Improving Medication Adherence in Adolescents Who Had a Liver Transplant



Status:Recruiting
Healthy:No
Age Range:12 - 17
Updated:2/21/2019
Start Date:November 14, 2018
End Date:September 30, 2023
Contact:Kinga Picerno, M.S.Ed.
Email:Kinga.Picerno@mssm.edu
Phone:212-241-2842

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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).

This is a prospective, multi-center, randomized controlled trial. The study will be conducted
in 11 transplant centers in the United States and Canada. Estimated final sample size of 140.
Pediatric adolescent and young adult (age at enrollment ≥12 and < 18) 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.

Inclusion Criteria:

- The patient is ≥ 12 and < 18 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.
We found this trial at
11
sites
3414 Fifth Avenue
Pittsburgh, Pennsylvania 15213
Principal Investigator: George Mazariegos, MD
Phone: 412-692-5201
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Principal Investigator: Elizabeth Rand, MD
Phone: 215-590-7801
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Ann Arbor, Michigan 48109
Principal Investigator: Emily M Fredericks, PHD
Phone: 734-615-4271
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Atlanta, Georgia 30322
Principal Investigator: Rene Romero, MD
Phone: 404-727-5383
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Chicago, Illinois 60611
Principal Investigator: Estella Alonso, MD
Phone: 312-227-4557
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Chicago, IL
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6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Principal Investigator: Tamir Miloh, MD
Phone: 832-824-0411
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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Los Angeles, California 90095
Principal Investigator: Robert S Venick, MD
Phone: 310-825-4349
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Los Angeles, CA
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Principal Investigator: Eyal Shemesh, MD
Phone: 212-241-2842
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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San Francisco, California 94107
Principal Investigator: Emily Perito, MD
Phone: 415-502-6346
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4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Principal Investigator: Niviann Blondet, MD
Phone: 206-987-1037
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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555 University Avenue
Toronto, Ontario M5G 1X8
Principal Investigator: Vicky Ng, MD
Phone: 416-813-7654
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Toronto,
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