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Medication Adherence in Children Who Had a Liver Transplant

NCT ID: NCT01154075

Last Updated: 2017-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

401 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Study Completion Date

2015-06-30

Brief Summary

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The purpose of this study is to evaluate the use of a novel method to measure adherence to immunosuppressant medications in predicting rejection episodes in children who had a liver transplant.

Detailed Description

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During the course of their illness as many as 50% of children who had a liver transplant stop taking their medications. Non-adherence is the most important reason for organ rejection in long term survivors of pediatric liver transplantation. In order to address this important risk-factor effectively, the first step is to evaluate a method that would identify non-adherence in these children. Medication blood levels that are obtained as a part of clinical practice in transplant centers can be used to determine whether the patient is adherent or not. This multi-center observational study tests the ability of an objective measure of adherence to immunosuppressant medications that involves the use of routinely obtained tacrolimus blood levels to predict organ rejection in children who had a liver transplant.

Conditions

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Pediatric Recipients of a Liver Transplant

Keywords

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Liver transplant Adherence Compliance Tacrolimus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* The patient is between \> 1 year of age and less than 18 years of age at enrollment
* Guardian's consent, child assent (in accordance with each institution's IRB policies).
* The patient is prescribed tacrolimus (either brand or generic formulation).
* The patient has been seen in the enrolling center's clinic at least once in the last two years.

Exclusion Criteria

* The patient received a liver transplant less than 1 year prior to enrollment.
* The patient has had more than one solid organ transplant (including marrow replacement).
* The patient has had biopsy-proven rejection within the past six months.
* The patient has been diagnosed with Hepatitis C.
* The guardian or child (in a developmentally-appropriate manner) do not understand the study procedures. This will be verified by asking both guardian and child (if 6 years old or older) to repeat the study procedures.
* The patient is only seen for consultation - most or all of the child's routine care is provided at another center (or in a community clinic).
* Either the patient or the guardian is actively psychotic or severely disoriented due to any cause, including hepatic encephalopathy (temporary exclusion) or severely mentally retarded as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV).
* The patient is not medically stable or is hospitalized.
* The treating physician has instructed the participant not to obtain tacrolimus levels for at least one year.
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role collaborator

Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role collaborator

The Emmes Company, LLC

INDUSTRY

Sponsor Role collaborator

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

NIH

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eyal Shemesh, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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UCLA Medical Center

Los Angeles, California, United States

Site Status

Children's Memorial Hospital

Chicago, Illinois, United States

Site Status

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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Shemesh E, Bucuvalas JC, Anand R, Mazariegos GV, Alonso EM, Venick RS, Reyes-Mugica M, Annunziato RA, Shneider BL. The Medication Level Variability Index (MLVI) Predicts Poor Liver Transplant Outcomes: A Prospective Multi-Site Study. Am J Transplant. 2017 Oct;17(10):2668-2678. doi: 10.1111/ajt.14276. Epub 2017 Apr 22.

Reference Type RESULT
PMID: 28321975 (View on PubMed)

Other Identifiers

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R01DK080740

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GCO 09-1112

Identifier Type: -

Identifier Source: org_study_id