Telemetric Intervention for Liver Transplant Patients

(iMALT Trial)

Recruiting in Palo Alto (17 mi)

+12 other locations

Overseen by Eyal Shemesh, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Icahn School of Medicine at Mount Sinai

No Placebo Group

Trial Summary

What is the purpose of this trial?

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).

Research Team

Eyal Shemesh, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

This trial is for adolescents aged 12-19 who had a liver transplant at least 2.5 years ago and are struggling with taking their medication regularly, as shown by high MLVI scores. They must be on tacrolimus and have guardian consent to participate. It's not for those who've had other organ transplants, might need another one soon, will change medical services in the next two years, are pregnant or were recently hospitalized.

Inclusion Criteria

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

I am between 12 and 19 years old.

It has been over 2.5 years since my last liver transplant.

Exclusion Criteria

The patient is expected to transition to another service (e.g., adult clinic, another hospital) during the two years of the study

A temporary exclusion: the patient is not medically stable or was hospitalized for >48 consecutive hours in the past three months

I have had an organ transplant, but it was not the liver.

Treatment Details

Interventions

• Telemetric Intervention (Behavioral Intervention)

Trial Overview The study is testing a special telemetric program designed to help these teens take their medicine more consistently to prevent rejection of their transplanted liver. The effectiveness of this personalized tech-based intervention is measured against the variability in their medication levels over time.

Participant Groups

Group I: Telemetric Intervention Arm Experimental Treatment 1 Intervention

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

Group II: Standard of Care Arm Active Control 1 Intervention

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Columbia University Medical Center New York, NY

Children's Hospital of Philadelphia Philadelphia, PA

Children's Hospital of Pittsburgh Pittsburgh, PA

Texas Children's Hospital Houston, TX

More Trial Locations

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Dr. Brendan Carr

Icahn School of Medicine at Mount Sinai

Chief Executive Officer since 2024

MD, MA, MS

Dr. Vicki LoPachin

Icahn School of Medicine at Mount Sinai

Chief Medical Officer

MD, FACP, MBA

Children's Hospital of Philadelphia

Collaborator

Trials

749

Recruited

11,400,000+

Joseph W. St. Geme III

Children's Hospital of Philadelphia

Chief Medical Officer since 2021

MD, PhD, MPH

Madeline Bell

Children's Hospital of Philadelphia

Chief Executive Officer since 2015

BSc in Nursing from Villanova University, MSc in Organizational Dynamics from the University of Pennsylvania

Seattle Children's Hospital

Collaborator

Trials

319

Recruited

5,232,000+

Dr. Jeff Sperring

Seattle Children's Hospital

Chief Executive Officer since 2015

MD from Indiana University School of Medicine

Dr. Jeff Ojemann

Seattle Children's Hospital

Chief Medical Officer since 2022

MD from Washington University in St. Louis

University of Miami

Collaborator

Trials

976

Recruited

423,000+

Sylvia Daunert

University of Miami

Chief Executive Officer since 2011

PhD in Biochemistry and Molecular Biology, University of Kentucky

Bahar Motlagh

University of Miami

Chief Medical Officer since 2021

PhD in Biomedical Engineering, Ecole Polytechnique Montreal

Emory-Children's Center

Collaborator

Trials

5

Recruited

5,001,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2513

Recruited

4,366,000+

Dr. Griffin P. Rodgers

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Chief Executive Officer since 2007

MD, M.A.C.P.

Dr. Griffin P. Rodgers

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Chief Medical Officer since 2007

MD, M.A.C.P.

University of Pittsburgh

Collaborator

Trials

1820

Recruited

16,360,000+

David Apelian

University of Pittsburgh

Chief Executive Officer since 2019

PhD in Molecular Biology from Rutgers University, MD from the University of Medicine and Dentistry of New Jersey, MBA from Quinnipiac University

Pamela D. Garzone

University of Pittsburgh

Chief Medical Officer

PhD in Clinical Science from the University of Pittsburgh

Ann & Robert H Lurie Children's Hospital of Chicago

Collaborator

Trials

275

Recruited

5,182,000+

Dr. Michael D. Kelleher

Ann & Robert H Lurie Children's Hospital of Chicago

Chief Medical Officer since 2012

MD from University of Chicago

Dr. Thomas Shanley

Ann & Robert H Lurie Children's Hospital of Chicago

Chief Executive Officer since 2019

MD from University of Chicago Pritzker School of Medicine

The Hospital for Sick Children

Collaborator

Trials

724

Recruited

6,969,000+

Dr. Ronald D. Cohn

The Hospital for Sick Children

Chief Executive Officer since 2019

MD from University of Düsseldorf, Germany

Dr. Lennox Huang

The Hospital for Sick Children

Chief Medical Officer since 2016

MD from McGill University

Children's Hospital Los Angeles

Collaborator

Trials

257

Recruited

5,075,000+

Paul S. Viviano

Children's Hospital Los Angeles

Chief Executive Officer since 2015

Master of Public Health from UCLA Fielding School of Public Health

Alan S. Wayne

Children's Hospital Los Angeles

Chief Medical Officer since 2023

MD