atlanta/Emory
Atlanta, Georgia, 30322
Lurie Children's Hospital
Chicago, Illinois, 60611
Texas Children's Hospital
Houston, Texas, 77030
Children's Hospital Los Angeles
Los Angeles, California, 90027
Mattel Children's Hospital UCLA
Los Angeles, California, 90095
Miami Transplant Institute
Miami, Florida, 33136
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Columbia University Medical Center
New York, New York, 10032
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Benioff Children's Hospital UCSF
San Francisco, California, 94107
About this study
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).
Read the 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.
- Conditions
- Transplant
- Being tested
- Telemetric Intervention
- Keywords
- Intervention, Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemetric InterventionBehavioural
Calls, scripted by a manual; the frequency of the calls varies with patient's MLVI status and preferences.
| Study group | Role | What they receive |
|---|---|---|
| Telemetric Intervention Arm | Experimental | Adolescent with MLVI>2 to receive the telemetric intervention. Receives: Behavioral: Telemetric Intervention |
| Standard of Care Arm | No intervention | Adolescent with MLVI>2 to receive standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing at Least One Episode 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), was assumed to have experienced a rejection for the purpose of the primary analysis.
Measured: 2 Years
Secondary outcomes (11)
The Standard Deviation of A Series Of Tacrolimus Levels (MLVI)
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.
Measured: 2 Years
Number of Participants With Locally and Centrally Determined Rejection by Biopsy
Number of Participants with Locally and Centrally Determined Rejection Biopsy Proven Rejection
Measured: 2 Years
Number of Locally Determined Rejections by Biopsy Per Patient During Follow-up
Rate Of Locally Determined Biopsy Proven Rejection determined by Number of locally determined rejections by biopsy per patient during follow-up
Measured: 2 Years
Time to First Locally Rejection From Enrollment
Time to first locally determined rejection by biopsy from enrollment
Measured: about 12 months
Time to First Centrally Determined Rejection
Time, in months, to first centrally determined rejection by biopsy from enrollment
Measured: up to 12 months
Occurrence of Death
Number of deaths
Measured: 2 Years
Occurrence of Re-Listing For Transplantation
Number of participants listing for retransplantation
Measured: 2 Years
Number of Participants With ALT >150 U/L
Number of Participants achieving above the predetermined threshold alanine trans aminase (ALT) > 150
Measured: 2 Years
Mean and Maximal ALT Level
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)
Measured: 2 Years
Number of Participants Achieving Mean GGT > 150
Number of participants achieving mean number above threshold GGT > 150 Gamma Glutamyl Transferase (gGT)
Measured: 2 Years
Mean and Maximal gGT
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)
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start14 Nov 2018
- Primary completion22 Oct 2025
- Study completion22 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for TransplantStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study participants will be randomized to receive the telemetric intervention or standard of care.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles, Ann & Robert H Lurie Children's Hospital of Chicago, Baylor College of Medicine, University of Pittsburgh, University of California, San Francisco, Children's Hospital of Michigan, Children's Hospital of Philadelphia, Emory-Children's Center, The Hospital for Sick Children, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Columbia University, Seattle Children's Hospital, University of Miami, Children's Hospital Los Angeles
- Responsible party
- Principal investigator, Eyal Shemesh, Icahn School of Medicine at Mount Sinai
- Investigators
- Eyal Shemesh, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03691220
- Sponsor's protocol ID
- GCO 18-0061
- Other IDs
- U01DK119200
- Acronym
- iMALT
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2018
- Last updated
- 30 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 42208859Tutino 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.
PubMed 40465085Mellon 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.
PubMed 36094829