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Medication Adherence in Children Who Had a Liver Transplant (MALT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01154075
Recruitment Status : Completed
First Posted : June 30, 2010
Last Update Posted : December 25, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease
Pediatric Recipients of a Liver Transplant

Detailed Description:
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.

Study Design

Study Type : Observational
Actual Enrollment : 401 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Medication Adherence in Children Who Had a Liver Transplant
Study Start Date : August 2010
Primary Completion Date : June 2015
Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Rejection episodes [ Time Frame: Quarterly for 2 years unless a rejection occurs within this time frame. ]
    Adherence measured through the use of the standard deviation of a series of tacrolimus blood levels obtained during the course of follow-up is the primary predictor.

Secondary Outcome Measures :
  1. Retransplantation or death [ Time Frame: 2 years ]
  2. Liver function tests [ Time Frame: Quarterly for 2 years unless a rejection occurs within this time frame. ]

Biospecimen Retention:   Samples Without DNA
liver tissue samples (from biopsies performed for clinical, not investigational, reasons)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric patients receiving liver transplantation

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01154075

United States, California
UCLA Medical Center
Los Angeles, California, United States, 90095
United States, Illinois
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
United States, Pennsylvania
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Children's Hospital Medical Center, Cincinnati
University of Pittsburgh
Ann & Robert H Lurie Children's Hospital of Chicago
University of California, Los Angeles
The EMMES Corporation
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Eyal Shemesh, MD Icahn School of Medicine at Mount Sinai
More Information

Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01154075     History of Changes
Other Study ID Numbers: GCO 09-1112
R01DK080740 ( U.S. NIH Grant/Contract )
First Posted: June 30, 2010    Key Record Dates
Last Update Posted: December 25, 2017
Last Verified: December 2017

Keywords provided by Icahn School of Medicine at Mount Sinai:
Liver transplant