NCT03691220

Brief 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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
2 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 1, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

November 14, 2018

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2025

Completed
Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

6.9 years

First QC Date

September 28, 2018

Last Update Submit

January 6, 2026

Conditions

Transplant

Keywords

InterventionAdherence

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • The Standard Deviation of A Series Of Tacrolimus Levels (MLVI)

    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

  • +6 more secondary outcomes

Study Arms (2)

Telemetric Intervention Arm

EXPERIMENTAL

Adolescent with MLVI\>2 to receive the telemetric intervention.

Behavioral: Telemetric Intervention

Standard of Care Arm

NO INTERVENTION

Adolescent with MLVI\>2 to receive standard of care.

Interventions

Telemetric InterventionBEHAVIORAL

Calls, scripted by a manual; the frequency of the calls varies with patient's MLVI status and preferences.

Telemetric Intervention Arm

Eligibility Criteria

Age12 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Mattel Children's Hospital UCLA

Los Angeles, California, 90095, United States

Location

Benioff Children's Hospital UCSF

San Francisco, California, 94107, United States

Location

Miami Transplant Institute

Miami, Florida, 33136, United States

Location

Children's Healthcare of Atlanta/Emory

Atlanta, Georgia, 30322, United States

Location

Lurie Children's Hospital

Chicago, Illinois, 60611, United States

Location

C.S.Mott Children's Hospital

Ann Arbor, Michigan, 48109, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

The Hospital For Sick Children Toronto

Toronto, Ontario, M5G1X8, Canada

Location

Related Publications (1)

  • 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.

    PMID: 36094829DERIVED

Related Links

Study Officials

  • Eyal Shemesh, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Study pathologists will perform masked reading of for-cause biopsy slides.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Study participants will be randomized to receive the telemetric intervention or standard of care.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 28, 2018

First Posted

October 1, 2018

Study Start

November 14, 2018

Primary Completion

October 22, 2025

Study Completion

October 22, 2025

Last Updated

January 7, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)US(12)